Unavailability / Marketing status

Unavailability of medicinal and health products

Medicinal products may become unavailable for a number of reasons (unavailability of active substances, increase in demand, supply-chain issues, etc.).

The market authorisation holder for a medicinal product must fulfil certain obligations in the event of an interruption in the placing on the market of the medicinal product, or its withdrawal from the market. The Division of Pharmacy and Medicines (Division de la pharmacie et des médicaments - DPM) of the Health Directorate provides forms designed to simplify these procedures.

Regulatory framework – availability of medicinal products

Article 7 of the Law of 11 April 1983 (as amended), regulating the placing on the market and advertising of medicinal products, stipulates that:

'The market authorisation holder shall immediately submit to the Minister of Health and Social Security any new information constituting an addition to their registered marketing authorisation application file, and in particular any prohibitions or restrictions imposed by the competent authorities in their country of origin and in the countries where the medicinal product is marketed.'

(Law of 21 July 2012)

Any market authorisation holder that also holds an authorisation for the wholesale distribution of medicinal products shall be bound by the obligations incumbent upon them by virtue of the legislation governing the wholesale distribution of medicinal products.

Any market authorisation holder that does not hold an authorisation for the wholesale distribution of medicinal products shall provide persons with an authorisation for the wholesale distribution of medicinal products with an appropriate and continuous supply of the medicinal products which are covered by their market authorisation, and which have effectively been placed on the Luxembourg market, so that such wholesale distributors are able to cover the needs of the population.

More specifically, any market authorisation holder, regardless of whether or not they hold an authorisation for the wholesale distribution of medicinal products, shall provide wholesale distributors, at their request, with a continuous supply of the medicinal products which are covered by their market authorisation, and which have effectively been placed on the Luxembourg market, so that such wholesale distributors are able to fulfil the public-service obligation incumbent upon them by virtue of the legislation governing the wholesale distribution of medicinal products.'

Article 8-3, paragraph 2 of the Grand-Ducal Regulation of 15 December 1992 (as amended), on the placing on the market of medicinal products, stipulates that:

'The holder shall also give notice in the event of a temporary interruption in the placing of the medicinal product on the Luxembourg market, or a permanent withdrawal of the product from the Luxembourg market. Save in exceptional circumstances, such notice shall be given no later than two months before the interruption in the placing on the market of the medicinal product.' (G-D Reg. of 9 April 2013).