Traditional Medicines and OTC Products
Key legal info on traditional medicines and OTC products in Denmark. Prepared in association with Gorrissen Federspiel, a leading law firm in Denmark, this is an extract from The Pharma Legal Handbook: Denmark, available to purchase here for GBP 75.
1. What are the regulatory requirements for traditional, herbal, complementary, or alternative medicines and devices?
Natural medicinal products, traditional herbal medicinal products, homeopathic medicinal products, and strong vitamin and mineral products are all special categories of medicinal products and are as a starting point governed by the Danish Medicines Act.
Natural medicinal products
Pursuant the Executive Order on natural medicinal products and traditional herbal medicinal products (Executive Order no. 1233 of 12 December 2005 on natural medicinal products and traditional herbal medicinal products, as amended), natural medicinal products are defined as medicinal products:
i. The active substances of which are only naturally occurring substances in doses that are not significantly higher than those found in the environment,
ii. That are meant for a) oral consumption, b) application on skin, or c) local application on mucous membranes,
iii. That are non-prescription products,
iv. With indications that only cover the treatment of minor diseases.
The requirements that apply to manufacturers of regular medicinal products apply equally to manufacturers of natural medicinal products.
Natural medicinal products must be authorized by the DKMA before they can be marketed in Denmark.
It is permitted to sell natural medicinal products outside pharmacies. Such retail sales do not require an authorization from the DKMA.
Herbal medicinal products and traditional herbal medicinal products
Herbal medicinal products are medicinal products the active substances of which consist solely of one or more plant based substances, one or more plant preparations, or a combination of the two.
Traditional herbal medicinal products are defined as herbal medicinal products that:
v. Are meant for humans,
vi. Have indications exclusively appropriate to traditional herbal medicinal products that, by virtue of their composition and purpose, are intended and designed for use without the supervision of a medical practitioner for diagnostic purposes, prescription or monitoring of treatment,
vii. Are exclusively for administration in accordance with a specified strength and posology,
viii. Are oral, external and/or inhalation preparations, and
ix. Fulfil the requirements on the period of traditional use (i.e. that the product must have been in medical use for at least 30 years, including 15 years in the EU).
The data on traditional use of the product must be sufficient. In particular, the product must prove not to be harmful in the specified conditions of use, and the pharmacological effects or efficacy of the product must be plausible on the basis of longstanding use and experience.
Traditional herbal medicinal products must be approved before being placed on the market. However, a traditional herbal medicinal product can receive an approval for marketing by way of a simplified procedure (registration).
Vitamin and mineral products
Strong vitamins and minerals are a category of medicinal products where the active substances consist exclusively of vitamins and/or minerals, and where the content of vitamins and minerals is considerably higher than the normal daily requirement of adult humans.
Strong vitamin and mineral products may only be sold in Denmark if an authorization has been issued by the DKMA. In the process of authorization, the DKMA generally sets out the same requirements on manufacturing, quality and documentation of safety apply with regard to vitamin and mineral products as with natural medicinal products.
Vitamin and mineral products may be authorized by way of the rules on so-called bibliographical procedure, i.e. an abridged procedure where the applicant may rely on well-established medicinal use for at least ten years, supported by bibliographic literature.
Strong vitamin and mineral products can only be authorised to prevent and cure cases of deficiency.
Strong vitamin and mineral products are exempt the exclusivity of pharmacies, meaning that the products may be sold to end users outside pharmacies.
2. Can these traditional, herbal, complementary, or alternative products be advertised directly to the public?
The advertising rules on medicinal products apply to all types of medicinal products for human beings and animals, including natural medicinal products, herbal medicinal products, traditional herbal medicinal products, and strong vitamins and minerals.
As mentioned above, natural medicinal products, traditional herbal medicinal products, and vitamin and mineral products may be sold outside pharmacies, and they are not prescription-only medicinal products. Consequently, they may be advertised directly to the general public provided the relevant requirements are complied with. For further information on advertising of medicinal products, please see Question 17 of Marketing, Manufacturing, Packaging & Labeling, Advertising.
3. What health, advertising, and marketing claims may be made for traditional, herbal, complementary, or alternative products?
The advertising rules on medicinal products apply to all types of medicinal products for human beings and animals, including natural medicinal products, herbal medicinal products, traditional herbal medicinal products, and strong vitamins and minerals. Please see Question 17 of Marketing, Manufacturing, Packaging & Labeling, Advertising.
4. What are the regulatory requirements for over-the-counter (non-prescription) medications?
The regulatory requirements applicable to over-the-counter medicinal products are generally the same as prescription medicinal products. Please see Question 3 of Regulatory, Pricing and Reimbursement, on the regulatory requirements in connection with development, manufacture and marketing, as well as Question 17 and 18 of Marketing, Manufacturing, Packaging & Labeling, Advertising, on advertising and sale.
A list of non-pharmacy restricted over-the-counter medicinal products can be found on the website of the DKMA. The list is updated daily.
5. Are there any limitations on locations or channels through which OTC products may be sold?
Yes, as a starting point, over-the-counter medicinal products are only permitted to be sold by licensed pharmacies. However, the DKMA may decide that certain over-the-counter medicinal products are to be exempted from the pharmacies’ exclusivity. Such medicinal products may be sold to end users by retail sellers that have been authorized by the DKMA.
6. What health, advertising, and marketing claims may be made for OTC products?
Please see question 17 of Marketing, Manufacturing, Packaging & Labeling, Advertising.
7. Can OTC products be marketed or advertised directly to the public?
Yes. Please see Question 17 of Marketing, Manufacturing, Packaging & Labeling, Advertising.
8. What is the mechanism by which a prescription-only product can be converted to an OTC product?
The DKMA may determine if an over-the-counter medicinal product which is reserved for exclusive sale in pharmacies should be available for sale outside pharmacies.
9. What are the requirements for the importation of either traditional medicines or OTC products?
Import of natural medicinal products, strong vitamin and mineral products, and over-the-counter products requires an authorization from the DKMA.