Where the MAH or Manufacturer has a separate WDA, how will packs be decommissioned?

Each Manufacturer who also holds a WDA needs to review their business operations and wholesaling processes and, where applicable, connect to SecurMed for medicines verification and decommissioning as a Wholesaler. 

It is up to each MAH or Manufacturer to perform this assessment.

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EU Exit and UK MVS

The United Kingdom formally departed from the European Union on 31st January 2020, entering into a Transition Period lasting until 31st December 2020.

First Login to UK MVS - Quick Start Guide - Step 1

Ready to log in to the UK MVS?  Please follow the links to instructions below.

Should we contact SecurMed to infiliate to GS1?

No. Please contact GS1 directly.

Does Article 37(d) require that a National Medicine Verification Organisation (NMVO) directly alerts the relevant national competent authorities, the EMA and the Commission about a falsification? Is there is a time limit for such alerting?

The use of the term “provide for” in Article 37(d) of Commission Delegated Regulation (EU) 2016/161 means that an NMVO has to ensure that the National Competent Authorities (NCA), the EMA and the Commission are informed.

Where can I find a copy of the Delegated Regulation?

You can find the Delegated Regulation here.

Which medicines are in scope of FMD?

For details of the scope of the regulation please check: FMD Delegated Regulation 2016_161

Where stakeholders are unclear on the legislation, for example whether types of medicine are in/out of scope, please contact DHSC/MHRA at fmd. safetyfeatures@mhra. gov. uk.