The Government in Luxembourg has announced the formation of ALMPS – Agence luxembourgeoise des médicaments et des produits de santé (Luxembourg Agency for Medicines and Health Products): a new National Medicines Agency.
The new agency will be under the authority of the Minister of Health, and will bring together official competencies in fields such as drugs and medical devices. Its role is to manage the potential risks these fields generate. The move brings Luxembourg into line with other EU countries, as it is currently one of very few to not have an equivalent agency.
The Minister of Health, Étienne Schneider noted:
“The creation of a National Medicines Agency is all the more necessary as the challenges we face are major, particularly as regards monitoring the quality and safety of medicines on the market, in order to prevent harmful, substandard or counterfeit medicines from reaching the public.”
Various countries have reported full and partial shortages of certain medicines at an increasing rate over recent years. The Agency will ensure the industry notifies it of shortages. It will also begin to participate in the coordination initiatives used by the European Medicines Agency (EMA) to facilitate prevention, identification, management and communication of shortages.
The ALMPS will provide a precise regulatory framework for the authorisation and control of the activities of companies in the biotechnology sector, including production and marketing, as well as administration of clinical trials.
Read the press release announcing the creation of ALMPS here.