Traditional Medicines and OTC Products
All you need to know about traditional medicines and OTC products in Latvian pharma. Prepared in association with TGS Baltic, a leading law firm in Latvia, 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?
Traditional herbal medicinal products are regulated by the PL and its regulations.
Traditional herbal medicinal products may receive a marketing authorization following a simplified registration procedure.
For traditional herbal medicinal products to be qualified for a simplified registration procedure, they should fulfil specific criteria established by laws, e.g., they must have indications exclusively appropriate to traditional herbal medicinal products, which, by virtue of their composition and purpose, are intended and designed for use without the supervision of a medical practitioner; the period of traditional use has already elapsed (herbal medicines have been used for at least 30 years, including at least 15 years within the EU); the data on the traditional use of the medicinal product are sufficient, etc.
The presence in the herbal medicinal product of vitamins or minerals, for the safety of which there is well-documented evidence, should not prevent the product from being eligible for simplified registration, provided that the action of the vitamins or minerals is ancillary to that of the herbal active ingredients regarding the specified claimed indication(s).
2. Can these traditional, herbal, complementary, or alternative products be advertised directly to the public?
Yes, traditional herbal medicinal products may be advertised directly to the public.
3. What health, advertising, and marketing claims may be made for traditional, herbal, complementary, or alternative products?
Advertisement of traditional medicinal products must contain mandatory information, established by laws, e.g., the name of a medicinal product, the pharmaceutical form and strength of the medicinal product, a list of information which is essential for the proper use of the medicinal product (therapeutic indications, the method of administration, dosage, special warnings, contra-indications), etc.
In addition, advertising to the general public should not include any restricted information, e.g., the information:
- that suggests treatment by mail or provides advice in another similar way and which gives the impression that the diagnosis may be determined without involving a HCP;
- suggests that the effects of the medicinal product are guaranteed, use of the medicinal product is unaccompanied by adverse reactions and the effects of the medicinal product are equivalent to, or are better than, those of another method of medical treatment or another medicinal product;
- suggests that the overall health condition of the patient will improve significantly by taking the medicine product;
- suggests that the health of the patient may deteriorate by not taking the relevant medicinal product;
- which is directed exclusively or principally at children;
- refers to recommendations by scientists, health care professionals, or such persons who are not part of any of the abovementioned categories, but could encourage the consumption of medicinal products because of their celebrity.
4. What are the regulatory requirements for over-the-counter (non-prescription) medications?
Over-the-counter (non-prescription) (OTC) medications are regulated by the PL and its regulations.
OTC products are registered in accordance with the general procedure applied to the registration of all medical products. The application and other documents for the registration of OTC products must be submitted to the SAM.
OTC products may be defined as medicinal products which meet certain criteria established by laws, e.g.:
- they are not likely to present a danger either directly or indirectly, even when used correctly, if utilized without medical supervision;
- they do not contain substances or preparations thereof, the activity and/or adverse reactions of which require further investigation;
- they are not specifically intended for hospital treatment;
- its use may not produce very serious adverse reactions requiring a prescription drawn up as required by a specialist and special supervision throughout the treatment;
- they do not contain a substance classified as a narcotic or a psychotropic substance;
- they do not contain such novel substances, which, due to insufficient use or lack of experience, may be comparable to narcotic or psychotropic substance;
- medicinal products are not likely, if incorrectly used, to present a substantial risk of medicinal abuse, to lead to addiction or be misused for illegal purposes, etc;
- they do not have serious side effects which need to be administered by a medicine practitioner throughout the treatment;
5. Are there any limitations on locations or channels through which OTC products may be sold?
Currently OTC products may be sold in pharmacies, by mail and also on the internet.
6. What health, advertising, and marketing claims may be made for OTC products?
Advertisement of OTC medicinal products must contain mandatory information established by laws, e.g., the pharmaceutical form and strength of the medicinal product; a list of information, which is essential for the proper use of the medicinal product (therapeutic indications, the method of administration, dosage, special warnings, contra-indications), etc. Advertising of OTC products to the general public may not include any information that is mentioned in answer No. 3 above.
7. Can OTC products be marketed or advertised directly to the public?
Yes, OTC products may be advertised directly to the public.
8. What is the mechanism by which a prescription-only product can be converted to an OTC product?
A prescription-only product can be converted to an OTC product by re-registering the medicinal product or by changing the classification thereof according to certain criteria set out in the Rules of the Cabinet of Ministers “On classification of Medicines”, PL and the European Commission’s recommendation for the modification of the classification of medicinal products for human use.
9. What are the requirements for the importation of either traditional medicines or OTC products?
In order to import either traditional medicines or OTC products from third countries (non-EEA countries), it is necessary to obtain a manufacturing licence.
Medicinal products importable from third countries must be manufactured:
- by the companies duly authorized by the competent authorities of that country to engage in the manufacturing of medicinal products, and
- in accordance with the standards of good manufacturing practice (GMP), which are at least equivalent to those laid down by the European Union.
Every batch of medicines imported from third countries must be certified as having been manufactured and tested in accordance with the GMP and in conformance with the marketing authorisation, before it can be released onto the market in Latvia (and the EU). If the medicinal product is manufactured outside the EU and has been imported, it needs to undergo full analytical testing in the EU, unless a mutual recognition agreement is in place between the EU and the exporting country.