Marketing, Manufacturing, Packaging & Labeling, Advertising
All about marketing, manufacturing, packaging & labeling, advertising in Norwegian Pharma. Prepared in association with DLA Piper, a leading law firm in Norway, this is an extract from The Pharma Legal Handbook: Norway, available to purchase here for USD 99.
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 If the application subsequently is withdrawn, this fee will not be reimbursed.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 analyzes 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 analyzes himself. Alternatively, the importer may purchase the analyzes 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/labeling of medicine and devices must be available in Norwegian also for parallel imported drugs, and the labeling 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?
The Medicines Regulation chapter 13 regulates advertisement for pharmaceuticals. Section 13-7 states that advertisement of pharmaceuticals to HCPs may not be related to distribution of goods, gifts, services or other types of services of monetary value, except where the goods or services has insignificant value.
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.
Regarding 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 gifts.
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 Products
Pursuant 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
b) Medical Devices
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?
NoMA 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 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.
b) Medical Devices
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 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?
See 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.
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.
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 Devices
According 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 , conf. Section 2-7.
14. What information must be included in medicine and device labeling?
a) Medicinal Products
The national labeling 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,
- 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.
Space must be placed on the packaging to indicate dosage.
In addition to what follows from the first paragraph, the Norwegian Medicines Agency may require that the drug be labeled 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 accord- ing to Section 3-26:
- the name of the medicinal product, as provided in § 3-29 (a);
- 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 easily readable, clearly understandable and should not be possible to deleted.
Drug packages must be designed in such a way as to reduce the risk of con- fusion and misuse. The final packaging design is approved by the NoMA. The NoMA may require that drug packages be equipped with graphic elements, including the use of colors.
b) Medical Devices
The 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 Regulation on Medical Equipment section 2-4 to 2-6.
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.
Follows from the regulation on medicines from pharmacies (FOR-1998- 04-27-455) Section 12 that When dispensing a drug, it must be ensured that it is adequately labeled 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.
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 1 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 labeled in accordance with regulations on flammable and explosive products 2.
- 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 on labeling requirements both in the Medicine Regulation 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 packs 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 an health personnel.
According to the Medicines Regulation Sections 13- 5 and 13-6 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.
Advertising must not contain recommendations from a physician, dentist, veterinarian, marine/ fish health biologist or others who, by virtue of their reputation, may encourage the use of medicines.
Illustrations must only convey information about the drug’s properties and use in an objective manner without exaggerating its effect. Illustrations must not be misleading or play to strong effects, e.g. body that is altered by illness or injury.
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 prescription vaccines for people who are part of 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 tumor diseases, chronic insomnia, diabetes or other metabolic disorders.
Advertising for other medicinal products in medicine packs is not permitted in addition to the approved package leaflet. It is not allowed to associate advertising with objects, gifts, prizes or any other kind of reward. Distribution of free drug samples to the public is not allowed.
Advertising to the public must always be made so that it is clearly stated that the advertisement is 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) if the medicinal product contains only one active substance;
- 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, treatment or consultation with a veterinarian or fish health biologist is superfluous;
- propose or indicate how patients or pet owners can diagnose themselves;
- 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 be impaired if you do not take the medicine;
- be directed exclusively or mainly at children;
- refer to the advice of health professionals or scientists in support 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.
Advertisement for prescription drugs can only be targeted at HCP’s. In addition to the abovementioned general rules regarding advertisement, the Medicines Regulation provides that advertisement of medicines to HCP’s shall not be linked with gifts, for more detailed see above [Question 8].
There are also strict rules for advertisement to health personnel (HCP) and free samples.
Regarding advertisement of medical devices, the Medical Devices Act section 5 states that marketing of medical devices, shall be in compliance with the Act. This entails regulations regarding the labelling, description of the purpose etc. must be followed when marketing the products. In addition the Marketing Control Act (LOV-2009-01-09-2) prohibits misleading advertisement.
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, confer 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 the 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 17 also applies for advertising 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, confer 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.