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Belgium Takes Final Steps to Formalise Cooperation with Luxembourg on Surveillance of Medicines and Health Products

  • 04/01/2023
  • News

On 27 December 2022, the Belgian Official Journal published a Law of 7 November 2022 giving assent to the Cooperation Treaty between the Kingdom of Belgium and the Grand Duchy of Luxembourg regarding Medicines and Health Products, as signed in Luxembourg on 17 January 2018 (the Treaty) (Wet van 7 november 2022 houdende instemming met het Samenwerkingsverdrag tussen het Koninkrijk België en het Groothertogdom Luxemburg inzake geneesmiddelen en gezondheidsproducten, gedaan te Luxemburg op 17 januari 2018/Loi du 7 novembre 2022 portant assentiment à la Convention de coopération entre le Royaume de Belgique et le Grand-Duché de Luxembourg en matière de médicaments et de produits de santé, faite à Luxembourg le 17 janvier 2018 – the Law). The Law is accompanied by the text of the Treaty, which, according to the Law, entered into force on 28 November 2022 (see, attached copy).
The Treaty intends to regulate cooperation between Belgium and Luxembourg in the fields of medicines, medical devices and blood, cells and tissues of human origin. Its main purpose is to allow for the participation of Belgian inspectors in inspections in Luxembourg to monitor compliance with the applicable regulatory framework, including Good Manufacturing Practices (GMP) and Good Distribution Practices, until Luxembourg will be able to deploy own inspectors for these purposes. Until recently, Luxembourg did not have its own GMP inspectors as there was no medicines manufacturing activity on its territory. The country’s decision to establish a national medicines agency that is separate from the executive branch of government is as recent as December 2019 (see, Van Bael & Bellis Life Sciences News and Insights of 6 January 2020).
While the Law was adopted by the Chamber of Representatives on 28 April 2022, it took until 7 November 2022 for it to be promulgated by the King. Moreover, the Law’s subsequent publication in the Belgian Official Journal did not happen until 27 December 2022. We are unsure about the reasons for this drawn-out process.

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