Belgium - Royal Decree Amends Various Decrees on Medicinal Products and Medical Devices

• 26/12/2023
• News

On 7 December 2023, the Belgian Official Journal (Belgisch Staatsblad / Moniteur belge) published a Royal Decree of 23 November 2023 modifying various Decrees on medicinal products and medical devices (Koninklijk Besluit van 23 november 2023 tot wijziging van diverse besluiten inzake geneesmiddelen en medische hulpmiddelen / Arrêté royal du 23 novembre 2023 modifiant différents arrêtés en matière de médicaments et dispositifs médicaux – the RD).
 
Here are the principal changes which the RD brings about: 

• The RD amends Article 13 of the Royal Decree of 7 April 1995 on information and promotion of medicinal products for human use with a view to allowing marketing authorisation holders to appoint holders of a master’s degree in pharmaceutical sciences as their “responsible person for information” (verantwoordelijke voor de voorlichting / responsable de l'information). Thus, this role is no longer reserved to licensed pharmacists and physicians. Further, the RD modifies the composition of the “Supervisory Commission for advertising of medicinal products” (Commissie van Toezicht op de reclame voor geneesmiddelen / Commission de Contrôle de la publicité des médicaments) (Articles 1 and 2, RD). 
• The RD reinstates certain provisions governing clinical investigations of (i) the Royal Decree of 18 March 1999 on medical devices (implementing Council Directive 93/42/EEC, which was repealed by the Medical Devices Regulation (Regulation (EU) 2017/745; MDR)); and (ii) the Royal Decree of 15 July 1997 on active implantable medical devices (implementing Council Directive 90/385/EEC, which was repealed by the MDR) (Articles 3-8, RD). The reinstated provisions were repealed by Royal Decree of 13 September 2022 (see, Van Bael & Bellis Life Sciences News and Insights of 26 October 2022), but that repeal took place prematurely and is now undone. This is because pursuant to Article 120(11), MDR, “[c]linical investigations which have started to be conducted in accordance with Article 10 of Directive 90/385/EEC or Article 15 of Directive 93/42/EEC prior to 26 May 2021 may continue to be conducted [after that date]”, in which case these investigations remain subject to the requirements of Council Directives 90/385/EEC and 93/42/EEC (and, thus, the Royal Decrees of 15 July 1997 and 18 March 1999), except for the reporting of serious adverse events and device deficiencies which should be carried out in accordance with the MDR. 
• The RD reinstates certain provisions governing performance evaluations of the Royal Decree of 14 November 2001 on in vitro diagnostic medical devices (implementing Directive 98/79/EC, which was repealed by the In Vitro Diagnostic Medical Devices Regulation (Regulation (EU) 2017/746; IVDR)) (Articles 9 and 10, RD). Although the IVDR is applicable to performance evaluations that were initiated before its entry into force on 26 May 2022, the provisions of Directive 98/79/EC (and, thus, the Royal Decree of 14 November 2001) remain relevant because Directive 98/79/EC requires manufacturers to keep available, for a period ending at least five years after the end of the performance evaluation, the documentation allowing an understanding of the design, manufacture and performances of the product, including the expected performances, so as to allow assessment of conformity with the requirements of this Directive by the competent national authorities (i.e., in Belgium, the Federal Agency for Medicines and Health Products (FAGG / AFMPS – FAMHP). 
• The RD gives binding force to the European Guidelines of 19 March 2015 “on principles of Good Distribution Practice of active substances for medicinal products for human use” (OJEU, 21 March 2015, C95/1) by adding a reference to these Guidelines in new Article 81, §3 of the Royal Decree of 14 December 2006 on medicinal products for human and veterinary use (RD of 14 December 2006) and enclosing them to the RD of 14 December 2006 as new Annex IVquinquies (Articles 12 and 13, RD). 
• The RD amends Article 95, §2 of the RD of 14 December 2006 to clarify that bio-engineers and holders of a master’s degree in bioengineering can act as the responsible person of a wholesale authorisation holder (Article 14, RD). 
• In the area of clinical trials with medicines for human use, the RD provides that the Clinical Trial College (and no longer the FAMHP) is responsible for requesting additional information from the sponsor and for extending the assessment period in relation to Part II of the report when Belgium acts as Member State concerned or new Member State concerned in the context of an application for authorisation, subsequent addition or substantial modification of a clinical trial (Article 16, RD); 
• The RD amends (i) the Royal Decree of 12 May 2021 implementing the Law of 22 December 2020 on medical devices; and (ii) the Royal Decree of 14 September 2022 implementing the Law of 15 June 2022 on in vitro diagnostic medical devices with a view to clarifying that not only the Minister for Public Health, but also his delegate (namely the administrator-general or other staff members of the FAMHP) can take preventive measures to protect health in the context of market surveillance (Articles 17, 18, 33 and 34, RD). 
• The RD amends the Royal Decree of 18 May 2021 on clinical investigations of medical devices, in particular to replace the notion of an “application for a substantial modification” with that of a “notification of a substantial modification”, in line with the terminology used in the MDR (Articles 19-32, RD). 

The RD entered into force on 17 December 2023.
 
Attached is a copy of the RD and of the Council of State’s related opinion of 18 October 2023.