Any biotechnology company wishing to market and sell their products in the European Union (EU) must first obtain approval from the European Medicines Agency (EMA). This process can be a complicated and lengthy one, but one aspect of this process that is commonly not given enough consideration is the translation of regulatory and patient facing materials into all official EU languages. This makes obtaining accurate, consistent and authoritative translation services essential to successfully exporting your drug, device or product to the EU.
Required submission of regulatory affairs into official EU languages
Regulatory and informational texts related to your product must be evaluated in English by the EMA to ensure compliance with strict guidelines and criteria set by the agency’s Quality Review of Documents (QRD) working group and the appropriate scientific committees within the EMA. The entire process is referred to as the centralised marketing procedure and can take up to 210 active days for an opinion on approval to be reached. This opinion is passed on to the European Commission which grants a single marketing authorization which allows you to sell and market your product in all EU countries as well as the European Economic Area (EEA).
In order to receive approval for the commercialization of your product in the EU, you will need to present your product documentation in all official EU languages to the EMA for review after an opinion is reached. The documentation required includes:
- Summary of Product Characteristics (SmPC)
- Patient Information Leaflets (PIL)
- Labelling and Packaging
- Marketing Authorization Dossiers
- Expert Reports
- Validation Protocols
While the EMA’s centralized marketing procedure is not the only path to selling medicinal products in the EU, it is a requirement for any drug or product made from biotechnology processes. It is also required for products meant to prevent, treat or help diagnose certain diseases such as cancer, diabetes, auto-immune dysfunctions, HIV and any orphan medicines used for rare, life threatening human diseases. You can see the EMA’s website for further details.
Expertise makes a difference
When choosing a Language Service Provider (LSP) to translate your documentation it is essential to select an agency with previous experience in the biotech and life sciences sectors and an expert grasp on the stringent regulatory requirements involved in the approval process set by the EMA. A certified quality management system is important as well, so make sure the LSP you choose has an ISO 9001:2008 certification. The Translation People can offer all these requirements and more, including the use of cutting edge translation technology that ensures cost savings as well as consistency and accuracy in the translation process.
If you have any additional questions, don’t hesitate to contact us through our website or your account manager.