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.
The European Commission published an update of the FAQ document “Safety features for medicinal products for human use”. You can find this document in our FAQ section.
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, …
The European Medicines Verification Organisation (EMVO) is pleased to announce that the EMVO On- boarding Partner Portal (OBP Portal) is up and running. To facilitate the on-boarding of pharmaceutical companies to the EU Hub, the user-friendly web-based portal will guide pharmaceutical companies step by step through the process.
The FAMHP is following the implementation plan from CMDh/EMA where the notification of the safety features can be included in each newly introduced filing with impact on the product information (five-yearly renewal, IA, IB or II variation) by using the updated version of the QRD template. The company pays the fee of the initial file without any additional cost for the implementation of the safety features.
Besides the QRD, also the mock-up must be adapted. The mock-up can also be included in the file without an additional cost. The mock-up must only be submitted if the implementation of the safety features has an impact on the readability.
For medicines using the national procedure, the implementation of the safety features can be grouped if the readability of the mock-up is not impacted. The fee for such submission is similar to a grouped IA-variation.