To market medicinal products in the European Union (EU) countries, pharmaceutical companies must prepare and translate documents like the Summary of Product Characteristics (SmPCs), Patient Information Leaflets (PILs), and product labels in twenty-four (24) EMA-approved languages. A dedicated Working Party (WP) is assigned by the European Medicines Agency (EMA) for Quality Review of Documents (QRD). The WP develops, reviews, and updates templates as per the authority requirements for Marketing Authorization Holder’s (MAH’s) perusal.

The sponsors must submit a Marketing Authorization Application (MAA) to market a product in any of the EU member states via a centralized procedure. The SmPC, PIL, and product labels need to be aligned with the latest template version designed by the QRD. The leaflet inserts of medicines distributed within the EU must use the QRD template and standard texts. The addition of Annex II in the template must be added in the submissions in the twenty-four (24) EU-authorized languages.

What’s New in QRD 10.2 Rev. 1 Template?

The 10.2 rev1 template has been amended to include Northern Ireland in the list of local representatives at the end of the package leaflet. Click here to download the new template.

Members of the Working Party (WP)

The WP acts as a catalyst to streamline the European decision-making process, such as handling product information and ascertaining provisions of guidance and standardization. Doing so ensures that there is no conflict of interest amongst the scientific committees. 

The members of the QRD are nominated by the National Competent Authorities having Regulatory and linguistic competencies. Two (02) members from each member state are assigned, one (01) for human medicinal products and one (01) for veterinary products. Besides, one (01) representative each from the European Commission, the Translation Centre for the Bodies of the European Union (CdT), and the Agency Secretariat participate in the work of the QRD. The Agency chairs the group and provides the support needed by the pharmaceutical companies.

The Responsibilities of the Working Party on QRD Includes:

• Ensuring there is no linguistic ambiguity in the product information
• Comparing the terminologies in the original and translated versions
• Verifying the readability of Product Information (PI) mentioned
• Scrutinizing and updating the QRD templates as and when required to keep up with the EU rules on human medicines
• Assisting the organizations in understanding the importance of adapting the legislations and guidelines in relation to PI and labeling

To keep at par with the changing QRD templates, pharmaceutical companies have to confirm that their existing documentation meets the requirements of the latest version. A seasoned and reliable expert can assist in translating every document into the required languages to comply with the specifications. Since QR templates are sensitive in nature, an experienced translator familiar with EMA’s centralized processes ensures complete accuracy and compliance of such documentation.

Sail through the European Regulatory requirements with translations or updates of SmPCs, PILs, and product labels in accordance with the modified country-specific QRD templates. Reach out to Freyr for labeling compliance.