Traditional Medicines and OTC Products
Key legal info on traditional medicines and OTC products 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 are the regulatory requirements for traditional, herbal, complementary, or alternative medicines and devices?
The Medicines Act (LOV-1992-12-04-132) provides for any procedure for the MA of traditional medicines, including herbal and homeopathic medicines, whilst the Medical Devices Act (LOV-1995-01-12-6) sets out details relation to equipment/devices.
a) Traditional Medicine
- Import of pharmaceuticals from the EEA area (as well as procurement, storage, distribution, export 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 the 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.
- The NoMA must regardless be notified when such activities are planned. o 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 5 May 2020).
- There are special obligations for the distribution of pharmaceutical’s 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 distribution of medicinal products, section 6(FOR-1998-04-27-455).
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 in modules 3-5. 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 13-13 and 13-14.
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. Medical devices Act (LOV-1995-01-12-6).
- 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 is 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 and vitamin and mineral products are often associated with the concept of health food and must be notify 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 factual”. 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-1983-0301-628) 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 may cause NoMA to make a decision on advertising bans or that the they imposes a fee.
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 13-5 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 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 regulations 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 define offers 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 or 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 that deal 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 cited as 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 referred to 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 ».
The Medicines Regulation Section 13-14 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 labeling and, if appropriate, package insert 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 whether 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 lot number;
- registration number;
- “homeopathic medicine – without approved 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 13-13 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 Use Area 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 register with the Food surveillance authority and only listed drugs according to the medicines sold outside the pharmacies (LUA-Regulation, FOR-2003-08-14-1053). In addition there are rules on placing of the OTC and on marketing in the stores etc, that are not pharmacies. There is a list is found here updated 23 March 2020 of drugs which may be sold OTC elsewhere than pharmacies.
The Medicines Act limits access to for 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. 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 regulations 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.
The 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 the 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 the NoMA, on each page of the website, which identifies where the seller of the medicines is established,
- a link to the 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 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 follow from the Medicines Regulation (section 13-5) that 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.
Such 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.
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 in question 2. 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. 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, the 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 the 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 / 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)
- 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 3-2 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 is allowed to import 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 generally 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:
- alpha lipoic acid
- omega-3 fatty acids
- 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:
- Huperizine A