FMD and VareWeb

FMD (Falsified Medicines Directive) was introduced February 9, 2019. Since that date, there has been a transitional agreement where Farmalogg has registered FMD “Yes” for medicinal products with marketing authorization (MA) in accordance with packages registered in the EU hub and passed on to NMVS (Norwegian Medicines Verfication System)

The transitional agreement expires on April 1, 2021, and from the same date, medicines with MA will be registered in Vareregisteret according to the directive.

 

 FMD “Yes”/”No” in VareWeb

All medicines with MA must be registered with FMD “Yes”/ “No” in VareWeb, according to the directive. From March 16, 2021, 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 with 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 new product code at Farmalogg. This applies even if you have entered the product code in the EU hub

 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; https://www.farmalogg.no/en/Infomasjonssider-folder/FAQ-info-sider/Registering--new-product-codebarcode/

Published: 16.03.2021
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