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Falsified Medicines Directive

FMD regulations won’t apply after ‘no-deal’ Brexit, says MHRA

Regulations coming into force as part of the Falsified Medicines Directive will not apply to the UK if it leaves the EU without a deal, the Medicines and Healthcare products Regulatory Agency has announced.

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Source: Jonathan Buisson / UK FMD Working Group

Anti-tamper and authentication regulations being implemented under the Falsified Medicines Directive will not apply in the case of a no-deal Brexit, the MHRA has said

Pharmacies will have no legal obligation to implement the Falsified Medicines Directive (FMD) in the event of a ‘no-deal’ Brexit, the Medicines and Healthcare products Regulatory Agency (MHRA) has confirmed.

The medicines safety regulator said that in the “unlikely event” of no deal being agreed with the EU, the legal obligation to adhere to the FMD regulations “would be removed for actors in the UK supply chain”.

The announcement comes after talks between pharmacy negotiators and the government, which revealed that there would be no guarantee of additional funding for pharmacies to implement FMD before negotiations over the 2019/2020 community pharmacy contract begin.

The FMD is scheduled to go live on 9 February 2019 — weeks before the UK is due to leave the EU on 29 March 2019.

The MHRA announced in a consultation document, published on 4 October 2018, which looked at medicines regulation in the event of a no-deal Brexit with no implementation period, that the FMD would be revoked in the UK.

The document says: “In the unlikely event of no deal being agreed with the EU before 29 March 2019, we expect the UK would not have access to the EU central data hub, and therefore stakeholders would be unable to upload, verify and decommission the unique identifier on packs of medicines in the UK.

“Therefore, the legal obligation related to this would be removed for actors in the UK supply chain.”

Claymore Richardson, senior policy manager at the Department of Health and Social Care, told delegates at the Pharmacy Show, which was held in Birmingham on 7 October 2018, that although the FMD would no longer apply, it would still be “common sense” to build on work already done to create a UK version of the FMD.

If the UK left the EU with a long-term agreement in place, the FMD regulations would continue as normal, and if there was no agreement but a transition period, there would be “20 months of short-term certainty”, he said.

Richardson also told the audience that community pharmacists would not face stand-alone FMD compliance inspections, and that checks on FMD compliance would be incorporated into inspections by the General Pharmaceutical Council, Care Quality Commission and other relevant bodies.

Also speaking at the Pharmacy Show, Simon Dukes, chief executive of the Pharmacy Services Negotiating Committee (PSNC), told delegates that he had been told by the government that funding for FMD implementation would not be confirmed until talks over a new community pharmacy contract begin.

Dukes told the audience that although he had met with pharmacy minister Steve Brine, the PSNC did not yet even have an agreement for 2018/2019 and that contact between the government and the PSNC so far had been to “keep the show on the road”.

He said he was hopeful that discussions over the 2019/2020 contract would begin “in the next month”.

Rick Greville, a director of both SecurMed and the Association of the British Pharmaceutical Industry, also told delegates that community pharmacists would be able to connect to the FMD UK hub from 28 October 2018.

Citation: The Pharmaceutical Journal DOI: 10.1211/PJ.2018.20205559

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