FMD - Medicines without marketing authorisation

Since the FMD (Falsified Medicines Directive) was introduced on February 9, 2019, Farmalogg has, in accordance with current arrangements, registered whether a medicine with marketing authorization (MA) has been subject to the directive. Medicines without MA has until recently not been registered in Vareregisteret in accordance with the directive, due to a transitional agreement.

The transitional agreement expired on January 15, 2022, and from the same date, medicines without MA have been subject to verification via the EU hub in the same way as medicines with MA. As a result, starting from March 1, 2022, Vareregisteret will state whether a medicine without MA is covered by the directive.

FMD “Yes”/”No” in VareWeb

All medicines without MA must be registered with FMD “Yes”/ “No” in VareWeb, according to the directive. From February 15, 2022, VareWeb will include a new field in the registration of new products so that you must enter FMD “Yes”or ”No” when you submit new medicines without MA. The company is responsible for entering correct information according to FMD.

Product codes

In order for a pharmacy to scan 2D code in connection with FMD, it is critical that you register the product code(s) at Farmalogg. It is not sufficient that the product code is registered in the EU hub.

For new products that are registered with a product code, you must attach a mock-up or equivalent documentation of the product code to the enrollment.

New product codes

You must register the product code in VareWeb before the package with the new product code is delivered to the wholesalers/pharmacies, and you must attach a mock-up to document the product code. For further description of the procedures and documentation, see FAQ on Registering a new product code/barcode.

Published: 15.02.2022
Farmalogg AS | Slemdalsveien 1 | Postboks 5070 Majorstuen | 0301 Oslo | Tlf: +47 21 62 02 00 |
Privacy statement Copyright © 2014