Labeling and packaging of medicinal products for human use: guidelines updated

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.

Etiquetage et conditionnement de médicaments à usage humain : mise à jour des directives

Les titulaires d’autorisation de mise sur le marché d’un médicaments à usage humain doivent respecter certaines directives concernant l’étiquetage et le conditionnement. Ces directives viennent d’être mises à jour.

Les directives « Étiquetage des médicaments » appliquées lors d’une nouvelle autorisation de mise sur le marché (AMM), d’un renouvellement ou d’une variation d’un médicament à usage humain, ont été mises à jour. Les directives sont maintenant adaptées aux directives européennes et à d’autres conventions nationales ou internationales.

Les principales modifications concernent :

  • les sections 16, 17, 18 et 19 du texte de conditionnement selon le template QRD ;
  • la définition de petits conditionnements ;
  • la définition et la soumission de mock-ups ;
  • l’utilisation de marques commerciales, de symboles ® et TM ou de l’indication « marque de » ;
  • l’utilisation de logos et de codes QR ;
  • l’étiquetage de conditionnements combinés et étiquetage de médicaments homéopathiques.

Etikettering en verpakking van geneesmiddelen voor menselijk gebruik: richtlijnen bijgewerkt

De houders van een vergunning voor het in de handel brengen van een geneesmiddel voor menselijk gebruik moeten bepaalde richtlijnen volgen voor de etikettering en verpakking. Deze richtlijnen werden nu bijgewerkt.

De richtlijnen “Etikettering van geneesmiddelen” toe te passen in het kader van een nieuwe vergunning voor het in de handel brengen (VHB), een hernieuwing of een variatie van een geneesmiddel voor menselijk gebruik werden bijgewerkt. De richtlijnen zijn hiermee aangepast aan de Europese richtlijnen en andere nationale of internationale afspraken.

De voornaamste wijzigingen betreffen:

  • sectie 16, 17, 18 en 19 van de verpakkingstekst volgens de QRD-template;
  • definitie van kleine verpakkingen;
  • definitie en indiening van mock-ups;
  • gebruik van handelsmerken, symbolen ® en TM  of vermelding “merk van”;
  • gebruik van logo’s en gebruik van QR-codes;
  • etikettering van combinatieverpakkingen en etikettering van homeopatische geneesmiddelen.

Safer Europe Without Falsified Medicines – Talinn conference November 8-9, 2017

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

read more

Registration for Marketing Authorisation Holders – Wave 2 open

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.

Registration for Marketing Authorisation Holders – Wave 2 open

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.

Joint Declaration Riziv/Inami – Fagg/Afmps – BeMVO

                                                   

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, …

agreement fagg_riziv_bemvo

Annex1-ScopeMatrix

Annex2-PackageDesign

Launch of the EMVO On-Boarding Partner Portal (OBP Portal)

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.

Launch Announcement Letter of the EMVO On-boarding Partner Portal