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

General information:

  1. 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:

 

  1. 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:

European Q&A

Supplement to European Q&A 1.20 ‘Safety features for medicinal products for human use - questions and answers’

The FAMHP recommends repackaging of medicinal products in the case of parallel import and parallel distribution. A new ATD can only cover up the existing ATD in exceptional cases and only with the explicit approval of the FAMHP.

Article 79 bis of the Royal Decree on medicinal products for human and veterinary use of 14 December 2006 states that the replacement of the safety features must be reported to the FAMHP.

  • In the case of parallel import, this is done by approving the packaging via a variation in accordance with the Royal Decree on parallel imports of medicinal products for human use and parallel distribution of medicinal products for human and veterinary use of 19 April 2001.
  • In the case of parallel distribution, the FAMHP expects that a sample of the packaging (original and new) is submitted to the Marketing Authorisation Division (variations and renewals) of the DG POST authorisation. By submitting a sample of the packaging (original and new) as soon as possible after obtaining the authorisation for parallel distribution of the EMA, you can avoid that a control afterwards would show that the new ATD is insufficient equivalent to the original, what could result in the recall of the medicinal product.

National Q&A

Last updated on 13/06/2019