Traditional Medicines and OTC Products
The ins and outs of traditional medicines and OTC products in Czech Republic. Prepared in association with PRK Partners, a leading law firm in Czech Republic, this is an extract from The Pharma Legal Handbook: Czech Republic, 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 subject to specific regulation set out in the Act on Drugs.
Traditional herbal medicinal products for human use will be granted marketing authorization following a simplified authorization procedure provided that they meet the following conditions:
- they are intended for oral, external or inhalation use;
- they are intended to be administered only at a certain strength and dosage;
- their indications correspond solely to the indications of traditionally used
herbal medicinal products, and have been determined and devised on the basis of their composition and purpose for use without the need for supervision by a doctor for diagnostic purposes, prescription or treatment monitoring;
- the period of traditional use (i.e. 30 years, out of which at least 15 years in the EEA) has expired;
- there is sufficient data on the traditional use of the medicine in question; in particular, it has been shown that the product is not harmful under the specific conditions of use and that the pharmacological effects or efficacy of the product are evident on the basis of long-term use and experience.
The simplified process for obtaining a marketing authorization generally follows the standard procedure with the difference that some of the standard application requirements do not apply, such as the evaluation of the potential risk of the product on the environment or the results of clinical testing. If a specific herbal medicinal product has been used in the EEA member states for less than 15 years, but still fulfills the remaining requirements for the simplified authorization procedure, the State Institute for Drug Control submits the application to the Committee on 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 met.
Homeopathic medicinal products are subject to a simplified marketing authorization under which no evidence of therapeutic efficacy is required provided that they meet the following conditions:
- they are administered orally or externally;
- no therapeutic indication is stated on their label or in any information concerning the product; and
- dilution can guarantee the safety of the product.
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 Marketing, Manufacturing, Packaging & Labeling, Advertising). In addition, any advertisement as well as the labeling and package leaflet of a traditional herbal medicinal product must contain the following text: “The use of this traditional herbal medicinal product is based solely on experience gained through long-term use”.
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 general advertising restrictions as set out by the Act on Advertising. For further information please refer to Answer No. 17 of Marketing, Manufacturing, Packaging & Labeling, Advertising.
The Act on Drugs also establishes a specific requirement for the advertising of traditional herbal medicinal products, i.e. that the packaging or leaflet must contain the following text: “The use of this traditional herbal medicinal product is based solely on experience gained through 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 Drugs and its implementing regulations. The process of obtaining marketing authorization, manufacturing, distribution, etc. is in general the same as for all other medicinal products. For more information please refer to the Answers in Marketing, Manufacturing, Packaging & Labeling, Advertising.
Whether a medicine may be distributed without a prescription is determined by the State Institute for Drug Control in accordance with applicable provisions of the Act on Drugs. This act specifies under what conditions the State Institute for Drug Control may allow the distribution of a medicinal substance without a doctor’s prescription. A medicine may not be distributed without a prescription if (i) it may, even if used correctly, constitute a direct or indirect hazard when used without medical supervision, (ii) it is often and widely used improperly and as a consequence may represent a direct or indirect danger to human health, (iii) contains substances or preparations of substances whose efficacy or adverse effects require further monitoring, or (iv) it is intended for parenteral administration.
5. Are there any limitations on locations or channels through which OTC products may be sold?
The majority of OTC products may only be sold in pharmacies or through their online shops. The online sale of certain OTC products may be prohibited by a decision of the State Institute for Drug Control; this may be done with respect to OTC products which can be dangerous to human health and the danger can be prevented (i) by an expert consultation with a pharmacist prior to the use of the product or (ii) by imposing certain restrictions on the dispensing of the product.
Selected medicinal products that can be used without consulting a doctor or pharmacist, such as teas, disinfectants or painkillers, can also be sold in other outlets, such as stores at gas stations or food markets. There is no need to obtain any specific license to sell these products (a regular retail trade license suffices); however, the business owner has to inform the State Institute for Drug Control about the commencement and termination of such operations (sale) and has to ensure that each individual selling any such products obtains a certificate of professional competence. The business owner can only purchase the medicinal products from distributors and manufactures holding the relevant license from the State Institute for Drug Control. The business owner also has to ensure that the medicinal products are stored separately from other products.
6. What health, advertising, and marketing claims may be made for OTC products?
Advertising and marketing of OTC products are regulated by the same regulations as other medicinal products. For further information please see Marketing, Manufacturing, Packaging & Labeling, Advertising, in particular Answer No. 17.
7. Can OTC products be marketed or advertised directly to the public?
Yes, OTC products can be advertised directly to the public. For further information please see Marketing, Manufacturing, Packaging & Labeling, Advertising, in particular Answer No. 17.
The majority of OTC products can be sold directly to the public through pharmacies or their online shops. Online sale of certain OTC products may be prohibited by a decision of the State Institute for Drug Control. Certain medicinal products that can be used without consulting a doctor or pharmacist, such as teas, disinfectants or painkillers, can also be sold in other outlets, such as stores at gas stations or food markets.
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 dispensing classification of a medicinal product when extending the marketing authorization of a product or if new findings concerning the product are discovered. In the context of the re-evaluation, the State Institute for Drug Control aims to ensure that medicinal products with the same strength, packaging size and active sub- stance are classified in the same dispensing category.
If it is concluded that the dispensing category needs to be changed during the renewal of the marketing authorization process, the State Institute for Drug Control will change the dispensing category within its decision on the extension of the marketing authorization. In other cases, the State Institute for Drug Control will initiate a procedure to amend the marketing authorization. The marketing authorization holder is then required to submit proposals for amendments to the Summary of Product Characteristics, package leaflet and labeling on the packaging of the product to the State Institute for Drug Control.
9. What are the requirements for the importation of either traditional medicines or OTC products?
Generally, in order to import medicinal products (including traditional herbal and over-the-counter medicinal products) from non-EEA countries, it is necessary to obtain a manufacturing authorization from the State Institute for Drug Control. The imported medicinal products must comply with the GMP requirements. Every batch of imported medicinal products manufactured in a third country must undergo an analysis of all the active substances contained therein in an EEA member state in accordance with the registration requirements before it can be released onto the EEA market (including the Czech market). Certain third countries have a mutual recognition agreement in place between the EU and such third country. In such case, special conditions are applicable for such importation, e.g. full analytical testing may not be required. If a medicinal product has been released in another EEA member state, it is possible to import it into the Czech Republic under the authorization for wholesale distribution of medicinal products.
Importation from the countries of the European Union is permitted within the concept of the parallel trade of medicines in accordance with the principle of free movement of goods within the EU. For further information please see Marketing, Manufacturing, Packaging & Labeling, Advertising, in particular Answer No. 7.