Regulatory Affairs

Quality translations, adherence to deadlines, and a thorough understanding of the pharmaceutical industry are pre-requisites for Marketing Authorisation Applications (MAAs), whether processed using mutual recognition or centralised procedures. Translations of all documents - including SmPCs, PILs, labelling, patient informed consent forms etc. - need to adhere to EU guidelines, including those of readability.

In the case of product information for filing with the EMEA, we provide translations of the texts from their earliest versions through to any updates and amendments required for variations and renewals, using the same team of translators to ensure consistency and within the specified EMEA deadlines.

The languages requested for these purposes include all those of the European Economic Area (including Icelandic and Norwegian), together with Japanese, Chinese, Afrikaans and Hebrew, among others.

Here is a selection of links related to Regulatory Affairs that our clients have found useful:

• How to generate PDFs
• The guideline on SPCs
• The readability guideline
• The QRD convention for templates
• The annotated template (English)
• The linguistic review process
• The timetable for evaluation of the MAA
• The introduction to PIM

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