Traditional Medicines and OTC Products
A brief overview of the situation regarding traditional medicines and OTC products in Ukraine. Prepared in association with Sayenko Kharenko, a leading law firm in Ukraine, this is an extract from The Pharma Legal Handbook: Ukraine, available to purchase here for GBP 99.
1. What are the regulatory requirements for traditional, herbal, complementary, or alternative medicines and devices?
Ukkrainian legislation distinguishes between traditional and herbal medicines; furthermore, homeopathic preparations are as well recognized as medicines in Ukraine. There is no definition of complementary or alternative medicines and devices in Ukrainian legislation. However, it defines traditional (folk) medicine, which means the therapeutic, prevention, diagnostic methods based on the experience of many human generations, fixed in folk traditions, which do not require state registration. Practicing traditional (folk) medicine requires a license issued upon attestation.
Ukrainian legislation provided for certain differences regarding registration and marketing of different types of medicines. However, the general requirements on mandatory registration, licensing of manufacturing, import and whole and retail sales, and the special regime of advertising remain the same irrespective of the category of medicinal product.
Traditional medicines include medicinal products simultaneously qualifying
for five criteria:
- Having therapeutic indications applied exclusively for traditional medicines which are designed for application without medical supervision for diagnostic and treatment purposes;
- Intended for use strictly according to the indicated strength and dosage;
- Intended for oral, external or inhalational application;
- The period of their traditional application (over 30 years abroad and over 15 years in EU and/or Ukraine) has expired;
- There is enough data on traditional use of the preparation (safety, pharmaceutical effects, efficiency, etc.).
State registration of traditional medicinal products is carried out in a simplified way. The list of certain traditional preparations and their manufacturing prescriptions is designated by order of the Ministry and includes the list of simple medicinal products (e.g. ethanol, aqua ammonia, etc.).
Medicinal products made exclusively from herbal substances or herbal preparations are considered as herbal medicinal products. Such medicinal products may be originally made from whole, granulated or sliced plants, parts of plants, seaweed, mushrooms, raw dried or fresh fungi. GMP standards are applied to the quality of herbal substances and herbal preparations in Ukraine. Herbal medicines are subject to state registration by the Ministry on a general basis (with certain additional requirements).
Homeopathic medicinal products (produced from homeopathic raw materials) are also subject to state registration and shall be manufactured according to State Pharmacopoeia. Ukrainian legislation provides for simplified registration requirements for homeopathic medicinal products without therapeutic effect.
Dietary supplements, medicinal food products, and weight control food products are considered not as medicinal products and are not subject to the respective requirements, but as food products under Ukrainian legislation. However, such products are allowed for sale in pharmacies.
Medical devices are not considered as medicinal products and are not subject to the respective regulations. Such devices shall comply with requirements defined in technical regulations.
2. Can these traditional, herbal, complementary, or alternative products be advertised directly to the public?
All medicinal products (including traditional and herbal) are subject to common general and sectoral advertising regulations, defined in the Law of Ukraine “On advertising”.
Advertising of prescription medicines is prohibited. Only non-prescription medicines allowed for use in Ukraine can be advertised directly to the public. The list of non-prescription medicines is established by the order of the Ministry. Furthermore, the Law “On advertising” prohibits advertising of certain non-prescription medicines listed in the special order of the Ministry. Such prohibitions, however, do not apply to advertising in special periodicals for healthcare institutions and doctors, as well as for advertising disseminated at medical seminars and conferences.
Ukrainian legislation prohibits advertising of traditional (folk) medical practices applied to mass audience.
Advertising of dietary supplements to the public is allowed. However, it is subject to certain restrictions. Advertising of such supplements can not refer to any therapeutic effect, pain relief effect, contain letters of thanks, etc.
3. What health, advertising, and marketing claims may be made for traditional, herbal, complementary, or alternative products?
Legislatory requirements and restrictions for claims which may or shall be made for marketing and advertising, are uniform for all medicinal products. Advertising of medicinal products must contain:
- objective information about the medicine which makes it clear that the information is an advertisement and that the advertised product is a medicine;
- the requirement to receive a doctor’s advice before using the medicine;
- a recommendation to read the instructions on the use of the medicine;
- a warning: “self-treatment may be dangerous to your health” which must take up at least 15% of the advertising area.
It is prohibited to produce any advertisement which implies that a medicinal product is a food, cosmetic or other consumer product, or that its safety or efficiency is due to its natural origin. At the same time, advertisement of goods or food products which do not belong to medicinal products shall not refer to any therapeutic effect of such products.
Advertising of traditional (folk) medical practice (as well as conventional) is allowed depending on the relevant certification.
4. What are the regulatory requirements for over-the-counter (non-prescription) medications?
The sale category of medicinal products (prescription or non-prescription) is established during the state registration based on criteria established by order of the Ministry. The sale category is fixed in the registration certificate. The criteria used to determine the sale category of medicinal products includes the risk to health, the potential effects, the content (e.g. narcotic drugs, precursors), the method of consumption, etc. The list of non-prescription medicinal products is additionally fixed by the Ministry in a separate order.
The legislatory requirements to registration, importation, distribution (wholesale) and retail sale are the same both for prescription and non-prescription medicinal products. However, non-prescription medicinal products may be sold to consumers without prescription and may be advertised, unless they are included in the list of medicinal products prohibited for advertising. Furthemore, non-prescription medicinal products may be placed in pharmacies at counters or shop windows with free access for consumers, whereas prescription medicines shall be stored in separate cabinets without access for consumers.
5. Are there any limitations on locations or channels through which OTC products may be sold?
There is no difference in the sale channels for prescription and non-prescription medicinal products. Non-prescription medicines, as well as prescription ones, shall only be sold for wholesale in pharmaceutical warehouses and for retail in pharmacies or pharmacy branches (some exclusions are envisaged for rural areas, where medicines may be sold by certain healthcare institutions).
Trade in medicines can be made exclusively through pharmaceutical establishments and shall not be made through any electronic commercial means, by post, or by establishments other than pharmaceutical stores.
6. What health, advertising, and marketing claims may be made for OTC products?
Ukrainian legislation does not establish any special health, advertising, and marketing claims for OTC products. Such requirements are uniform for all medicinal products, as specified in question 3 of this chapter.
7. Can OTC products be marketed or advertised directly to the public?
Only non-prescription medicines allowed for use in Ukraine and not included in the special list of medicines prohibited from advertising may be advertised directly to the general public in Ukraine subject to requirements and restrictions as described in question 3 of this chapter and question 17 Marketing, Manufacturing, Packaging and Labeling, Advertising Overview.
8. What is the mechanism by which a prescription-only product can be converted to an OTC product?
There is no established procedure for conversion of a prescription-only product to an OTC product.
Changes of the API, medicinal form, dosage, etc, which might potentially affect the status of the medicinal product, will require new registration. In case of such changes to the product, which change its status from prescription to non-prescription, its owner shall apply for changes to the registration materials. Expert examination of such changes is made according to the producedure for registration of any new medicinal product. The owner receives the new registration certificate or extra sheet to the existing certificate depending on the nature of the changes.
9. What are the requirements for the importation of either traditional medicines or OTC products?
Ukrainian legislation provides for uniform rules of importation of medicinal products in Ukraine, irrespectively of their status or category. Only registered medicinal products are allowed for importation for the purpose of sale.
In order to import medicinal products to Ukraine, the importer shall comply with the licensing requirements and obtain an import license. An annex to the import license shall contain the list of medicines allowed for importation and the conditions for implementation of activities.
1) The Guidelines for Good Manufacturing Practice of Medicinal Products were adopted according to the Decree of the Ministry No.95 as of 16.02.2009 “On the approval of documents on procuring medicinal products quality”
2) According to Art. 17 of the Law of Ukraine “On Medicinal Products”