Legal & Regulatory > Belgium > Traditional Medicines and OTC Products

A brief overview of the situation regarding traditional medicines and OTC products in Belgium. Prepared in association with ALTIUS, a leading law firm in Belgium, this is an extract from The Pharma Legal Handbook: Belgium, available to purchase here for USD 99.

1. What are the regulatory requirements for traditional, herbal, complementary, or alternative medicines and devices?

The Law of 25 March 1964 on the medicines distinguishes between homeopathic medicines, traditional herbal medicines and herbal medicines.

All three categories are subject to a registration procedure before the FAMHP. Homeopathic medicines and traditional herbal medicines can be subjected to a simplified registration procedure provided they meet certain criteria.

2. Can these traditional, herbal, complementary, or alternative products be advertised directly to the public?

The Royal Decree of 7 April 1995 on information and advertising of medicines for human use explicitly includes homeopathic medicines and traditional herbal medicines in its scope.

Please refer to  Marketing, Manufacturing, Packaging & Labeling, Advertising, Question 17 regarding the obligations for advertising contained therein. The provisions of the Royal Decree involving advertising to the public indeed do not differ much for homeopathic medicines and traditional herbal medicines. Just like advertising for regular medicines should comply with the SmPC, all aspects of the advertising for homeopathic medicines must comply with the data included in the patient information leaflet or the labelling (incl. for information disseminated through a so-called information campaign involving such a product).

One difference is that, for a traditional herbal medicine, advertising to the public must state “traditional herbal medicine for use in one or more specified indications, exclusively based on long-term use”.

3. What health, advertising, and marketing claims may be made for traditional, herbal, complementary, or alternative products?

Please refer to Marketing, Manufacturing, Packaging & Labeling, Advertising, Question 17.

4. What are the regulatory requirements for over-the-counter (non-prescription) medications?

Over-the-counter medicines are subject to the same requirements as prescription medicines and are therefore governed by the Law of 25 March 1964 on the medicines.

5. Are there any limitations on locations or channels through which OTC products may be sold?

OTC products may be sold in pharmacies and over the Internet by pharmacies open to the public (see Marketing, Manufacturing, Packaging & Labeling, Advertising, Question 18).

6. What health, advertising, and marketing claims may be made for OTC products?

Please refer to Marketing, Manufacturing, Packaging & Labeling, Advertising, Question 17.

7. Can OTC products be marketed or advertised directly to the public?

Marketing or advertising to the public is permitted for OTC products though the prohibition of advertising any unauthorized, banned or suspended medicine still applies (please refer to Marketing, Manufacturing, Packaging & Labeling, Advertising, Question 17).

8. What is the mechanism by which a prescription-only product can be converted to an OTC product?

The Minister of Public Health or his representative can alter the nature of a medicine (such as OTC or prescription-only) either on its own initiative, or following an application of the holder of the marketing authorisation.

9. What are the requirements for the importation of either traditional medicines or OTC products?

Please refer to Marketing, Manufacturing, Packaging & Labeling, Advertising, Question 7.