Traditional Medicines and OTC Products
Traditional medicines and OTC products in Estonia – a comprehensive legal overview. Prepared in association with TGS Baltic, a leading law firm in Estonia, this is an extract from The Pharma Legal Handbook: Baltics, available to purchase here for USD 99.
1. What are the regulatory requirements for traditional, herbal, complementary, or alternative medicines and devices?
Primary legislation for herbal medicines and traditional herbal medicines is the Medicinal Products Act and its regulations.
Marketing of herbal medicines requires a marketing authorization, which can be obtained through a simplified registration procedure (compared to other medicines). To be qualified for a simplified registration procedure, the applicant must submit (specific requirements for herbal medicinal products):
- a list of literature or an expert opinion, which confirms that the herbal medicine has been medically used for at least 30 years, including at least 15 years within the EU;
- an overview based on literature together with an expert opinion that confirms the safety of the medicinal product.
2. Can these traditional, herbal, complementary, or alternative products be advertised directly to the public?
Herbal medicines and traditional herbal medicines may be advertised directly to the public.
3. What health, advertising, and marketing claims may be made for traditional, herbal, complementary, or alternative products?
Advertising of herbal medicinal products falls under the same regulation as advertising of other medicinal products. Advertising of all medicinal products must meet the general requirements provided for in the Advertising Act and Medicinal Products Act and must be in full compliance with the information specified in the summary of product characteristics of the medicinal product.
Advertising of a medicinal product must facilitate rational use of the medicinal product by presenting information in an objective and unexaggerated way and must not be misleading and must not exaggerate the properties of the medicinal product.
It is prohibited to use material in advertising of a medicinal product to the public which:
- refers to a recommendation by scientists, health professionals or persons who, because of their celebrity, could encourage the consumption of the advertised medicinal products;
- gives the impression that a medical consultation or surgical operation is unnecessary by offering a diagnosis or by other comparable means;
- suggests that the effects of taking the medicine are ensured, are unaccompanied by adverse reactions or are better than, or equivalent to those of another treatment or medicinal product;
- suggests that the health of the subject can be enhanced only by taking the medicine;
- suggests that the health of the subject could be affected by not taking the medicine;
- suggests that the medicinal product is a foodstuff, cosmetic or other consumer product;
4. What are the regulatory requirements for over-the-counter (non-prescription) medications?
Over-the-counter (OTC, non-prescription) medicines are regulated by the Medicinal Products Act and its regulations.
Requirements for development, manufacture, authorization and pricing of OTC medicines are in general the same as for all medicinal products.
5. Are there any limitations on locations or channels through which OTC products may be sold?
Currently OTC medicines may be sold only in pharmacies.
6. What health, advertising, and marketing claims may be made for OTC products?
Advertising of OTC medicines falls under the same regulation as advertising of other medicinal products. Please see above for details.
7. Can OTC products be marketed or advertised directly to the public?
OTC products can be marketed (by pharmacies only) and advertised directly to the public.
8. What is the mechanism by which a prescription-only product can be converted to an OTC product?
Upon issue of a marketing authorization, the State Agency of Medicines classifies the medicinal product as a medicinal product not subject to medical prescription (OTC product), a medicinal product subject to medical prescription or a medicinal product subject to restricted use.
Medicinal product subject to medical prescription can be converted to an OTC product by changing the classification according to certain criteria enacted by the Medicinal Products Act and its regulations. In order to convert a prescription medicine to an OTC product, application to the State Agency of Medicines shall be submitted.
9. What are the requirements for the importation of either traditional medicines or OTC products?
For the importation of medicinal products (including traditional medicines and OTC products) from third countries (non-EEA countries) an activity license for manufacture of medicinal products must be obtained. The activity license for manufacture is required because the importer has to take responsibility for the quality of the products manufactured in third countries and has to prove the quality of imported products.