Information about the Falsified Medicines Directive (FMD)

The Medicines Evaluation Board (MEB) cooperates with the Dutch Medicines Verification Organisation (NMVO) to coordinate the implementation of the safety features and to answer questions about the packaging. The NMVO owns the NMVS, the system in which the product number, batch number, expiry date and the unique serial number (‘unique identifier’) is stored. These elements also appear in the 2D data matrix on the packaging. In addition, the product number, batch number and expiry date of the medicinal product must be clearly legible on the packaging.

Marketing authorisation holders including parallel importers who market prescription-only medicinal products in the Netherlands should contribute to the development and maintenance of the NMVS. After 9 February 2019, no products may be released for the market without the features on the packaging. It is also mandatory to upload product information on the European Hub when the products are released.

• For more information, registration and financial contribution, please visit the NMVO website (in Dutch).
• For more information about registering products on the European Hub, please visit the EMVO website.

CONTINUE READING ON english.cbg-meb.nl

Category:Pharma, Packaging, Classification and Labelling, Regulatory