Time to update your veterinary product information?

From the “new” Veterinary Medicinal Products Regulation (Regulation (EU) 2019/6) came into force on 28 January 2022, the QRD template v.9 has been obligatory for all MA applications.

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 […]

Are your cosmetic products compliant with the applicable legislation?

The Norwegian Food Safety Authority (NFSA) has announced that they, in 2023, will perform audits of manufacturers/importers/distributors of cosmetic products to the Norwegian market. They want to assess if companies comply with the requirements in the cosmetic regulations, including requirements for product claims1. Mericon has more than 30 years’ experience within regulatory affairs and compliance, […]