High quality Norwegian product information

High quality Norwegian product information

The Norwegian Medicines Agency (NoMA) strongly encourages marketing authorisation holders (MAH) to focus on high quality translations of product information (PI):

The product information has to be easy to read and understand for the users. A higher quality of the product information will improve the patient information and contribute to safe use of medicines. There should be a focus on readability and a consistent and harmonized language”.

“It is important that the translated Norwegian text has the same meaning as the English text (faithful translation). There are differences between English and Norwegian grammar. Sentence structure and word order are often different. Direct translation from English to Norwegian can lead to complicated wording and incorrect translation.”

Mericons’ experienced regulatory team performs high quality PI translations, updates and reviews in line with current European and Norwegian templates, guidelines, and other resources. We focus on using up-to-date medical terms and commonly used wording and technical terminology that health care personnel are familiar with. It’s also important to us to use patient friendly language in leaflets and instructions intended for the patients.

Whether you need support for a single assignment, assistance during holidays or a long term local regulatory partner, do not hesitate to contact our regulatory team.