Traditional Medicines and OTC Products
All about traditional medicines and OTC products in Luxembourg. Prepared in association with Wildgen, a leading global law firm, this is an extract from The Pharma Legal Handbook: Luxembourg, available to purchase here for USD 99.
1. What are the regulatory requirements for traditional, herbal, complementary, or alternative medicines and devices?
According to article 52-2 of Grand-Ducal regulation of 15 December 1992 relating to the marketing of medicinal products as amended, traditional herbal medicinal products which meet the following requirements are registered through a simplified registration procedure, i.e. the application to be filed have less documents to annex than in case of the standard application related to medicinal products.:
- they have indications exclusively appropriate for traditional herbal medicinal products which, by their composition and their intended purpose, are designed for and intended for use without the monitoring of a doctor for diagnosis, prescription or follow-up of treatment;
- they are intended exclusively for use in a specified dosage and posology;
- they are preparations for oral, external and/or by inhalation use;
- the period of traditional use has expired;
- data on the traditional use of the medicinal product are sufficient; in particular, the safety of the product is demonstrated under the specified conditions of use and the pharmacological effects or efficacy of the medicinal product are plausible due to the longstanding use and experience.
However, when the Ministry of Health considers that a traditional herbal medicinal product meets the criteria for a prior marketing authorization, the simplified registration procedure shall not apply.
2. Can these traditional, herbal, complementary, or alternative products be advertised directly to the public?
According to article 52-8 of the Grand-Ducal regulation of 15 December 1992 relating to the marketing of medicinal products as amended, advertising for traditional herbal medicinal products shall contain, in addition to the standard provisions governing the advertising of medicinal products, the specific mention “traditional herbal medicinal product to be used for one/several specified purpose(s) on the exclusive basis of the longstanding use”.
3. What health, advertising, and marketing claims may be made for traditional, herbal, complementary, or alternative products?
There is no specific regulation for traditional herbal products related to this subject, so the general regulatory framework for the advertising related to the medicinal products applies here.
4. What are the regulatory requirements for over-the-counter (non-prescription) medications?
There is no specific regulatory requirements for over-the-counter (non-prescription) medications, so the general regulatory framework for all medicinal products would apply.
Consequently, a marketing authorization is required before the launching of the OTC on the market.
5. Are there any limitations on locations or channels through which OTC products may be sold?
According to article 3bis of the law of 25 November 1975 concerning the deliverance of medicinal products to the public as amended, OTC products are authorized to be sold on the internet in addition to the classical channels (please refer to question 18 in Chapter 3).
6. What health, advertising, and marketing claims may be made for OTC products?
The general regulatory framework related to medicinal products applies.
7. Can OTC products be marketed or advertised directly to the public?
Yes, pursuant to the general regulatory framework foreseen in article 19 of the Grand-Ducal regulation of 15 December 1992 relating to the marketing of medicinal products as amended, medicinal products except the following categories can be advertised directly to consumers:
- which can only be delivered on a medical prescription,
- which contain psychotropic substances or narcotics,
- which are reimbursable by social insurance.
As OTC products can be delivered without medical prescription, they can be marketed or advertised directly to the public if they fulfill the other requirements above.
8. What is the mechanism by which a prescription-only product can be converted to an OTC product?
Pursuant to article 30 of the Grand-Ducal regulation of 15 December 1992 relating to the marketing of medicinal products as amended, the Ministry of Health, when allowing the marketing authorization of the medicinal product, specifies if the medicinal product is part of the category of medicinal product subject to prescription or is part of the category of medicinal product not subject to prescription.
As a general principle, medicinal products subject to prescription are those likely presenting a danger either directly or indirectly, even when correctly used, if used without medical monitoring.
At the moment of the renewal of the marketing authorization, or in case of new circumstances, the Ministry of Health can reexamine the category under which the medicinal product is classified and can change its classification.
9. What are the requirements for the importation of either traditional medicines or OTC products?
There is no specific requirements for the importation of either traditional medicinal products or OTC products. General framework should apply.