Traditional Medicines and OTC Products
The low-down on the situation regarding traditional medicines and OTC products in Slovakia. Prepared in association with PRK Partners, a leading global law firm, this is an extract from The Pharma Legal Handbook: Slovakia, available to purchase here for USD 99.
1. What are the regulatory requirements for traditional, herbal, complementary, or alternative medicines and devices?
Traditional herbal medicinal products and homeopathic medicinal products are regulated by the Act on Medicinal Products and its regulations. Traditional herbal medicinal products may receive a marketing authorization following a simplified registration procedure (e.g., it is not required to submit the documentation about results of the clinical trial). The applicant has to submit evidence published in scientific works that the herbal medicinal product has been used for at least 30 years before the submission of the application, including at least 15 years within the EEA member states. This is, however, not required if the traditional herbal medicinal product subject to the application contains herbal preparations or herbal substances listed in the EU list of herbal preparations and herbal substances issued by the European Commission. In case of a traditional herbal medicinal product non listed in the EU list, the State Institute of Drug Control takes into account the marketing approval issued by the competent authority of another EEA member state when assessing the application. If the herbal medicinal product has been used in the EEA member states less than 15 years, but still fulfills the remaining requirements for the simplified registration procedure, the State Institute for Drug Control passes the application to the Committee for Herbal Medicinal Products (HMPC) which has been set up at the European Medicines Agency in order to assess whether the requirements for the simplified registration procedure have been fulfilled.
Homeopathic medicinal products may also receive a marketing authorization following a simplified registration procedure if specific requirements under the Act on Medicinal Products are met, e.g. they are administered orally or externally, they may not contain more than 1 part per 10,000 of the mother tincture or more than 1:100th of the smallest dose used in allopathy with regard to active substances whose presence in an allopathic medicinal product results in the obligation to submit a doctor’s prescription. Otherwise, the process of the marketing authorization is the same as in case of (usual) medicinal products.
2. Can these traditional, herbal, complementary, or alternative products be advertised directly to the public?
Yes, subject to certain restrictions (please refer to Answer No. 17 of Chapter 3: Marketing, Manufacturing, Packaging & Labeling, Advertising).
In addition, with respect to traditional herbal medicinal products, in case of any advertising of medicinal products intended for the public the marketed medicinal product must contain also the following text: “Traditional herbal medicinal products for use in indications verified exclusively based upon long-standing use.”
In addition, the Act on Advertising enables the advertising of homeopathic medicinal products which are not registered in the Slovak Republic.
3. What health, advertising, and marketing claims may be made for traditional, herbal, complementary, or alternative products?
All medicinal products, including traditional herbal and homeopathic medicines are subject to advertising restrictions regulated by the Act on Advertising. For further information please refer to Answer No. 17 of Chapter 3: Marketing, Manufacturing, Packaging & Labeling, Advertising.
The advertising of medicinal products, regardless of the targeted group (professional or non-expert public), must be consistent with the summary of product characteristics, must promote the rational use of the medicinal product by providing the objective information on the product characteristics, without exaggerating the characteristics of the medicinal product, and at the same time, the advertising shall not be misleading. In addition to the general advertising requirements, any advertising of medicinal products intended for the public shall be drawn so that it is clear that it is an advertising and that the marketed medicinal product can be clearly identified and contain the particulars specified in the Act on Advertising (e.g., the name of the medicinal product, an explicit and understandable appeal to the users to carefully read the user’s written information that is accompanied to the medicinal product). The advertising of medicinal products intended for the public shall not contain several elements specified in the Act on Advertising which, e.g. gives the impression that medical examination or medical treatment is unnecessary, gives the impression that the effects of the medicinal product are guaranteed and are not accompanied by any adverse effects or are better than or equal to the effects of another medicinal product or other treatment, suggests that good health could be improved by using the medicinal product.
The Act on Advertising provides also specific restrictions for advertising of traditional herbal medicinal products, namely the text must contain the following: “Traditional herbal medicinal product for indications certified exclusively for long-term use.”
4. What are the regulatory requirements for over-the-counter (non-prescription) medications?
Over-the-counter medicinal products are regulated by the Act on Medicinal Products and its regulations. Process of registration, marketing authorization, manufacturing etc. is in general the same as for all medicinal products. For more information please refer to Answers in Chapter 3: Marketing, Manufacturing, Packaging & Labeling, Advertising.
5. Are there any limitations on locations or channels through which OTC products may be sold?
Over-the-counter medicinal products may be sold only in pharmacies. The online sale of over-the-counter medicinal products can only be performed by the holder of the license to operate a public pharmacy.
6. What health, advertising, and marketing claims may be made for OTC products?
Advertising and marketing of over-the-counter medicines are regulated by the same regulations as other medicinal products. For further information please see Chapter 3: Marketing, Manufacturing, Packaging & Labeling, Advertising.
7. Can OTC products be marketed or advertised directly to the public?
Over-the-counter medicines may be marketed (but only via pharmacies – please refer to Answer No. 5 of Chapter 4: Traditional Medicines and Over-the-Counter Products) and advertised directly to the public. For further information please refer to Answer No. 17 of Chapter 3: Marketing, Manufacturing, Packaging & Labeling, Advertising.
8. What is the mechanism by which a prescription-only product can be converted to an OTC product?
The State Institute for Drug Control re-evaluates the classification of a medicinal product in the process of prolonging the registration of the medicinal product or in case when new findings on a registered medicinal product are discovered. If the State Institute for Drug Control discovers new facts about the quality, effectiveness and safety of a medicinal product, it will assess the classification and, if necessary, modify the classification in accordance with the criteria set out in Act on Medicinal Products.
If the State Institute for Drug Control changed the classification of a medicinal product on the basis of pharmacological-toxicological testing or clinical trials, the application of another applicant for a change of the classification of a medicinal product containing the same active substance will not rely on the results of these tests one year after the first change in the classification of the medicinal product.
9. What are the requirements for the importation of either traditional medicines or OTC products?
Generally, in order to import medicinal products (including the traditional herbal and over-the-counter medicinal product) from the third countries (non-EEA countries), it is necessary to obtain a manufacturing authorization. The imported medicinal products must comply with the GMP requirements. Every batch of imported medicinal products manufactured in third countries must undergo an analysis of all active substances in an EEA member state in line with the registration requirements before it can be released into the EEA market (including the Slovak market). Certain third countries have in place a mutual recognition agreement between the EU and the third country. In such case, special conditions are applicable for such import, e.g. the full analytical testing is not required. If the medicinal product has been released to an EEA member state, it is possible to import it into the Slovak Republic “only” within the authorization for wholesale distribution of the medicinal products.