FAMHP guidelines for implementing the safety features in line with the Falsified Medicines Directive 2011/62/EU of the European Parliament and of the Council
- For the implementation of the safety features on the packaging (Quality Review of Documents - or QRD-template) for medicinal products for the Belgian market, the FAMHP follows:
- The implementation plan of the European Medicines Agency (EMA) for centrally authorised medicinal products;
- The implementation plan of the Coordination Group for Mutual Recognition and Decentralised Procedures - Human (CMDh) for medicinal products authorised via the Mutual Recognition Procedure (MRP), the Decentralised Procedure, (DCP) and the national procedure.
- For the implementation of the safety features on the mock-up (= flat design, in colour with the final font and the final font size, providing a clear representation of the three-dimensional presentation of the packaging) for medicinal products for the Belgian market, the company conducts an impact analysis of the implementation of the 2-D matrix barcode and the anti-tampering device on the legibility of the mock-up.
- If the company's analysis shows that the implementation will have no significant impact (e.g. because the 2-D matrix barcode replaces the CNK code and there are no further changes to the existing packaging), then the company does not need to provide the FAMHP with the mock-up. The company will add a declaration to the dossier indicating that this implementation has no significant impact on the mock-up.
Standard text for the declaration
The undersigned [name of the person responsible for the information, company name] declares that the implementation of the safety features (the unique 2-D matrix barcode and the anti-tampering device) have no impact on the legibility of the mock-up, most recently approved by the FAMHP, of [name of medicinal product]. The undersigned bears full responsibility for this.
- If the company's analysis shows that the implementation of the safety features will certainly have an impact on the legibility of the mock-up, then the company will provide a mock-up proposal so that it can be evaluated by the FAMHP. The mock-up will be submitted to the FAMHP via the dossiers with a significant impact on the closure documents (variation type II clinical, variation type IB clinical, five-year renewal or RQ) or via a separate notification art. 34§4 (see also national Q&A).
- Additional information: