Traditional Medicines and OTC Products
The ins and out of traditional medicines and OTC products in Lithuania. Prepared in association with TGS Baltic, a leading law firm in Lithuania, 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 Law of the Republic of Lithuania on Pharmacy 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 refers to a recommendation by scientists, health professionals or persons who, because of their celebrity, could encourage the consumption of medicinal products;
- that could, by a description, lead to erroneous self-diagnosis;
- which refers, in improper, alarming or misleading terms, to claims of recovery;
- which suggests that the effects of taking the medicine are guaranteed, are unaccompanied by side effects or are better than those of another treatment or medicinal product;
- suggests that the health of the subject can be enhanced by taking the medicine or affected by not taking the medicine, etc.;
- 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 (non-prescription) (OTC) medications are regulated by the Law of the Republic of Lithuania on Pharmacy 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 State Medicines Control Agency.
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;
- 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.
5. Are there any limitations on locations or channels through which OTC products may be sold?
Currently OTC products may be sold in pharmacies only.
However, there is a project of a new regulation, which, if comes into force, would allow the sale of OTC products also in other market places. For more information please see Regulatory Reforms.
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. 2 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 Law on Pharmacy 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 GMP and in conformance with the marketing authorisation before it can be released onto the market in Lithuanian (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.