FAGG/AFMPS has published a communication indicating that the transition period in Belgium will be extended until September 1st.
Reminder from the Belgian Authorities (Medicines Agency) with regards to the Human Readable text next to the 2D matrix code:
The product code (GTIN) must always be preceded by “PC”
The serial number (UI) must always be preceded by “SN”
The Belgian national institute for health insurance RIZIV/INAMI has published new legislation related to the implementation of the Falsified Medicines Directive, more specifically concerning the replacement of the linear unique barcodes with the 2D matrix information (FMD unique codes).
Hereby the related documents:
The Belgian Medicines Verification System is now Live and connected to the European Hub.
Click here to read the press release
The specifications for MAHs regarding the product & pack data to be uploaded on the Belgian repository, covering Belgium and Luxembourg, have been updated. The load of the national code is NO longer mandatory.
Please find hereby the reviewed specifications.
The holders of a marketing authorization for a medicinal product for human use must follow certain guidelines for labeling and packaging. These guidelines have now been updated.
The guidelines “Labeling of medicinal products” to be applied in the context of a new marketing authorization (MA), a renewal or a variation of a medicinal product for human use have been updated. The guidelines are thus adapted to European directives and other national or international agreements.
The main changes concern:
- sections 16, 17, 18 and 19 of the packaging text according to the QRD template;
- definition of small packages;
- definition and submission of mock-ups;
- use of trademarks, symbols ® and TM or mention “brand of”;
- use of logos and use of QR codes;
- labeling of combination packages and labeling of homeopathic medicines.
To participate, please send a mail to firstname.lastname@example.org, with subject tech infosession 6th November
If you already want to connect to the NMVS portal of Arvato Systems, use this link.
Safer Europe Without Falsified Medicines Conference will be held during the period of the Estonian Presidency of the EU Council and supports Estonia’s priorities as the ICT projects leader in Europe.
The aim of the Conference:
- To understand the current state of implementation of the safety features of medicinal products at the European Union level and in Member States
- To identify the challenges for stakeholders and governments in implementing the safety features of medicinal products
- To develop ideas for coping with challenges
The Wave 2 registration to the Belgian Medicines Verification System for Marketing Authorisation Holders is open.
MAHs who register before end December 2017 will benefit from a 25% discount on the registration fee if the payment of the fee is received latest by end January 2018. We invite the MAH’s who desire to register to do so as soon as possible.
Please consult the MAH Registration section on this website for more information on the procedure and download the appropriate documents.
Riziv/Inami and Fagg/Afmps have emitted together with BeMVO a joint declaration confirming and specifying various elements related to the implementation of FMD in Belgium.
The different aspects addressed concern amongst others the starting date, the FMD scope for Belgium , the alignment with Grand Duché du Luxembourg, Instructions for package design and submission of variations, major milestones of the implementation, …