Is there further guidance on False Negatives – out of date, recalled pack, status error, data error, etc?

Several groups, including FMD Source, SecurMed UK and others, are working on establishing guidance for the various stakeholders. This guidance will be communicated in due course.

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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.

Will Community/Hospital Pharmacies be able to return stock to their Wholesaler or a DTP manufacturer’s distributor?

This depends upon the terms and conditions of both the Wholesaler and the manufacturer. However, in general, we expect the current returns process will remain valid as long as the stock has not been decommissioned and the anti-tamper device is still intact.

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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.

Is Gibraltar in scope of the FMD implementation and what about British Crown Dependencies and British Overseas Territories?

MHRA have confirmed with the UK Foreign Office that the Crown Dependencies of Jersey and Guernsey (including the other Channel Islands) and the Isle of Man are included within the FMD implementation. Gibraltar and all other British Overseas Territories e. g.

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