Will anti-tamper devices be allowed on OTCs and other out-of-scope products after February 2019?

The MHRA has confirmed that subject to the outcome of a public consultation anti-tamper devices may continue to be placed on out-of-scope products after 9th February 2019 if the relevant manufacturer considers that it is necessary to do so in the interests of patient safety.

Similarly, anti-tamper devices may be placed on new out-of-scope products introduced to the market after February 2019, based on a similar risk assessment and on a voluntary basis.

All of which are subject to MHRA approval.

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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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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.

Where can I find a copy of the Delegated Regulation?

You can find the Delegated Regulation here.