The Pharma Legal Handbook: Norway
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Regulation, Pricing, Clinical Trials, Marketing, Manufacturing, Trademarks, Patents and more!
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May 2020
1. Regulatory Reforms: Norway
1. Are there proposals for reform or significant change to the healthcare system?
The most relevant changes to the Norwegian healthcare system expected to enter into force in the near future are the following:
The new EU regulation on clinical trials on medicinal products for human use, Regulation (EU) 536/2014, which has been implemented in the Norwegian Medicines Regulation Section 15-6a will replace the provisions in the current regulations on clinical trials which implements EU Directive 2001/20/EC once the EU Portal and EU Database have been successfully established. The main changes are:
- a harmonized electronic submission and assessment process for clinical trials conducted in multiple Member States including the EEA EFTA States;
- an improved collaboration, information-sharing and decision-making between and within Member States and EEA EFTA States;
- an increased transparency of information on clinical trials;
- the highest standards of safety for all participants in EEA/ EU clinical trials.
More information is available.
2. When are they likely to come into force?
In relation to the above, the following applies:
Regulation (EU) 536/2014 has been implemented into the EEA Agreement, and been implemented into Norwegian law. As the entry into force will depend on when the EU Portal and EU Database have been successfully established in accordance with Art. 82 of the Regulation, the entry into force is still uncertain. However, as of May 2021 audit of the EU Portal and EU Database is expected to commence by 31 January 2022, which implies that the Regulation, is not likely to enter into force in Norway until 2022.
Also from this Legal Handbook
2. Patents & Trademarks: Norway
1. What are the basic requirements to obtain patent and trademark protection?
a) Patents
The requirements for obtaining patents and the protection thereof is regulated by the Norwegian Patent Act ( LOV-1967-12-15-9).
The basic requirements for obtaining a patent are:
- An invention within a technical field susceptible of industrial application (section 1).
- The invention must be novel on the day of application (section 2).
- The invention must involve an inventive step (section 2).
In addition, some specific types of inventions, which may fulfil the basic requirements above, may not be patentable (see question 3).
Once granted, a patent grants its owner the exclusive right to the invention, including the right to profit from its applications, for 20 years from the date of filing the application. This entails that the patent owner can prevent any third parties from, i.a., producing, using, marketing, selling or importing any product implementing the technology covered by the patent, without the patent owner’s consent.
Patents in the pharmaceutical sector may obtain an additional exclusivity period up of five years following the expiry of the patent, through the rules regarding supplementary protection certificates (“SPC” nw. supplerende beskyttelsessertifikater). As described in the previous chapters, especially Chapter 1 and 2, the process for obtaining MA for medicines is complicated, costly and time consuming. Since patent applications usually are filed in an early stage of the development of new medicines, it can take several years from the application until the inventor can market the inventions, and thus get economic returns for its investments. To make up for the lost “effective” patent period, an SPC grants exclusivity an extended period after the regular patent protection expires. The additional SPC protection is calculated as follows; the time passed between the filing of the patent and being granted MA minus five years. Thus, if the process of obtaining MA has taken less than five years from the patent application, no SPC protection is granted. The additional SPC protection may not exceed five years.
b) Trademarks
The requirements for obtaining trademarks and regulation thereof is regulated by the Norwegian Trademark Act (LOV-2010-03-26-8).
The basic requirements for obtaining a trademark are:
- That it constitutes signs that can be reproduced graphically in the official register in a way that makes the scope of the protection granted clear. The sign may be i.a. words, slogans, names, product shapes, color(s), pictures, sounds (section 14 and section 2)
- The sign must be distinctive as a trademark for the goods and services it seeks registration for. I.e. it must differentiate the products and/or services of a company from the products and/or services of other companies. This entails that trademarks that exclusively or only with insignificant changes or additions, consists of signs that indicate the kind, quality, quantity, intended purpose of the goods or services cannot be registered (section 14).
- The mark must not be descriptive of the goods and services of which it is sought registered.
- The use of the trademark would not infringe the rights of another entity in Norway (section 16).
In addition some types of marks, which may fulfil the basic requirements above, may not be registered as trademarks (see question 3).
Once granted, the trademark grants its owner the exclusive right to use the trademark. Particularly, the trademark owner is entitled to prevent commercial third parties, from:
- Using signs that are identical to the trademark in relation to identical products and/or services.
- Using signs that are identical or similar to the trademark in relation to identical and/or similar products and/or services if there is a likelihood of confusion between the two.
- If the registered trademark is considered “well-known” in the realm, some additional protection is granted (Kodak-protection). If the trademark is well-known, it is protected against third party use of identical or similar (note, similar is a lower threshold than likelihood of confusion) trademark for similar or any other goods or services, if the use of that sign would take unfair advantage of, or is detrimental to, the distinctive character or repute (goodwill) of the well-known trademark.
Trademarks are granted for ten years from the date of application. The registration can be renewed unlimitedly for additional periods of ten years.
2. What agencies or bodies regulate patents and trademarks?
Both trademarks and patents are regulated by the Norwegian Industrial Property Office (“NIPO”). NIPO is the competent agency for:
- examining patent and trademark applications;
- granting patent and trademark registration;
- applying for renewal (trademarks) or SPC protection (patents);
- deciding on opposition to trademark or patent applications or registrations.
Furthermore, the ordinary civil courts have jurisdiction over claims relating to patent and/or trademark rights, including nullity and infringement claims.
3. What products, substances, and processes can be protected by patents or trademarks and what types cannot be protected?
a) Patents
All products, substances and processes fulfilling the general requirements of patentability in the Patent Act section 1 and 2 (see question 1 a) can be patented, subject to some explicit exceptions listed below.
The Patent Acts section 1 also exemplifies some subject matters not regarded as inventions:
- discoveries, scientific theories and mathematical methods;
- aesthetic creations;
- schemes, rules or methods for performing intellectual, gambling or business activities and software; and
- presentations of information.
Further, the following subject matters are not subject to patent protection;
- methods for surgical or therapeutic treatment or diagnostic methods, practiced on humans or animals. Please note that this does not prevent grant of patents for products for use in such methods.
- plant or animal varieties;
- biological processes to produce plants or animals;
- inventions where their commercial exploitation would be contrary to public order or morality.
b) Trademarks
All marks fulfilling the general requirements for trademark protections in the Trademark Act (see question 1 b) can be registered, subject to some explicit exceptions listed below:
- signs that consist exclusively of a shape that results from the nature of the goods themselves, is necessary to obtain a technical result or adds substantial value to the goods (section 2);
- contrary to law or public order or is liable to cause offence;
- is capable to deceive, e.g. in respect to the nature, quality or geographical origin of the goods or services; and
- marks that violate the Penal code section 165 and 166 (use of flags, public uniforms, Norwegian or foreign official coat of arms, mark or seal)
4. How can patents and trademarks be revoked?
a) Patents
Patents may be revoked by either filing a request for an administrative review to NIPO or a suit to the ordinary courts. Filing administrative reviews to NIPO is intended as a quick, simple and cheap alternative to ordinary court proceedings.
A patent may be revoked if the requirements of section 1 and 2 of the Patent Acts (see question 1 a) are not fulfilled or it is unlawful (see question 3 a).
b) Trademarks
Trademarks may also be revoked by filing a request for an administrative review to NIPO or a suit to the ordinary courts.
A trademark may be revoked if it is deemed invalid, degenerated or in case of non-use of the mark.
- A mark is invalid if it does not fulfil the requirements of registration pursuant to the Trademark Act, see question 1 b) or if it was unlawful on the date of registration or since has become unlawful, see question 3 b)
- A mark is considered degenerated if it has lost its distinction and has become a general designation in the relevant market/industry for goods or services of the type for which it is registered.
- The mark can also be revoked if the trademark holder (or authorized licensee) did not use the mark within five years following registration or if the use has stopped for five consecutive years, without legitimate reasons.
5. Are foreign patents and trademarks recognized and, if so, under what circumstances?
a) PatentsThe Norwegian system does not automatically recognize foreign patents. However, foreign patents may obtain protection in Norway through the following application procedures:
- International patent application procedure (“PCT”);
- European patents filed through the European patent Office (“EPO”) can later be made applicable in Norway (validated).
The international patent application procedure was established through the Patent Cooperation Treaty. Through this path, the applicant may apply for patents in various jurisdictions (signees to the patent Cooperation Treaty) by filing a single application. The applicant must indicate Norway among the countries where he/she seeks protection
To validate a European patent in Norway the applicant must file an application for validation as well as a Norwegian translation latest three months after the European Grant Date.
b) TrademarksAs with patents, the Norwegian system does not automatically recognize foreign trademarks. However, foreign applicants may obtain trademark protection in Norway through the following application procedures
- International trademark applications (“WIPO”).
The international trademark application was established by the Madrid Protocol and the Madrid Agreement. Through the Madrid system for the international registration of marks, it is possible to protect a mark in a large number of countries by obtaining an effect in each of the designated jurisdiction (that is a contracting party to the Madrid system). To obtain protection in Norway the applicant/trademark holder must designate Norway as a jurisdiction for protection.
In addition, anyone who has filed an application for registration of a trademark in a foreign state that is a party to the Paris Convention of 20 March 1883 for the Protection of Industrial Property or the WTO Agreement of 15 April 1994 Establishing the World Trade Organization and who, within six months thereafter, applies for registration of the trademark in Norway, may claim that the new application be considered to have been filed at the same time as the first application.
6. Are there any non-patent/trademark barriers to competition to protect medicines or devices?
The most relevant non-patent/trademark barriers for the protection of medicines or devices are the protection granted to trade secrets.
Trade secrets are currently i.a, regulated by the Trade Secrecy Act (LOV-2020-03-27-15) which incorporates Directive (EU) 2016/943 on the protection of undisclosed know-how and business information (trade secrets) against their unlawful acquisition, use and disclosure. In order for information to be protected by the Act, is has to;
- be secret, meaning that they are not commonly known or easily assessible;
- have a commercial value, because they are secret; and
- the owner of the information must have implemented reasonable efforts to ensure secrecy.
The Act does not protect information that is publicly available or easily accessible. The information has a commercial value if the marked is willing to offer remuneration or other economic benefits for access to the information, or if the information gives the owner an advantage when used in its own business. General experience and skills that an employee has acquired during the employment does not constitute a trade secret.
The Trade Secrecy Act prohibits any intervention in of others trade secrets, and this include getting access to the information, copying, spreading or using the information. In the event of a breach of the Act, the owner of the trade secret may seek damages and compensation, while the infringer may be fined or sanctioned with prison. Moreover, the court may order for the destruction of documents and objects, or the delivery back to the owner.
The protection against unlawful use of trade secrets does not only cover situation where the infringer has actual knowledge that the information in question were trade secrets, but also where he/she should have known that the information in question were trade secrets.
If the infringer is found to be in good faith, the court may allow him to continue to use the information against a reasonable remuneration if this would lead to a reasonable solution to the infringement.
Sanctions against the infringer will only be possible if the owner of the trade secrets initiates legal steps no later than three years after he or she acquired or should have acquired the necessary knowledge of the infringement and the infringer.
Additionally, for the public sector, the Administration Act Section 13 contains regulations protecting trade secrets (duty of confidentiality). For medicines, the Medicines Act Section 30 provides similar protection. Breach of statutory confidentiality duty may be sanctioned under the Penal Code Section 209.
7. Are there restrictions on the types of medicines or devices that can be granted patent and trademark protection?
We refer to our answer above in question 1 and question 3, which outlines the general requirements for obtaining trademark and patent protection, as well as some explicit exceptions. For medicines and medical devices please note that the Patent Act provides that no patent protection may be granted to diagnosis methods or surgical or therapeutic treatments applied to the human or animal bodies. As noted in question 3 a) above, patent protection may be offered to products used in such treatments or methods.8. Must a patent or trademark license agreement with a foreign licensor be approved or accepted by any government or regulatory body?
Neither patents nor trademark licenses with foreign licensors require governmental or regulatory approval in Norway.
Furthermore, there are no requirements to register either trademark or patent licenses for them to be valid and enforceable. However, transfer of a patent, a patent application or a supplementary protection certificate to third parties or the grant of a license shall be recorded in the Patent Register or the Register of the NIPO Office for European patent applications at the request of one of the parties. If such registration has taken place, the licensee has legal protection against i.a. seizure by the licensor’s bankruptcy estate.
Also from this Legal Handbook
3. Product Liability: Norway
1. What types of liability are recognized in your jurisdiction?
Norwegian law recognizes the following types of liability
- Criminal liability, for violation of the Norwegian Penal Code or where criminal liability is stipulated by law (such as the Medicines Act, the Medical Devices Act)
- Liability for breach of contract
- Liability for torts, including i.a. negligence and product liability
2. How do these types of liabilities apply to the manufacturers of medicines and devices?
a) General
The Product Liability Act (LOV-1988-12-23-104) sets out a strict (no-fault) liability regime for defect products in Norway.
Pursuant to section 2-1 the manufacturer is liable for damages caused by its defective products. A product is defective if it does not offer the level of safety that a person is entitled to expect, when taking into account inter alia the way the product is marketed, its manifest characteristics, instructions of use, warnings and reasonable intended use of the product.
When it comes to medicinal products, some deviating regulation applies, see below under b).
The concept of a manufacturer is defined broadly and encompass all entities that:
- Manufactures the finished products;
- manufactures a component included in the finished product;
- any person who by putting his name, trademark or other distinguishing feature on the product and thus presents himself as its manufacturer;
- the retailer of a product, when it is difficult to identify the manufacturer from the product itself and the retailer does not provide the name or address of the manufacturer within reasonable time;
- the importer of a product imported from outside EEA; or
- the retailer of a product imported from outside EEA, if the importers name or address in Norway is not provided within reasonable time.
- Liability under the Product Liability Act covers damages to both natural persons and property.
The injured party has to prove the defect, the damage suffered and the causal link between the defect and the damage suffered. As noted above, the Product Liability Act is a strict liability regime which entails that the injured party does not have to prove the manufacturer’s negligence.
b) Medicinal Products
The Product Liability Act chapter 3 provides a special regulation for damages to natural persons caused by pharmaceuticals, both for in sale pharmaceuticals and under trials (e.g. clinical trials).
Under the Norwegian regime all manufacturers of pharmaceuticals are obligated to be members of the Drug Liability Association. The members pay a premium to the Drug Liability Association’s product liability insurance. The premium is based on the member’s annual drug turnover. The maximum compensation is MNOK 80 per year, cf. section 3-6. For producer liability under chapter 2 of the Product Liability Act, additional liability insurance is needed for damages above this threshold.
The Product Liability Act section 3-3 provides that in case of damages to natural persons caused by pharmaceuticals the Drug Liability Association’s insurance is liable, irrespective of fault and irrespective of whether the damage is caused by a defect. In essence the liability for damages caused by pharmaceuticals are even stricter than the general liability under the Product Liability Act section 2-1.
Unless the damage is caused by a defect (in which case the Drug Liability Association’s insurance is liable unless the exceptions in section 2-2 applies) the Drug Liability Association’s insurance is not liable to the extent the damage is:
- A consequence of a wrong delivery or a mistake of drugs or other negligence at a pharmacist, at a physician’s surgery, in a hospital, or by another distributor,
- caused in some other manner than by the foreseeable use of the drug, including use contrary to a properly issued and specific warning or incorrect use owing to neglect on the part of the physician in the form of a wrong prescription or inadequate advice,
- a consequence of the drug’s lack of effect or lack of sufficient effect, or
- due to side-effects which, in view of the injured party’s situation, it is reasonable for him to take the consequences of. In this assessment, emphasis shall be given to his health before use, the importance of the drug to his illness, the anticipated and actual effects of the drug, the nature and extent of the injury and the other circumstances of the case.
3. Does potential liability extend to the manufacturer only or could claims extend to corporate executives, employees, and representatives?
Liability under the Product Liability Act extends only to the manufacturer, i.e. the legal entity, or in the case of medicines, the Drug Liability Association’s insurance.
However, criminal liability arising out of damages caused by defective products may be addressed to natural persons, such as the CEO or other corporate executives of the manufacturer. However, all requirements for criminal culpability must be met for the individual person. There is no objective criminal liability for top management.
Similarly, for corporate executives, employees, and representatives, liability would (otherwise) presuppose negligence or intent.
4. How can a liability claim be brought?
Any liability claim, including claims for product liability, may be brought through the ordinary courts by the individual harmed. The injured party may file a lawsuit within three years from the day he/she should have been aware of the damage, the defect and the responsible party. In terms of product liability, the absolute statute of limitation is ten years from the day the defective product was put on the market for consumers. For medicines, the absolute statute of limitations is 20 years from the day the medicine was put on the market for consumers.
Liability claims for personal injury caused by medicines and medical devices can also be filed through the Norwegian System of Patient Injury Compensation (nw. Norsk Pasientskadeerstatning “NPE”). This a governmental agency under the Norwegian Ministry of Health and Care Services. NPE handles compensation claims from patients who think they may have suffered an injury from error or omission during the health care treatment. NPE handles claims for personal injury caused by medicines on behalf of the Drug Liability Association under the Product Liability Act. The claims handling is free of charge.
There is a board of appeal for personal injury caused by error or omission from HCPs, hospitals etc, e.g. if the dosage and use of the medicines is erroneous. If the personal injury is caused solely by the medicine itself, no such board of appeals exist and appeals have to be filed to the ordinary courts.
5. What defences are available?
The manufacturer may claim that there is no damage, no defect or no causal link between the damage caused and the defect.
In addition the Product Liability Act section 2-2 provides that the manufacturer is not liable if he can prove that he:
- did not place the product on the market;
- that the defect in the product did not exist at the time the product was placed on the market and that the defect or damage could not have been prevented or remedied afterwards; or
- that the defect was caused by the fact that the product is in compliance with invariable governmental rules and regulations.
In the case of medicines, there are two defences. If the liability is based on a defect, the exceptions above applies. If the liability is not based on a defect, i.e. that the defect is based on the separate rules regarding medicines, see question 54 b above the manufacturer may use the defences mentioned in question 2 b last paragraph.
Also from this Legal Handbook
4. Traditional Medicines and OTC Products: Norway
1. What are the regulatory requirements for traditional, herbal, complementary, or alternative medicines and devices?
The Medicines Act (LOV-1992-12-04-132) provides for an procedure for the MA of traditional medicines, including herbal and homeopathic medicines, whilst the new Medical Devices Act (LOV-2020-05-07-37) sets out details relating to equipment/devices.
a) Traditional medicine
- Import of pharmaceuticals from the EEA area (as well as procurement, storage, distribution, and export of pharmaceuticals) requires a wholesale permit, cf. the Medicines Act section 14 and the Regulation on wholesale business with medicines (FOR-1993-12-21-1219) section 2.
- Import of pharmaceuticals from countries outside the EEA generally requires an additional manufacturer’s license, cf. the Medicines Act (LOV-1992-12-04-132) section 13 and the Regulation on the manufacture and import of medicines (FOR-2004-11-02-1441) sections 3-1 and 3-3.
- Alternatively, brokers of pharmaceuticals (actors who offer the sale / purchase and (usually) receive commission / fee to provide the service, without owning the products) must register their activities with NoMA, see the Regulation on wholesale business with medicines (FOR-1993-12-21-1219) section 33a.
- However, holders of a Manufacturing and Importation Authorization (“MIA”) or a Wholesaler Distribution Authorization (“WDA”) issued within the EU/EEA can perform wholesaler activities in Norway for the products and activities covered by the MIA/WDA.
- NoMA must regardless be notified when such activities are planned.
- A list of the companies performing wholesaler activities in Norway based on a MIA or a WDA issued from a National Competent Authority within the EU/EEA is available here (Updated 7 July 2021), subject to frequent updates.
- There are special obligations for the distribution of pharmaceuticals for non-medical use, cf. the Regulation on sale of medicines for non-medical use (FOR-1983-03-01-628).
- Additionally, pharmaceuticals must comply with a number of regulatory requirements, including with regards to clinical assessments, quality control, labelling and marketing authorizations.
- A wholesale distributor who conducts business based on a Norwegian permit must appoint a Responsible Person (“RP”). This person must ensure that the company complies with the regulation on distribution of medicinal products. For wholesalers who carry out their own warehousing and/or wholesalers who carry out direct distribution the requirement for approval as RP is a M.Sc.Pharm. degree or equivalent, cf. the Regulation on wholesale business with medicines, section 6(FOR-1993-12-21-1219).
b) Herbal medicinal products
For herbal medicines the same application form is used and the documentation is organized in the format Common Technical Documents (CTD format) as for other medicines.
The documentation consists of the following modules:
- Administrative information
- Expert reports and summary of documentation. The summary should be made by an expert with the necessary professional qualifications.
- Quality documentation
- Preclinical documentation
- Clinical documentation
The European Commission’s website contains application forms and guidance for applicants in Notice to Applicants volume 2a
- Herbal and homeopathic medicine is also regulated in the Medicines Regulation, Sections 13-16 and 13-17
c) Medical equipment
- If the manufacturer of medical equipment has an authorized representative (“AR”) in the EU, it is not necessary to register with NoMA, cf. the Medical devices Regulations (FOR-2005-12-15-1690 .
- An authorised representative means any natural or legal person established in the EU/EEA-area who, explicitly designated by the manufacturer, acts and may be addressed by authorities and bodies in the EU/EEA-area instead of the manufacturer with regard to the latter’s obligations under the Medical Devices Regulation
- The authorised representative has a responsibility for internal control (including risk analysis and conformity assessment procedures)
- Medical devices must comply with a number of requirements, including for example:
- Before a medical device can be placed on the market, the manufacturer (or authorized representative) must conduct a conformity assessment.
- For a medical device in risk class higher than Class I the manufacturer must use a Notified Body to perform the conformity assessment.
- All labelling, instructions for use and information supplied by the manufacturer shall be in Norwegian.
- A medical device must be provided with, or have attached information necessary for the safe and proper use of the device, and when necessary users must be provided with sufficient training to safely use and handle the equipment.
- A market surveillance system for the medical device shall be established, ensuring that serious incidents and safety related corrective incidents are reported to the authorities.
- Incidents with medical devices on the market, as well as injuries, accidents and failures where medical devices are or may have been involved, shall be reported to NoMA.
d) Complementary and alternative medicine
With respect to “complementary, or alternative medicines” such as supplements, a variety of dietary supplements, vitamin and mineral products are often associated with the concept of health food and must be notified to the Norwegian Food Surveillance Authority (Nw. Mattilsynet). Health food stores shall register their activities to the Norwegian Food Safety Authority .
2. Can these traditional, herbal, complementary, or alternative products be advertised directly to the public?
See Marketing, Manufacturing, Packaging & Labeling, Advertising questions 7, 17, 19 and 20]a) Traditional Medicine
Yes, but advertisement of tradition medicine is regulated by the Medicine Act (LOV-1992-12-04-132) chapter VII, which sets out that advertisement shall be “sober and truthful”. Breach of this may even lead to recall of the MA, according the Medicines Regulation (FOR-2009-12-18-1839) in addition to a regulation on sale of medicine for non- medical use (FOR-1983-03-01-628) Advertising for medicines to the general public is only allowed for non-prescription drugs or medicines in packages that are exempt from prescription and when recommended exclusively for illnesses or symptoms that would not normally require examination or treatment by a physician, dentist, veterinarian or marine/ fish health biologist .
It is prohibited in advertising or the like by text or images, directly or indirectly, to state that a drug, or preparation other than drug is recommended as a means to prevent, cure or alleviate illness, disease symptoms or pain or affect physiological functions in humans or animals. Where special reasons exist, the Ministry may make exceptions to this provision. In the event of a violation, the Ministry may order the manufacturer or the advertiser to ensure that an approved correction is sent out or published in a manner similar to the illegal advertisement.
If, despite warning, advertising is still being conducted for a product in violation of the provisions in section 13 of the Medicines Regulation, the NoMA may ban the advertising or impose a fee.
b) Herbal
With respect to alternative products there is a separate Regulation on marketing for alternative treatment of illness (FOR-2003-12-11-1501) with reference to the Alternative treatment Act (LOV-2003-06-27-64) section 8. See further details in the question below.3. What health, advertising, and marketing claims may be made for traditional, herbal, complementary, or alternative products?
See Marketing, Manufacturing, Packaging & Labeling, Advertising questions 7, 17, 19 and 20]a) Traditional Medicine
According to the Regulations on medicines Sections 13-4 and 13-5 advertising for medicines to the general public is only allowed for non-prescription drugs or medicines in packages that are exempt from prescription and when recommended exclusively for illnesses or symptoms that would not normally require examination or treatment by a physician, dentist, veterinarian or marine/fish health biologist. See more detail in Marketing, Manufacturing, Packaging & Labeling, Advertising Question 17.
b) Alternative Products
The marketing of alternative treatment is strictly regulated in its own regulation on marketing of alternative treatment (FOR-2003-12-11-1501). The main rule is that marketing should take place by “a sober and factual description of the nature of the business”. In practice, this means that practitioners must not offer alternative treatment, and in its marketing they cannot use claims that a form of treatment has an effect on specific illnesses or disorders or in other ways design the marketing to give this impression including which diseases / conditions the treatment should work against.
The marketing shall state the name, address, telephone number and other necessary contact information of the practitioner. If the practitioner is a member of a practitioner organization, the name of that organization shall be stated.
Examples of marketing that are allowed are more general descriptions of the conditions in which the forms of treatment can be used. Examples of this would be if it is stated in the marketing that a form of treatment is used for «back and neck pain», «stiff muscles», «fatigue», «laxity» and the like. Also, it can be stated that the form of treatment can be used to prevent or reduce the extent of such generally described conditions or disorders.
In the context of marketing, it will generally not be possible to make or present statements, recommendations or conclusions from professional journals, research institutions, research projects or other sources in connection with the therapist or the individual treatment. The use of such sources with an authoritative mark can easily be perceived by the consumer as assertions of effect, in which case the marketing will be contrary to the regulations.
- As an example of such marketing that would easily be in violation of the regulations may be claims of the type:
- “Research study X indicates that treatment A is effective against suffering / illness ...”, “A research project at university / college Y has shown noticeable improvement in the patient’s complaints using treatment type B ... “,” A study published in specialist journal Z supports previous assumptions that treatment type C will result in faster treatment / cure of diagnosis / disease ... “,” Prolonged use of treatment method D in US hospitals indicate / have shown that the treatment is favorable in relation to diagnosis / illness. »
Similarly, marketing that has received or rendered statements from satisfied customers, user surveys, statements where health professionals favor an alternative form of treatment given to a patient or group of patients can easily give the impression that a form of treatment is effective.
- In principle, such marketing will also be prohibited.
- Examples of such marketing may be statements of the type: “Patients O, P and Q have stated in Weekly A that they have been very satisfied with the use of the treatment X for the disease ...”, “The treatment Y was very effective against my disease ... “,” A user study conducted by the Norwegian practitioner organization for treatment Z shows that a certain percentage of patients registered improvement in the disease / condition B using treatment Ø “,” Physician R states that she has observed a noticeable faster healing / treatment in those of her patients with the disease C who, in addition / instead of school medical treatment, have chosen the alternative form of treatment Y ».
c) Homeopathic
The Medicines Regulation Section 13-17 sets out that advertising for homeopathic medicines for humans and animals registered in accordance with § 3-21, § 3-22 and § 3-22A shall contain only the information set out in § 3-39. This means that labelling and, if appropriate, with packaging for homeopathic medicine registered in accordance with § 3-21, § 3-22 and § 3-22A shall be clearly marked «homeopathic medicine», or «homeopathic medicine for animals».
In addition, only the following information should appear:
- the scientific designation of the stock solution followed by the degree of dilution using symbols as described in the applied pharmacopoeia, cf. § 3-8, letter h). If the homeopathic medicine consists of two or more stock solutions, in addition to the scientific name of the stock solutions, a trade name may be included on the package,
- the name and address of the registration holder;
- the name and address of the manufacturer where he is another registrant;
- method of administration and, if necessary, route of administration,
- the expiry date (month, year);
- pharmaceutical form,
- package size,
- any special precautions regarding the storage of the medicinal product;
- special warnings, if necessary;
- the production batch number;
- registration number;
- “homeopathic medicine - without approved area of use”;
- homeopathic medicine for humans should be marked with a recommendation to the user to seek medical advice if the symptoms persist, and
- if the medicinal product is for animals, the species for which it is intended.
The regulation on medicines Section 13-16 sets out that traditional plant based medicine shall be designed in accordance with the requirements set out in Chapter 13. All advertising for Traditional Plant-based Medicines shall also contain the following statement:
- “Traditional Plant-based Medicines with a Specific Area of Use Based solely on Long-Term Tradition”
4. What are the regulatory requirements for over-the- counter (non-prescription) medications?
See Regulatory, Pricing and Reimbursement Overview questions 2 and 3, and Marketing, Manufacturing, Packaging & Labeling, Advertising questions 1 and 2] for non-OTC in pharmacies.Currently, certain non-prescriptive medicines may also be sold OTC in normally groceries etc, but only if they are registered with the Food surveillance authority and only listed drugs according to the regulation on medicines sold outside the pharmacies (LUA-Regulation, FOR-2003-08-14-1053). In addition there are rules on the placing of the OTC medications and on marketing in the stores etc, that are not pharmacies. There is a list found here updated 23 March 2020 of drugs which may be sold OTC elsewhere than pharmacies.
The Medicines Act limits access to OTC outside pharmacies to merchants and Section 2 of the LUA Regulations requires that the point of sale must be subject to supervision by the Food Safety Authority. In practice, this means that the point of sale must be registered in the Norwegian Food Safety Authority’s registers. The owner of the outlet is obliged to register his business with the Norwegian Food Safety Authority such as kiosk , gas stations and grocery stores.
Companies that sell medicines in accordance with the LUA regulations shall have a specially responsible person for these product groups, cf. section 14.. The company must, on request, document who is particularly responsible. The Norwegian Medicines Agency may impose new requirements on the competence of the individual responsible and there is a fee to be paid to NoMA. The medicine can only be purchased by approved wholesalers. In addition there are requirements concerning minimum stocking, storage, control of sale and marketing, prohibition on advising and only refer to pharmacies, and shipping etc. See [Marketing, Manufacturing, Packaging & Labeling, Advertising, Question 18].
The pharmacies are allowed to sell both non-prescription and prescription drugs OTC but all pharmacies must be registered in the NoMA register and have a license for ownership operation and if applicable production .5. Are there any limitations on locations or channels through which OTC products may be sold?
a) Traditional Medicine See Marketing, Manufacturing, Packaging & Labeling, Advertising Questions 18.In principle, all businesses registered with the Norwegian Food Safety Authority as a “food business” can also sell medicines outside pharmacies. Requirements for the sale are stipulated in the regulation on the marketing of certain non-prescription medicines outside pharmacies (LUA regulations) FOR-2003-08-14-1053.
OCT products shall be stored behind the counter, in a locked cabinet or otherwise physically inaccessible to the point of sale customers. The drugs should only be sold at the request of the customer and delivered by the service of the outlet. Automated dispensing and other dispensing after the customer has delivered a substitute for the drug to the service is equated to dispensing from the service to the extent that the same control tasks are satisfactorily fulfilled.
NoMA establishes a list of medicines that can be placed in self-selection at the point of sale. These drugs should at the point of sale:
- be placed in such a way that they are separate from other goods at the point of sale; and
- placed so that they are not accessible to minors and
- be placed so that they are supervised by the outlet’s operation
The Regulation also regulates the online sale. Outlets that sell drugs over the Internet are obliged to provide NoMA with updated information on the following:
- the address of the place from which the medicines are to be dispensed;
- the time when the sale of medicines over the Internet begins; and
- the address of the site to be used and any other relevant information necessary to identify the site.
The site should contain the following:
- a logo, set by NoMA, on each page of the website, which identifies where the seller of the medicines is established,
- a link to NoMA’s information page on the Internet about the sale of medicines over the Internet, and
- a link from the logo mentioned in letter a) to NoMA’s electronic list of players who are authorized to sell medicines over the Internet
6. What health, advertising, and marketing claims may be made for OTC products?
See Marketing, Manufacturing, Packaging & Labeling, Advertising Questions 17.It follows from the Medicines Regulation (section 13-5) that advertising for medicines to the general public is only allowed when recommended exclusively for illnesses or symptoms that would not normally require examination or treatment by a physician, dentist, veterinarian or marine/ fish health biologist .
Such advertising must not contain material which refers to recommendations from researchers, HCP, or others who, by virtue of their reputation, may encourage the use of medicines. It in addition follows from the LUA Regulation Section 13 that the use of reminders for drugs or other marketing measures aimed at promoting accidental purchases of drugs is prohibited. Advertising for medicines is not allowed in or directly in connection with the outlet’s premises.
7. Can OTC products be marketed or advertised directly to the public?
See Marketing, Manufacturing, Packaging & Labeling, Advertising Questions 17, 19 and 20]Yes, with the limitations mention above. Regulation on OTC sales of certain no prescription medicines outside pharmacies, i.e. LUA regulation. The use of reminder advertisements (reminders) for drugs or other marketing measures aimed at promoting the random purchase of medicines is prohibited, cf. LUA Regulation section 13. Advertising for medicines is not allowed in or directly in connection with the outlet’s premises.
8. What is the mechanism by which a prescription-only product can be converted to an OTC product?
Prescription status is a national concern for drugs in decentralized procedure (“DCP”), mutual recognition procedure (“MRP”) and national procedure (“NP”). In these cases, NoMA determines the drug’s prescription group. Determination of prescription status is based on the Medicines Regulations and Directive 2001/83/EC. Hence, the rules are the same as for the rest of the EU, see here.
9. What are the requirements for the importation of either tradition- al medicines or OTC products?
See Marketing, Manufacturing, Packaging & Labeling, Advertising Questions 7.a) Traditional Medicine and OTC
All businesses engaged in wholesale activities in Norway need an import license for NoMA, regulations on the manufacture and import of medicines (FOR-2004-11-02-1441) including:
- Import (import medicines across the border to Norway from other countries (both EU countries and third countries)
- Procurement (including purchases)
- Storage
- Distribution (transport can be outsourced to contractors who do not have a wholesale license, transport is the responsibility of the client)
- Delivery (including sales)
Exception:
- Manufacturers in the EEA (excluding Norway) who want to take advantage of the opportunity to conduct wholesale business with their own medicines in Norway. These must send a message to the National Medicines Agency.
- Wholesalers with permission issued by another EEA authority. It is assumed that the relevant wholesale activities are covered by the domestic permit. Own storage of medicines requires permission from NoMA. EEA wholesalers who wish to conduct wholesale business in Norway are recommended to use the same reporting scheme as for EEA manufacturers.
- By virtue of its license, pharmacies can import medicines from the EEA area for sale in the pharmacy by prescription or requisition. See regulations on the manufacture and import of medicines (FOR-2004-11-02-1441) Section 3-1, third paragraph.
The application must state
- which drugs and / or pharmaceutical forms are to be manufactured or imported;
- the relevant manufacturing or importing activities;
- the manufacturing process, if applicable, for example, by inactivating viral or non-conventional agents, and
- where the business is to take place
Otherwise, the same requirements (GDP and requirements for, for example, duty of delivery within 24 hours in the wholesale regulation) apply as for other wholesalers, confer Section 4 (FOR-1993-12-21-1219).
b) For Own Use
Both non-prescription (OTC) and prescription medicinal products may be stopped. Even if a consumer has been given a prescription by a Norwegian physician, it does not entitle the consumer to purchase a corresponding medicine from abroad. A product may be considered medicinal in Norway even if it is not considered to be one in the country from which the product is being imported. Illegally imported medicines may be confiscated and destroyed by Norwegian Customs, cf. Section 3-2a of the Regulation on manufacture and import of medicinal products. There are approved Norwegian online pharmacies which send both non-prescription and prescription medicines by post.
Vitamins and minerals are allowed to to be imported if they are intended for personal use, are to be taken orally and are not being marketed as a medical product. Importing vitamins which must be taken by injection is not permitted. In order to import vitamins for resale as dietary supplements, you must contact the Norwegian Food Safety Authority.
Dietary supplements containing vitamins, minerals and herbs can genera-
lly be imported for personal use (see above). However, foreign online stores may offer “dietary supplements” which also contain medicinal substances. Such products may be illegal to import, and they may also be harmful to use. There are many unprofessional companies selling health products.
The regulations applicable to homeopathic medicines are currently subject to review. Until further notice, NoMA has decided to allow private importation of homeopathic medicines (except for injections) if they originate from an EU/EEA country. The list of medicinal substances shows a selection of substances that may be stopped by Norwegian Customs. The list is only advisory and not complete.
Exceptions - substances which will not be stopped
Some substances on the list of medicinal substances can be considered to be medicinal in one product, but not in another. Examples of such substances are:
- betaine
- papain
- bromelain
- alpha lipoic acid
- omega-3 fatty acids
- tryptophan
- caffeine
- melatonin (products that contain more than 1 mg/daily dose is generally medicinal in Norway)
Products containing these substances will normally not be stopped by Norwegian Customs if they are not being marketed as medicinal products.
Additions - substances which will be stopped
The list of medicinal substances is not exhaustive. There are many substances that are not mentioned on the list, and still not allowed for private imports. Examples of such substances are:
- Phenibut
- Cratom
- Huperizine A
- DMAA
- Higenamine
- Hordenine
- Antibiotics
Also from this Legal Handbook
5. Marketing, Manufacturing, Packaging & Labeling, Advertising: Norway
1. What is the authorization process for the marketing of new drugs, biologics, medical devices, over-the-counter medications, and other medicinal products?
See Regulatory, Pricing and Reimbursement Overview, question 3.2. What is the authorization process for the marketing of generic versions of these products?
See Regulatory, Pricing and Reimbursement Overview, question 3. As a practice, the NoMA has on request to state whether a MA has been sought for an active substance. The information that is regularly posted on the Internet is limited to the first time an active substance is sought generically, i.e. applications sought for Art. 10 (1) / 13 (1) (generic application) and pursuant to Art. 10 (3) / 13 (3) (hybrid application) of Directive 2001/83/EC.3. What are the typical fees for marketing approval?
See Regulatory, Pricing and Reimbursement Overview, question 4.Holders of marketing authorization/approvals (i.e. the “MAH”) have to pay a regulatory fee when they apply for marketing authorization. MAHs in the Norwegian market are also liable to pay a supplier tax of 1.0% of turnover.
The fees are in Norwegian kroner (“NOK”).
For Marketing Authorization Applications (“MAA”) in Decentralised Procedure (“DCP”) and Mutual Recognition Procedure (“MRP”) a fee, at time of agreement for Norway to be RMS, has been introduced. If the application subsequently is withdrawn, this fee will not be reimbursed.
For grouped variations, according to Variation Regulation EC 1234/2008, the fee will be equal to the sum of each variation applicable for a fee.
For products intended for MUMS (Minor Use/Minor Species) there is a 50% reduction in the fee. MUMS-status must be clarified with NoMA before submission.
NoMA will invoice the fee on the basis of received application. Please note that we invoice the company that submits the application, should no other receiver be stated in the cover letter. Reference, such as PO-number, must be stated in the cover letter. Payment is due at the latest within 30 days from date of invoice.
4. What is the period of authorization and the renewal needed process?
See Regulatory, Pricing and Reimbursement Overview, question 5. An authorization has a 5 years valid before renewal is needed.5. What are the requirements, if any, for post-approval pharmacovigilance?
Pharmacovigilance is an important tool for ensuring safe and effective drugs. The purpose is to gather information about safety in clinical use and shorten the time until the safety profile of a drug is well known.
- Pharmacovigilance takes place both at national and international level. NoMA is actively contributing to the European Medicines Agency’s Committee for pharmacovigilance, Pharmacovigilance Risk Assessment Committee (PRAC).
The Marketing Authorization Holder (MAH) has the primary responsibility for monitoring
NoMA is responsible for the detection and monitoring of adverse reactions of all medicinal products approved in Norway, but it is still the pharmaceutical company that markets the individual medicine in Norway (MAH) that has primary responsibility for the effect and safety of their medicinal products. The MAH must ensure that it has an appropriate system of pharmacovigilance and risk management in place in order to assume responsibility and liability for their products on the Norwegian market and to ensure that appropriate action may be taken when necessary. In order to fulfil the requirements, the MAH must ensure that all information relevant to the risk-benefit balance of medicinal products is reported to the authorities periodically through Periodic Safety Update Reports (PSUR) and continuously through expedited reporting of Individual Case Safety Reports (ICSR).
Module VIII Post-Authorization Safety Studies (PASS)
NoMA will request protocols, progress reports and final reports from studies the MAH is obliged to perform in accordance with Regulation 726/2004 article 10 a (1)(a) and Directive 2001/83/EU art 21a (b) and 22 a (1), on products:
- for which Norway is the Rapporteur or Co-rapporteur in the centralized procedure,
- for which Norway is the reference member state (RMS) in the mutual recognition procedure (MRP) or decentralized procedure (DCP),
- for which Norway is the Lead Member State for the PSUR Single Assessment (PSUSA),
- approved by the national procedure (NP)
See also the Guideline on good pharmacovigilance practices (GVP) Module VIII Addendum I – Requirements and recommendations for the submission of information on non-interventional post-authorization safety studies (Rev 2)
6. Are foreign marketing authorizations recognized?
Yes, within the EEA/EU and those countries Norway has a Mutual Recognition Agreement which currently is Australia, New Zealand, Canada and Switzerland.
Imports via another EEA country
Medicines produced in third countries and released in an EEA country by a manufacturer with a manufacturer’s authorization from the country’s pharmaceutical authority can be imported into Norway without requiring renewed final control and release in Norway. The qualified person of the importer in the country where the lot is released is responsible for the necessary analyses being carried out, that the lot has not deteriorated during transport and that reference and retention samples are taken.
Each batch of production shall be subject to a complete qualitative analysis, a quantitative analysis of at least all active substances, as well as other controls necessary to document the quality of the medicinal product. The obligation to carry out an analytical check does not include medicinal products for clinical trials and medicines that are exempt from the requirement for MA pursuant to Sections 2-5 and 2-6 of the Medicines Regulation (FOR-2009-12-18-1839).
An importer with a manufacturing authorization can carry out the analysis himself. Alternatively, the importer may purchase the analyses of activities in the EEA area that have a manufacturing authorization for such activities in the EEA country concerned.
An importer is exempted from the requirement for analysis if a MRA has been concluded between Norway and the third country concerned. As mentioned above Norway currently has an MRA agreement with Australia, New Zealand, Canada and Switzerland. The agreement with Canada does not include veterinary vaccines and blood products.
The requirements for testing and release are further described in the Manufacturing Regulation and Guidelines for Good Manufacturing Practices (“GMP”) for Medicines in the EU, Annex 16.
Direct imports from countries outside the EEA
Medicines imported from countries outside the EEA (third countries) shall be subject to full final inspection prior to release for sale in the EEA. The importer must have a manufacturing permit and a qualified person (“QP”) to carry out the necessary checks and release for sale.
The importer’s qualified person is responsible for the product being released being manufactured in accordance with GMP and otherwise satisfying the requirements set out in the MA.
For wholesalers with a wholesale license, a manufacturer’s license is not required for imports from third countries for medicines that are exempt from the MA requirement in accordance with the Medicines Regulations. However, this only applies to imports from countries that are members of the Pharmaceutical Inspection Cooperation Scheme (“PIC/S”) or from countries with which Norway has an MRA agreement in the pharmaceutical field.
7. Are parallel imports of medicines or devices allowed?
Yes, on certain conditions. Parallel import of medicines to Norway occurs when a drug that has a valid MA in an EU / EEA country is imported into Norway and marketed in competition with a similar preparation with a valid MA in Norway.
In order to be able to sell a drug in Norway, the drug must have a MA issued by NoMA.
Medicines normally receive MA on the basis of an application from a drug manufacturer, where the application is enclosed with documentation that the drug is both of good quality and safe and effective to use.
According to Article 11 of the EEA Agreement, medicines legally placed on a national market must flow freely within the internal market. The EEA agreement contains provisions on prohibition of import restrictions, which means, for example, that Norway cannot immediately refuse parallel imports of medicines.
The provisions do not preclude import restrictions which are justified on grounds of protection of human and animal life and health, cf. Article 13 EEA Agreement, parallel importation of medicinal products is thus permitted only where the protection of public health is safeguarded.
In order for a parallel imported drug to be marketed on the Norwegian market, it is required that the drug has a marketing license for parallel import (“PI”), issued by NoMA, cf. Medicines Regulation, Section 3-24. Pursuant to the Medicines Regulations Section 8-4, the MA will lapse if the drug is not marketed within 3 years after the license was issued (sunset clause). A parallel import MA will lapse if the drug, after being marketed in Norway, is no longer marketed here in Norway for three consecutive years.
Parallel import terms
There are no specific provisions on parallel imports in the pharmaceutical legislation. NoMA normally sets the following conditions for parallel imports of medicines to Norway:
- The imported drug must have MA in the exporting country.
- Parallel import of drug can only happen when the same drug (directly imported drug / reference product) has MA in Norway.
- The drug contains the same active substance and has the same therapeutic effect as the directly imported drug / reference product.
- Inequalities between the drugs can be accepted if they have no effect on the therapeutic effect, and imports for other reasons are not questionable on the grounds of the protection of public health.
In each case, NoMA considers whether parallel imports should be allowed.
All information/labelling of medicine and devices must be available in Norwegian also for parallel imported drugs, and the labelling is approved by NoMA.
8. What are the restrictions on marketing practices such as gifts, sponsorships, consultancy agreements, travel and entertainment, or other incentives for healthcare organizations and individual medical practitioners?
a) GiftsThe Medicines Regulation chapter 13 regulates advertisement for pharmaceuticals. Section 13-10 states that when advertising of pharmaceuticals to HCPs it is prohibited to give, offer or promise the HCPs goods, gifts or benefit of monetary value, except where the goods or benefit has insignificant value and in connection with the execution of the HCPs business. However, the Association of the Pharmaceutical Industry in Norway (Nw. Legemiddelindustrien, “LMI”) has adopted Industry Rules which provides more detailed rules related to gifts, hospitality, entertainment etc. Chapter 13 provides a general and absolute prohibition of gifts, which includes inexpensive promotional items such as pens, mouse mats and post-its.
The Norwegian Association for Medtech and Lab (“Melanor”), which organizes approximately 115 medical device companies in Norway, has adopted a Code of Ethics. The Code chapter 8 states that member companies may in some limited situations give equipment of limited educational value, in accordance with Norwegian law. The Ethics Code is in line with the Ethical Code of Medtech Europe.
In addition, the Healthcare Personnel Act (LOV-1999-07-02-64) section 9 provides that HCPs may not accept gifts, commissions or other benefits that are suitable to unduly affect the HCP’s services.
b) HospitalityRegarding hospitality, travels and entertainment, the Medicines Regulation does not provide any specific regulation on the matter outside the general prohibition of advertisement of pharmaceuticals through benefits of monetary value.
The Healthcare Personnel Act section 9 and the accompanying Regulation on gifts to HCPs (FOR-2005-08-29-941) states that covering expenses related to seminars and conferences may constitute gifts. Consequently, HCPs are not allowed to accept hospitality that is intended to influence them in an unduly manner.
The LMI Industry Rules provides a detailed set of rules applicable to all members. The Rules provides that hospitality can be provided for modest events provided with the purpose of updating the HCP’s professional knowledge. Hospitality must be limited to travel, meals and accommodation. The Rules also provides that it is prohibited to finance participation travel or board for HCPs’s attending events abroad which have been organized by third parties.
Melanor’s Code of Ethics provides that member companies can invite HCPs to the companies own events as well as training/education organized by third parties. The Code provides that member companies may not organize events that includes entertainment and other non-professional events. If there are events with educational purpose that also has some limited entertainment, the HCPs shall pay for that part themselves. Member companies may cover reasonable travel and lodging cost, but the hospitality must be subordinate in time and focus to the event’s purpose.
9. How is the manufacturing of medicines and devices regulated and by which agencies?
a) Medicinal ProductsPursuant to the Regulation on production and import of medicines (FOR-2004-11-02-1441) section 2-1 the manufacturing of medicines requires an authorization from NoMA.
In order to obtain a manufacturing authorization, the applicant must file an application containing information concerning:
- What pharmaceuticals or pharmaceutical forms that are to be manufactured;
- specification of what types of manufacturing is intended to take place. Note that the definition of manufacturing in section 12 of the Medicines Act encompass production, packaging, repackaging, labelling, etc.;
- the production process; and
- the location of the manufacturing
In addition the Regulation on production and import of medicines states additional requirements for the manufacturing process., which must be in place upon the date of authorization. This includes, inter alia:
- Have at least one qualified person, as defined in the regulation, that is approved by NoMA available at any time;
- an effective pharmaceutical quality control system;
- staff that are compliant with the legal requirements concerning manufacturing and control;
- having necessary documentation available in case of inspection by NoMA;
- production in accordance with Good Manufacturing Practice as defined by EMA
There are no authorization process required for the production of medical devices under Norwegian law. The manufacturer is, however, responsible for ensuring that the medical devices are compliant with the applicable rules and regulations, see Regulatory, Pricing and Reimbursement Overview question 3.
10. Are local manufacturing requirements compatible with Good Manufacturing Practices (GMPs) as defined by the US Food & Drug Administration (US FDA) and/or the European Medicines Agency (EMA)?
The Norwegian Regulation on manufacturing and import of medicines (FOR-2004-11-02-1441) states that manufacturing shall be in accordance with GMP as defined by European Medicine Agency (“EMA”).
11. What is the inspection regime for manufacturing facilities?
a) MedicinesNoMA conducts regular audits of manufacturing sites to ensure the compliance with the Regulation on manufacturing and import of medicines. NoMA usually provides notification to the manufacturer 2-4 weeks in advance, unless NoMA assesses that it is paramount that the manufacturer is not notified in advance.
The inspectors can require access to all areas that are covered by the manufacturing authorization and demand access to all samples and information/ documents deemed necessary in order to perform the inspection. After the inspection NoMA will prepare a report, usually within 30 days, where the observations regarding compliance with the applicable regulations are noted. Non-compliance are separated into three categories:
- Critical non-compliance issues requires immediate correction. The manufacturer must document that the issue is rectified within a deadline provided by NoMA (maximum 1 month)
- Major non-compliance issues. The manufacturer is given 75 days after last inspection date to provide documentation that the non-compliance issue is rectified.
- Other non-compliance issues. The manufacturer is given 6 months after NoMA’s report is provided to provide documentation that the non-compliance issue is rectified.
NoMA is responsible for conducting audits/inspections of the manufacturing process, and may require access to production sites, documentation, equipment etc. to the extent it is necessary to perform its role as the supervisory authority.
12. Are manufacturing facilities open for inspection by foreign inspectors or third-party inspectors as authorized by the FDA/EMA?
Inspection at production sites for medicinal products can only be performed by NoMA pursuant to Section 4-1 in the Regulation on the manufacture and import of pharmaceuticals.
13. What are the requirements for storage, packaging, and handling of medicines and devices and their constituent components?
a) MedicinesSee the European Pharmacopoeia (“Ph. Eur.”) 1.4 “Monographs” under “Storage” and Ph. Eur. 3.2. “Containers” available here. Medicines should be stored in containers that are clearly signed and that protect against contamination with other substances and dust. The storage container must not affect the medicine in such a way that the prescribed requirements for the medicine cannot be fulfilled.
Storage in tightly closed container
shall be taken so that the medicinal product is adequately protected against weathering, against evaporation and from free access to moisture, oxygen or carbon dioxide by the air.
Storage in airtight closed container
shall be carried out so that gas exchange with the surroundings is completely excluded.
Storage in sealed container
shall be made in a container which is closed by the fusion of the container material.
Storage in a tamper-proof container
shall be made in a container with a closure device which irreversibly indicates whether the container has been opened.
Storage in child-proof container
should be made in a container with a closure device that prevents children from opening the container.
Desiccant storage
should be made in tightly closed container or cupboard with suitable desiccant.
Storage protected from light
shall be carried out either in a place which is inaccessible to light, or in a container or gasket which is impervious or only slightly permeable to light, e.g. dark brown glass.
Storage excluded from light
shall be carried in a container or package which is impervious to light.
Radioactive drugs
shall be stored as specified under “Radiopharmaceutical preparations” (“Ph. Eur.”) and otherwise in accordance with applicable guidelines from the Directorate of Radiation Protection and Nuclear Safety.
b) Medical DevicesAccording to the Regulation on medical equipment storage must be compliant with the specifications as provided by the producer which is necessary for the device to function as the producer intended , cf. Section 2-7.
14. What information must be included in medicine and device labeling?
a) Medicinal ProductsThe national labelling guidelines are based on Sections 3-29 to 3-41 of the Medicines Regulations and apply to both human and veterinary medicines. The outer packaging of the medicinal product or, if it does not exist, its inner packaging, must be provided with the following information:
- the name of the medicinal product followed by strength and form of the medicinal product and, if appropriate, an indication of whether the medicinal product is intended for infants, children or adults; If the preparation contains up to three active substances, a generic name must be given. If no such name is found, the commonly used term must be given. If the application applies to a veterinary medicinal product, a generic name must be given if the medicinal product contains only one active substance and if the medicinal product’s name is a trade name. The trade name shall not be confused with the generic name, nor shall it be capable of giving rise to confusion with other medicinal products or giving grounds for incorrect use,
- the quantitative and qualitative composition of all the active substances of the medicinal product, as per dosage unit, per volume unit or weight unit, depending on the drug form,
- pharmaceutical form and content by weight, volume or number of doses;
- a list of the excipients that have known effects in accordance with the EU’s detailed guidelines on excipients. However, if the drug is for parenteral, topical or eye use, all excipients should be listed,
- administration,
- a warning that the medicine should be kept out of the reach of children;
- a special warning if required for the medicinal product concerned;
- the expiry date in plain text (month / year);
- any special precautions for storage;
- any special precautions for the disposal of unused medicinal products or waste, as well as a reference to existing suitable collection systems;
- the name and address of the MA holder and, where appropriate, the name of the agent where appointed;
- the MA number;
- the lot number of the production lot;
- instructions for use of the medicinal product, if the medicinal product is non-prescription, and
- Nordic item number.
In addition to what follows from the first paragraph, the Norwegian Medicines Agency may require that the drug be labelled with information on;
- the price of the medicinal product;
- conditions for reimbursement from the National Insurance Scheme;
- the status of delivery to the user; and
- identification and confirmation of authenticity.
Prescription drugs must have a safety device to be used to identify individual packages for authentication. Medicines that are not subject to a prescription should only have the safety device as mentioned in the fourth paragraph first sentence when the medicinal product appears on a list established by the European Commission. (Section 3-29 of the Medicine Regulation) Medicinal product for human outer packaging shall be affixed to the name of the medicinal product indicated in Braille and strength if the medicinal product is found in several strengths.
Also the inner package must have the information described above unless except due to the small size. The minimum information shall then be according to Section 3-36:
- the name of the medicinal product, as provided in § 3-29 (a);
- administration,
- strengthening, if necessary;
- expiration date,
- the lot number of the production party;
- content by weight, volume or number of doses; and
- the label “for animals” if the medicinal product is intended for use in animals
All Information must be provided in Norwegian, be easily readable, clearly understandable and should not be possible to delete.
Drug packages must be designed in such a way as to reduce the risk of confusion and misuse. The final packaging design is approved by NoMA. NoMA may require that drug packages be equipped with graphic elements, including the use of colours.
b) Medical DevicesThe CE-mark must be included.
Equipment shall be provided with, or enclosed with, information necessary for the safe use of the equipment, taking into account user education and knowledge.
The manufacturer and the product must be identifiable. For equipment imported into the EEA area for marketing and distribution, the person responsible for the EEA area must be stated.
Marking and operating instructions etc. for medical equipment and accessories for use in Norway shall be in Norwegian. See new Medical Devices Regulation, section 8
15. What additional information may be included in labeling and packaging?
a) Traditional Medicines
Outer packaging may have symbols or pictograms to explain certain particulars mentioned in Section 3-29 and other particulars which are compatible with the approved preparation and which may serve as health information, except for any item with the characteristic of commercial/marketing.
Packaging of medicinal products shall contain packing information containing information to the user, unless all required information is provided on the inner or outer packaging.
Pursuant to the regulation on medicines from pharmacies (FOR-1998-04-27-455) Section 12-1 , it must be ensured, when dispensing a drug, that it is adequately labelled to ensure:
- identification of the preparation;
- manufacturer identification;
- proper storage;
- proper use
When dispensing pharmacy produced medicinal products and medicinal products in packaging other than the manufacturer’s original, the following shall be applied to the medicinal product’s packaging:
- the name of the medicinal product;
- the potency of the drug;
- package size;
- the manufacturer of the drug;
- the manufacturer’s production number;
- MA holder;
- complete declaration according to original marking. Such a declaration can still be omitted if the drug name is unambiguous;
- control number, if the medicinal product is manufactured in a pharmacy;
- the expiration date.
The original expiry date can only be transferred if you are assured that the same shelf life applies in new packaging. The original expiration date must always be in the package documentation.
As a general rule, non-prescription drugs should also be applied to the use or instructions for use and the name of the pharmacy.
A copy of the package leaflet should be enclosed if present in the original packaging.
Additional warnings
If the standard label does not already appear, the following warnings should be applied to the drug before delivery:
- All medicines should be marked “Keep out of the reach of children”.
- Medicines that may impair the ability to drive motor vehicles or carry out risky work, oral medicinal products with ethanol content greater than 10% by weight and other medicinal products in accordance with the National Medicines Agency’s regulations shall be marked with a warning triangle. The design of the warning triangle is determined by NoMA. If the prescriber indicates on the prescription that a drug may impair the ability to drive a motor vehicle or perform risky work, the drug shall be marked with a warning triangle.
- If the retention period for eggs, milk, honey or slaughter is specified on the prescription from a veterinarian or fish health biologist, the retention period shall be applied to the drug.
- If the time limit for starting the competition is specified on the prescription of the veterinarian, the start date shall be applied to the drug.
- Corrosive substances to be used as medicines shall be marked “Corrosive”.
- Flammable and explosive substances shall be labelled in accordance with regulations on flammable and explosive products.
- Pharmaceuticals containing sodium bicarbonate medicinal products, which are dispensed without a prescription, shall be marked with the following warning: “The preparation contains sodium bicarbonate (sodium). In some, this can be harmful, especially in long-term use, or when the preparation is taken at higher doses than recommended.”
- Medicinal products with bismuth content leading to the intake of 1 g or more bismuth salt per day, which are dispensed without a prescription, shall be accompanied by the following text: “This preparation should not be used continuously for a long period of time. If the complaints persist for more than 3 weeks, you should seek medical attention.”
There are detailed regulations in terms of labelling requirements both in the Medicine Regulation (FOR-2009-12-18-1839) Sections 3-29 to 3-41.
b) Medicine without MA
If a medicine does not have MA in Norway it must be added “Preparation for approval exemption. This preparation is not commonly available in Norway. (Available on special application)”
c) Herbal and Homeopathic etc.
Homeopathic and anthroposophic preparations, herbs and herbal preparations and other similar preparations that are dispensed without a prescription shall be applied to the following text: “The medical effect of this preparation has not been assessed”16. What items may not be included in labeling and packaging?
It is not permitted to enclose advertising for Medicines in drug packages beyond the approved package insert. It is not allowed to associate advertising with objects, gifts, prizes or some other kind of reward. Distribution of free drug samples to the public is not allowed.
17. What are the restrictions and requirements for the marketing and advertising of medicines and devices?
There are several restrictions both to the marketing content and where it may be marketed. There is a distinction to be made between the general public and health personnel.
According to the Medicines Regulation Sections 13-5 and 13-6 advertising for medicines to the general public is only allowed for drugs or medicines which is recommended exclusively for illnesses or symptoms that would not normally require examination or treatment by a physician, dentist, veterinarian or marine/ fish health biologist .
Advertising to the public is not permitted for prescription drugs and for drugs containing substances that are classified in accordance with international conventions on psychotropic and narcotic drugs.
The prohibition does not apply to vaccination campaigns that are launched by the industry and which are approved by the authorities.
In advertising to the general public it is not allowed to mention serious illnesses such as, tuberculosis, sexually transmitted diseases, cancer or other tumour diseases, chronic insomnia, diabetes or other metabolic disorders.
Distribution of free drug samples to the public is not allowed for the object of marketing.
Advertising to the public must always be made so that it appears clearly that it is advertisement and that the drug being advertised is clearly identified. The following information should always be included in advertising to the public.
- the name of the medicinal product and the name of the active substance (common name)
- information necessary for the correct use of the medicinal product, including its use and important precautions / warnings. For veterinary medicinal products, which animal species are included, and
- recommendation to the user to read the package and the package leaflet carefully.
Advertising to the public must not:
- give the impression that a medical consultation by a physician or other HCPs’ is superfluous, or to undergo a surgery, by offering a diagnosis or to recommend treatment through correspondence;
- imply that healing by means of the drug is guaranteed or claim that no possible side effects are present;
- claim that the drug is equivalent or better than other treatment or drug;
- claim that health may improve if you take the medicine;
- Claim that health may be impaired if you do not take the medicine, except for vaccination campaigns;
- be directed exclusively or mainly towards children;
- refer to the advice of health professionals or scientists, or persons who is neither a scientist or health professional but due to their reputation may promote the of the use of the drug;
- imply that the drug is a food, cosmetic or other common commodity;
- imply that the drug’s safety or efficacy is due to the fact that it is from nature;
- describe illness stories that may lead to uncertain or incorrect diagnosis;
- point to claims of healing in an undue or deceptive manner, or;
- Use visual description of changes in the human body, which is due to illness or injury, or visual description of the medicines effect on the human body or parts of it, in an undue or deceptive manner.
18. Where can medicines and devices be sold or delivered? Can medicines and devices be sold or delivered via post?
Generally, prescription drugs can only be sold by authorized pharmacies, or physicians may in some limited situations sell prescription drugs directly to patients, but generally only deliver them as a part of their treatment when patients are getting treatment in healthcare institutions, cf. Regulation on handling of medicines for businesses and health professionals providing health care (FOR-2008-04-03-320).
Prescription drugs can be ordered online from authorized web-based pharmacies and delivered per post or picked up at stores as long as the authorized pharmacy ensures that the relevant medicine is packed and stored in a secure manner and that the post service has sufficient routines of tracking and delivery of the medicines.
In principle, all businesses registered with the Norwegian Food Safety Authority as a “food business” can also sell certain non-prescription medicines outside pharmacies. Requirements for the sale are stipulated in the regulations on the marketing of certain non-prescription medicines outside pharmacies (the LUA regulation, FOR-2003-08-14-1053). NoMA publishes a list over OTC products that can be sold outside pharmacies, available here.
OCT products shall be stored behind the counter, in a locked cabinet or otherwise physically inaccessible to the point of sale customers. The drugs should only be sold at the request of the customer and delivered by the service of the outlet. Automated dispensing and other dispensing after the customer has delivered a substitute for the drug to the service is equated to dispensing from the service to the extent that the same control tasks are satisfactorily fulfilled.
NoMA establishes a list of medicines that can be placed in self-selection at the point of sale. These drugs should at the point of sale:
- be placed in such a way that they are separate from other goods at the point of sale;
- placed so that they are not accessible to minors; and
- be placed so that they are supervised by the outlet’s operation.
The Regulation also regulates online sale. Outlets that sell drugs over the Internet are obliged to provide the State Medicines Agency with updated information on the following:
- the address of the place from which the medicines are to be dispensed;
- the time when the sale of medicines over the Internet begins; and
- the address of the site to be used and any other relevant information necessary to identify the site.
The site should contain the following:
- a logo, set by NoMA, on each page of the website, which identifies where the seller of the medicines is established;
- a link to NoMA’s information page on the Internet about the sale of medicines over the Internet; and
- a link from the logo mentioned in letter a) to the State Medicines Agency’s electronic list of players who are authorized to sell medicines over the Internet.
19. What are the restrictions and requirements for electronic marketing and advertising via email, by internet, social media, and other channels?
The general rules for marketing in section 13 of the Medicines Regulation also applies for advertising on the internet, social media and other online channels. According to guidelines from NoMA, the landing page of pharmaceutical companies’ websites shall be neutral with general company information. In addition there shall be a clear distinction between pages available for the public and pages available for HCPs.
The distinction between advertisement directed at the general public and HCPs, is of extra importance in online marketing, since most websites can be accessed by the general public. Consequently, the LMI Industry Rules provides that online advertisement for prescription drugs shall only be available on pages clearly marked as HCP only.
20. May medicines and devices be advertised or sold directly to consumers?
Prescription drugs may only be marketed to HCPs, see above [Questions 17 and 19]. Non-prescription drugs can be marketed directly at consumers, see above in section [Questions 9 and 19] .Prescription drugs may be sold directly to patients by authorized pharmacies after the patient has obtained a prescription from a HCP.
Pursuant to the Medicines Regulation section 7-4, NoMA may restrict the delivery of prescription drugs. In the assessment of whether restrictions should be in place, special consideration shall be given to whether the medicine:
- Due to its pharmaceutical or medicinal properties, its novelty, or due to public health, should be limited to treatment in hospitals only
- Is intended to be used for the treatment of diseases that has to be diagnosed at hospitals;
- Is intended to be used at polyclinical patients, where control and effect requires HCP guidance at the start and during the treatment
Non-prescription drugs can be sold directly to consumers, in accordance with the LUA regulation, see section 18 above.
21. How is compliance monitored?
Both by NoMA and the Consumers Authority (Nw. Forbrukertilsynet) for alternative medicine monitor compliance.
NoMa’s task is to monitor the marketing of medicines, cf. the Medicine regulations Section 13-10. NoMA does not conduct a systematic review of all advertising and the case processing is largely based on complaints submitted.
22. What are the potential penalties for noncompliance?
According to the Pharmaceutical Act, violations of any provision therein may lead to fines and imprisonment from 3 months to 2 years, cf. Section 31, in addition to the fact that the commercial is removed and there may be a prohibition for that medicine of a shorter or longer period.
Also from this Legal Handbook
6. Preclinical and Clinical Trial Requirements: Norway
1. Are clinical trials required to be conducted locally as a condition (stated or implicit) for marketing approval?
See [Regulatory, Pricing and Reimbursement Overview, Section 3 b)]; new medical products must undergo an evaluation of quality. In order to obtain a MA, the pharmaceutical company has to submit sufficient data regarding the quality of the medical product.Clinical documentation, including results from clinical trials, is required as a part of an application for MA.
There is however not a requirement that the clinical trials must be conducted locally; but rather the requirement is that it can be documented that the clinical trial fulfils both research ethical standards/requirements and requirements for good clinical research practice under the Directive 2001/20/EC. Thus, if the clinical trial has been conducted outside the EEA, documentation of fulfilment of these requirement has to be submitted as a part of the application for marketing approval.
2. How are clinical trials funded?
There are several alternatives for financing a clinical trial. Usually clinical trials would not be funded as a part of the ordinary healthcare financial mechanism, but rather through regional, national or international research funds or funded and initiated by private industry.
It is required that the sponsor is seated or represented by an agent by proxy within the EEA. In the latter case the proxy must be documented to NoMA.
The sponsor shall ensure that the trial product/composition with possible associated equipment is made available for free.
3. What are the requirements for preclinical and clinical trial protocols? Who must approve the protocols?
A preapproval is required before the commencement of a clinical trial.
Clinical trials can only be initiated if there is a prior approval from the Ethics Committee, and NoMA does not object to the clinical trial. Thus, the protocol is subject to the assessment and approval of both the Ethics Committee and NoMA.
In examining the application, the Ethics Committee shall in particular consider:
- the relevance and design of the clinical trial;
- whether the estimated risk and disadvantage has been weighed against the benefit of the individual subject and other current and future patients, and whether the conclusion is justified;
- the protocol;
- the suitability of the examiner and the other staff; the investigator’s brochure;
- the suitability of the test site;
- the relevance and completeness of the consent form and the information process related to obtaining informed consent;
- the justification for research on persons who are unable to give informed consent;
- the provisions for compensation or compensation if a subject suffers injury or dies as a result of a clinical trial;
- insurance or allowances to cover the liability of the examiner and sponsor;
- the size and the detailed rules for the payment of any fees or compensation to the examiners and subjects;
- the relevant clauses in any intended contract between sponsor and testing site; and
- how the subjects are recruited.
4. What are the requirements for consent by participants in clinical trials?
Before the commencement of a clinical trial, the participant/test subject shall be informed with regard to the purpose of the test, the benefit and risk associated with the trial participant’s participation, the conditions for conducting the trial and that the test subject may withdraw from the trial at any time.
Before the clinical trial is initiated, the test subject must give his / her (informed) consent to participate in the trial. Thus, the consent shall be given after the required information has been provided / received. If written consent cannot be given, the consent may be given orally. Oral consent must however be attested by an independent witness.
A consent to participate in a clinical trial may be revoked at any time. Patient data and biological material collected until the consent is recalled will be included as study data, but no further data will be collected.
5. May participants in clinical trials be compensated?
Compensation is neither prohibited, nor – similar to international guidelines – directly regulated in the national rules.
The size and the detailed rules for the payment of any fees or compensation to the examiners and participants is, as set out under question 18 above, one of the elements to be considered by the Ethics Committee.
Generally the participant is compensated for travel expenses and if applicable the time spent, (lost income). Any compensation exceeding coverage of the participant’s costs is generally limited. The approach is restrictive, as it is considered from a medical ethical point of view; the compensation should not induce the participant to be more willing to participate and/or continue to participate than without the compensation.
Patients participating in clinical trials may also be entitled to have travel expenses covered provided that the clinical study has been approved by the health enterprise. The clinical trial is then considered as medical treatment and travel expenses are covered according to current rules.
6. How are participants in clinical trials protected and indemnified against any harm that arises as a result of participation in the trial?
The sponsor is obliged to insure the test persons participating in the test satisfactorily against any damage that may occur during the test. As set out in the Product Liability Act, provides a special regulation for damages to natural persons caused by pharmaceuticals, also during trials (e.g. clinical trials).Also from this Legal Handbook
7. Regulatory, Pricing and Reimbursement Overview: Norway
1. What are the regulatory authorities with jurisdiction over drugs, biologicals, and medical devices in your country?
The Ministry of Health and Care Services (nw. Helse-og omsorgsdepartementet, “HOD”) is the legislative authority. The Norwegian Medicines Agency (nw. Statens legemiddelverk – “NoMA”), a subordinate to HOD; is the national authority vested with jurisdiction over both medicinal products and the regulation and monitoring of medical devices. NoMA also is responsible for certain aspects regarding the regulation of non-prescription drugs, such as marketing authorization/approvals, promotion etc.
The Norwegian Health Economics Administration (nw. Helseøkonomi-forvaltningen, “HELFO”) decides on reimbursement for individual patients for where there is no general reimbursement or indication is not covered by general reimbursement.
2. What is the regulatory framework for the authorization, pricing, and reimbursement of drugs, biologicals, and medical devices?
a) AuthorizationThe Medicines Act (LOV-1992-12-04-132) and associated regulations such as the Medicines Regulation (FOR-2009-12-18-1839) set forth the main regulatory framework for the authorization of medicines. The Medicines Act and associated regulations implement the corresponding EU legislation, including Directive 2001/83/EC and Regulation 726/2004.
The regulatory framework regarding authorization of medical devices can, as a starting point, be found in the Medical Devices Act (LOV-1995-01-12-6) and the Medical Devices Regulation (FOR-2005-12-15-1690), implementing the corresponding EU legislation, Directive 90/385/EC, Directive 93/42/EC and 98/79/EC.
However, as of 26 May 2021 a new Act on medical devices must be taken into account, the new Medical Devices Act (LOV-2020-05-07-37) and the new Medical Devices Regulation (FOR-2021-05-09-1476), implementing the EU regulation; Regulation (EU) 2017/745, which replaces Directives 90/385/EC, 93/42/EC.
The regulatory framework regarding authorization on in vitro diagnostic medical devices is still found in the Medical Devices Act (LOV-1995-01-12-6) and the Temporary Medical Devices Regulation (FOR-2005-12-15-1690). This because the EU Directive 98/79 will be will be replaced by Regulation (EU) 2017/746 as of 26 May 2022, cf. Regulation (EU) 2017/745 article 100. As of 22 May 2022 the Regulation (EU) 2017/746 regarding in vitro diagnostic medical devices will then be implemented through legislative acts into the new Medical Devices Act (LOV-2020-05-07-37) and the new Medical Devices Regulation (FOR-2021-05-09-1476).
b) PricingAll registered, prescription-only medicines for humans must have a maximum price, set by NoMA before they can be marketed in Norway, pursuant to chapter 12 of the Medicines Regulation. The market authorization-holder (“MAH”) must apply for a maximum price. The maximum price consists of two elements; maximum pharmacy purchase price (“PPP”) and maximum pharmacy retail price (“PRP”). The PPP is decided based on several factors:
- International price comparisons. Prices in other EEA countries save as the main basis for determining the PPP. The price in other EEA countries is set as the mean of the three lowest market prices of in a selection of relevant EEA countries. The current reference countries are: Sweden, Finland, Denmark, Germany, UK, Netherlands, Austria, Belgium and Ireland.
- Price of comparable medicines including biosimilars and generics
- Production costs can be taken into consideration in special cases
PRP is decided by adding PPP and a maximal profit for the pharmacy. The maximum profit for prescription drugs are based on the following criteria:
- 2.0% add-on from the PPP
- NOK 29.00 add-on per package
- 0.5% add-on from the PPP if the prescription medicine requires cooling
- NOK 19.00 add-on per package for A/B-preparations. A and B preparations are medicines that are addictive, and thus requires specific prescriptions and personal ID prior to issuing. A preparations are the strongest, and includes morphine and other opiates. B preparations are addictive and includes e.g. Valium and sleeping pills.
In addition, after the patent protection and, if applicable, supplementary protection certificates has expired, medicines are subject to a so called “price step model” price reduction. The purpose is to reduce the cost of pharmaceuticals. The “price step model” entails that the price is reduced by a percentage of the original medicines maximal PPP. The PPP is reduced in two or three steps. The first step commence when there is generic competition on the market, while the second commence six months later. The third step commence at the earliest 12 months after commencement of the second step. The size of the price reduction depends on whether the original drug had an annual turnover of above 100 000 000 in a 12 month period within the two years prior to generic competition. The following table illustrates the “price step model”:
Turnover prior to generic competition |
First step (immediate after generic competition) |
Second step (6 months after generic competition) |
Third step (earliest after 18 months after generic competition) |
Below 100 MNOK |
35% |
59% |
Turnover > 15 MNOK. 69% Turnover > 30 MNOK. 88% |
Above 100 MNOK |
35% |
81% | Turnover > 100 MNOK. 90% |
Prices of non-prescription drugs and medical devices are generally set without restrictions.
In order to be listed on the Blue Prescription reimbursement scheme, the manufacturer (or importer) of medical devices has to file an application to HELFO, (see question 2 c below). As a part of the application process the manufacturer and HELFO agrees on a max net reimbursement price for the product in question.
c) ReimbursementIn Norway, prescription medicines are financed by the government through:
- Blue prescriptions: the reimbursable prescription scheme,
- H-prescriptions: regional health authorities and medicines used in hospitals, or
- White prescriptions: by the patients through out-of-pocket payments from the patients .
The Blue Prescription Regulation (FOR-2007-06-28-814) entails that the Government, through the National Insurance Scheme, covers large portions of the costs of medicines, medical supplies such as medical devices, necessary for the treatment of serious illnesses or other risk factors that are likely to cause or intensify serious illness and where there is a need or risk of recurring treatment over a prolonged time.
Pursuant to the Blue Prescription Regulation section 2 some medicines for specific treatments are pre-approved for reimbursements. These can be found on the reimbursement list. Medicines that are not pre-approved for reimbursements, can be reimbursed based on individual application and only for long term treatment, cf. the Blue Prescription Regulation section 3. In addition, medicines used to treat serious contagious diseases can be reimbursed under the Blue Prescription Regulation. HELFO covers 61% of the costs of medicines under the Blue Prescription scheme, and the patient 39%, except in the case of contagious diseases and some other limited exceptions where the reimbursement is 100%.
Some medical devices for certain diseases are also covered by the Blue Prescription scheme, cf. the Blue Prescription Regulation section 5. HELFO updates a list of medical devices covered at least four times a year. It is the supplier of the medical device in question that applies to HELFO to have their product listed under the Blue Prescription Scheme.
The regional health authorities (hospitals) may reimburse 100% of costs of prescriptions for very expensive medicines intended for long term treatment (H-prescriptions). Examples of diseases where prescription drugs can be covered by H-prescriptions are Crohns Disease, Bechterevs Disease and some cancer treatments.
White prescriptions are usually paid by the patient itself. In some limited situations the state may reimburse costs for this category of medicines, such as medicines for IVF-treatments and contraceptives for women between 16 and 22 years.
In addition there is a maximum cost scheme for health services, which entails that if a patient has reached the maximum cost within the calendar year, any additional out-of-pocket expenses are reimbursed by the National Insurance Scheme.
From 1 January 2021 there is now only one threshold group, as opposed to before where there was two threshold groups of maximum costs. The threshold is in 2021 at the maximum cost of NOK 2460.
The maximum cost scheme covers expenses from:
- Physicians visits
- Psychologists
- Medicines, foodstuffs and medical devices covered by the blue prescription scheme
- Hospital
- X-rays and laboratory testing
- Treatment at physiotherapists
- Some types of dental care
- Stay at authorized clinics
- Treatment travels abroad organized by Oslo University Hospital
3. What are the steps to obtaining authorization to develop, test, and market a product?
a) Medicinal ProductsNew medicinal products must undergo an evaluation of their quality, safety and efficiency prior to being placed on the Norwegian market. The process is mainly regulated by the Medicines Regulation and the Norwegian Regulation on clinical trials of medicinal products for human use (FOR 2009-10-30-1321), which incorporates Directive 2001/20/EC. Regulation (EU) No 536/2014 on clinical trials on medicinal products for human use. Directive 2001/20/EC has been implemented in Norway in Regulation (2017-01-12-36) which is in turn is implemented in the Medicines Regulation (Section 15-6a). This section is set to enter into force in December 2021. The process of evaluation of new medicinal products is monitored by NoMA.
The main steps are the following:
- Pre-clinical tests: Not regulated under the medicinal product regulatory framework.
- Clinical trials: The investigational medicinal product is tested on human beings. This is subject to regulatory and ethical review in accordance with the procedures of clinical trials in Regulation on clinical trials of medicinal products for human use.
- Marketing authorization application: Once the clinical trial is finished; i.e. the pharmaceutical company has gathered sufficient data regarding the medicinal products quality, safety and efficiency it can include all the relevant data and use this to file an application for a marketing authorization/approval (“MA”) to either NoMA or the European Medicines Agency (“EMA”)
The pharmaceutical company can put the medicinal product on the market once it (1) has obtained a MA from either NoMA or EMA and (2), if a prescription-only medicine; a PPP and PRP has been set.
b) Medical DevicesA prior authorization from NoMA is not necessary before putting medical devices on the market in Norway. The manufacturer is responsible for ensuring that the medical devices is complaint with the requirements of the relevant regulation, i.e. the Medical Devices Act and the Medical Devices Regulation.
All medical devices require a CE mark to be placed on the Norwegian marked. In order to affix a CE mark, the manufacturer must conduct a conformity assessment. For Class 1 devices, the manufacturer drafts a CE declaration of conformity after having verified compliance with the applicable requirements. For Class Is (sterile), Im (measuring device), IIa, IIb, or III devices, the manufacturer must involve a Notified Body; a private legal entity designated by NoMA to exercise conformity assessment procedures. It is the Notified Body who issues the declaration of conformity required for the manufacturer to affix the CE mark.
If the manufacturer (or EU/EEA authorized representative) is established in Norway, it must register the medical device in the Norwegian Register for medical devices.
4. What are the approximate fees for each authorization?
The fees for applying for an MA of a medicinal product varies depending on the procedure, the type of medicinal product, presentation and other factors. The fees are available on NoMA’s website, and the current price for some relevant categories (per 1 January 2021):
- 433 697 NOK (42 410 EUR, conversion per 23 May 2021) for national applications for complete dossier/well established use (WEU)/fixed combinations
- 108 425 NOK (10 602 EUR per 23 May 2021) for DCP (Decentrialized Procedure) application where Norway is CMS (Concerned Member State)
- 108 425 NOK (10 602 EUR per 23 May 2021) for MRP (Mutual Recognition Procedure where Norway is CMS.
In addition MAHs are also liable to pay a supplier tax of 1.0% annual turnover. We recommend visiting NoMA’s website for a full list over regulatory fees and supplier taxes, available here.
5. For how long are marketing authorizations/registrations valid? How are marketing authorizations/registrations renewed?
a) Medicinal ProductsThe initial MA for a medicinal product has a duration of 5 years. Once renewed after the initial 5 year period, the marketing authorization is valid for an unlimited time period unless NoMA, on justified grounds, requires one additional five-year renewal period.
The renewal application should contain a consolidated version of the dossier filed with the original application, in order to enable a new assessment of risk/benefit for the medicinal product. The renewal application shall be submitted to NoMA latest 9 months prior to the end of the five year period. The renewal application can also be submitted earlier than 9 months after agreement with NoMA.
b) Medical DevicesFor medical devices, once the manufacturer has obtained the CE mark, and if the manufacturer (or EU/EEA authorized representative) has registered the device in the Norwegian Register for medical devices, the device can be placed on the market, without restrictions. However, the declaration of conformity issued by the Notified Body for the CE mark has a maximum duration of 5 years, but can be renewed for additional 5 years periods.
6. How does the authorization process differ between brandname products and generic products? Are there differences for local manufacturers versus foreign-owned manufacturers?
Original medicinal products must be approved through full applications. Full applications requires the market authorization holder to submit full pre-clinical test and clinical trial data (complete dossiers).
A company may obtain MA for generic medicinal products through a simplified procedure, pursuant to the Medicines Regulation section 3-9. The applicant may document that the medicinal product is of the same qualitative and quantitative composition and the same pharmaceutical form of a reference medicinal product that has a MA within the EEA. The application can first be filed 8 years after the reference medicinal product obtained MA within EU/EEA, and the generic product may first be placed on the market 10 years after the reference medicinal product’s MA cf. The Medicines Regulation section 3-10 to 3-11.
For medicinal products that are similar to a reference medicinal product, but cannot meet the criteria of “generic” due to differences in raw materials or in production process (“biosimilars”), it is necessary to conduct comparative quality studies, comparative non-clinical studies and comparative clinical studies.
The procedure to obtain MA does not differ between Norwegian and foreign applicants.
7. How are combination products (drug + drug, drug + biologic, drug + device, biologic + device, drug + biologic + device) regulated?
Pursuant to the Medicines Regulation section 3-13, medicines consisting of combinations of active ingredients that already is used in medicines with MA, only need to submit pre-clinical and clinical data for combination of active ingredients, not for the individual active ingredient.
Combination of medicines and medical devices may be regulated either as a medicinal product or as medicinal products and a medical device. This assessment must be performed on a case-by-case basis.
NoMA can offer guidance on the matter, but also refers to the European Commission guidelines available here.
8. How is compliance with regulations monitored and evaluated? Is the regulatory regime comparable with the U.S. Food and Drug Administration or the European Medicines Agency expectations and requirements?
NoMA is responsible of monitoring compliance with the applicable rules and regulations. NoMA may also conduct site inspection and require samples of medicines. See also Marketing, Manufacturing, Packaging & Labeling, Advertising, question 11. The regulatory regime is in line and compliant with European Medicines Agency expectations and requirements.9. What is the potential range of penalties for noncompliance?
NoMA has broad enforcement powers and may issue administrative fines, as well as revoke and suspend MAs and/or licenses.
10. Is there a national healthcare system? If so, how is it administered and funded?
The Norwegian healthcare system is founded on principles of universal access, decentralization and free choice of provider.
The healthcare system is financed by taxation, together with employer contributions and out-of-pocket payments from patients (co-payment). All residents (if a person’s intended (legal) stay is for at least 12 months) or people working in Norway are as a general rule mandatory members of the National Insurance Scheme (nw. folketrygden). The National Insurance Scheme is managed by the HELFO.
The provision of primary health care is decentralized at municipal level, while specialist care is managed centrally. Most hospitals in Norway are public. The small number of privately owned hospitals are for the most part funded publicly.
There is limited private medical insurance.
11. How does the government (or public) healthcare system function with private sector healthcare?
As mentioned above [Question 10], a fundamental principle of the Norwegian healthcare system is the free choice of provider.12. Are prices of drugs and devices regulated and, if so, how?
See above, [Question 2 b) and c)] for further elaboration on the pricing and reimbursement of drugs and medical devices in Norway.13. How are the drugs and devices used by patients paid for? What roles do public and private payers play?
In Norway, prescription medicines are financed by the government (which again is financed through taxation) through the reimbursable prescription scheme (blue prescriptions), regional health authorities (H-prescriptions and medicines used in hospitals), or by the patients through out-of-pocket payments from the patients (white prescriptions). See above [Question 2 c)] for further elaboration on this matter.
14. Who dispenses drugs and devices to patients and how are those dispensers compensated?
a) Medicinal ProductsPrescription drugs may only be dispensed to patients after a prescription by a physician, and can only be dispensed by pharmacies (where also online order is possible), but not by LUA distributors (i.e. medicines sold outside of pharmacies).
The contingency storage of wholesalers shall correspond to two months of ordinary sales and will be in addition to the warehouse the wholesaler would otherwise have had. The wholesaler’s cost of storage is offset by raising the maximum purchase price for pharmacies by 1% for the drugs in question from the same date. The requirement is included in the Regulation on wholesale business with medicines (FOR-1993-12-21-1219), cf. Section 5.
b) Medical Devices Distribution by Professionals When importing medical equipment for professional use, there is therefore a requirement that the equipment is CE marked, has Norwegian labeling and Norwegian instructions for use, and be registered in the Norwegian equipment register. In addition For more detailed information on importing goods in general, see the Customs website.In addition to Norwegian producers, any Norwegian responsible representative, i.e. every natural or legal person established in the EEA area and explicitly designated by the manufacturer located outside the EEA area, acting on behalf of the manufacturer and which can be contacted by authorities and agencies within the EEA in respect of the manufacturer’s obligations under the regulations on medical devices may be responsible for registration.
Any natural or legal person assembling equipment bearing the CE mark has a duty to register in the equipment register as described in the Regulations on Medical Devices Section 2-8 and the Act on Medical Devices Section 10.
For personal use
The Medical Devices Act applies in principle to all use of medical devices, whilst the Medical Devices Regulations apply to anyone who manufactures, markets or markets equipment for use in Norway. When purchasing medical equipment that does not comply with the regulations, the person who has purchased / imported the equipment may risk that Customs stops the shipment and that the content is either destroyed or sent back to the sender.
Free samples
There are no specific Norwegian regulations regarding the delivery of free samples for medical devices. The basic requirements for free samples are similar to those for other medical devices. Medical devices that meet the requirements of the regulations must be affixed to the CE marking and can then be freely marketed within the EEA / EU. Labelling and instructions for free samples must be in Norwegian, similar to other equipment.
15. What are the professional and legal responsibilities of those who dispense drugs and devices? What role do they play in providing patient care, information, and safety?
All Health Care Personnel (“HCP”)’s, including physicians and pharmacists has a general duty to provide their services, such as the dispensing of drugs and medical devices, in accordance with the requirements for professional prudence and caring assistance that can be expected based on their qualifications, the nature of their work, and the situation at large, cf. the Healthcare Personnel Act (LOV-1999-07-02-64) section 4.
When HCP’s dispense drugs and devices they are obligated to give the patient sufficient information about the drug or device so that the patient can use the drug or device correctly, cf. the Pharmacy Act (LOV 2000-06-02-39) section 6-5 with reference to distribution from pharmacies.
Also in pharmacies there is an “information duty” with respect to information provided on distributed medicine, cf. Regulation on pharmacies section 40 and section 42 if sold online.
For distributors outside of pharmacies they must not give any “medical advice” orally and must if asked always refer the question to a physician or pharmacy, cf. (“LUA”) (Nw. Legemiddel utenfor apotek) regulation (FOR-2003-08-14-105) Section 12.
If there are several drugs available that are considered equivalent (e.g. generics or biosimilars), pharmacists and physicians must inform the patient about the alternatives and the price.