In the conviction that greater collaboration between Member States will improve access to medicinal and health products, Belgium and the Grand Duchy of Luxembourg have formalised their joint declaration of 4 July 2016 (Gäichel IX) with a cooperation agreement aimed at deepening their collaboration in this field.
On 17 January 2018, Health Ministers Maggie De Block and Lydia Mutsch signed a cooperation agreement between Belgium and the Grand Duchy of Luxembourg aimed at deepening their collaboration in the field of medicinal and health products.
Maggie De Block, Belgian Federal Minister of Social Affairs and Public Health: ‘Thanks to the rigorous oversight of the FAMHP, our agency with competence in matters of medicinal and health products, Belgian patients can count on quality, safe, effective medicinal products. This guarantee for the patient has now been strengthened: by collaborating more closely with the Grand Duchy of Luxembourg and, for example, by exchanging more information between us, the FAMHP will be able to intervene faster than ever, if necessary.’
This agreement covers:
- market oversight throughout the full life cycle of medicinal and health products;
- inspections in all of the areas covered;
- oversight of clinical investigations, studies and tests;
- file evaluation;
- exchanges of expertise, resources and information;
- activities relating to medicinal products, medical devices and human body tissue of human origin (blood, cells and tissues).
Concerning medicinal products, the cooperation agreement notably provides for information exchange concerning JAP (Joint Audit Program) audits in the field of medicinal product manufacture. These are audits mandated by the European Commission that are intended to ensure that best manufacturing practices are applied in a harmonised manner and at a high-level. As the Minister of Health of the Grand Duchy of Luxembourg, Lydia Mutsch, emphasised: ‘The end goal is for all patients to have swift access to quality medicinal products. Systematic collaboration with the Belgian Federal Agency for Medicines and Health Products, which has excellent skills in the field, will effectively make it possible to guarantee consistent quality in the inspections; this will in turn also contribute to the attractiveness of Luxembourg as a site for pharmaceutical activities.’
The agreement also provides for: joint inspections in this field to be performed by Belgian and Luxembourg teams on Luxembourg territory; field training for Luxembourg inspectors, delivered by experienced Belgian inspectors; exchanges concerning the RAS (Rapid Alert System), which supervises the withdrawal of non-compliant batches of medicinal products; exchanges of information concerning market oversight programmes supported by analyses of medicinal products.
Exchanges and coordinated inspections of cross-border players, regarding medical devices, are also provided for.