Interim guidance on FMD alerts published

The final phase of FMD implementation begins on 9th February 2019. FMD is a huge project and it is important that during the initial period, medicines are not unreasonably withheld from patients, unless there is a high degree of suspicion that the pack might be falsified.

At present, there are not many FMD-compliant packs in pharmacies. We also know that some generic medicine packs that have a 2D data matrix are not actually FMD-compliant packs (one indication of this is that they do not have an anti-tampering device). If you scan them the system will generate an alert.

In the initial phase of implementing FMD, many “false positive” alerts are expected; this does not necessarily indicate a falsified medicine, and in most cases it will be appropriate to dispense the medicine, subject to the normal checks. The alerts will reduce in number as more of the packs reaching pharmacy are FMD-compliant.

The UK FMD Working Group for Community Pharmacy has today (7/2/19) published interim guidance for pharmacy teams on dealing with FMD alerts generated when products are scanned.


New MHRA guidance

The MHRA issued the following guidance on 7th February 2019:

Guidance on safety features: 7 February 2019

The United Kingdom is committed to meeting the 9 Feb 2019 deadline for the launch of EU FMD safety features Delegated Regulation, and we expect all stakeholders in the UK supply chain to be aiming to comply with these new requirements, indeed we know much of the UK supply chain is already prepared.

Despite the significant work undertaken to date in the UK and given the complexities associated with setting up the medicines verification system across the EU it is anticipated issues will arise especially during the initial operational/implementation phase. It is important that these issues do not compromise confidence in the medicines supply chain. The Government’s priority is the continued supply of safe medicines to patients.

For example, several Member States have formally advised those who may receive ‘unknown’ error messages to dispense anyway. Therefore, the MHRA will also be taking a pragmatic, flexible approach to how we enforce the new legal requirements, as long as the normal checks are carried out, and there is no reason to think that the medicine is falsified. This position will be kept under review.

We are also aware of issues around non-FMD compliant packs released to market before 9 February 2019, and wholesalers’ designated status, We will continue to work with UK stakeholders to help bring them into full compliance with the safety features regulation as soon as possible.

https://www.gov.uk/guidance/implementing-the-falsified-medicines-directive-safety-features#history

Roles of the regulators as FMD comes into force: GPhC & MHRA statement

The MHRA and General Pharmaceutical Council (GPhC) have today (17th January 2019) published a joint statement on their respective roles in relation to the enforcement of the FMD legislation in England, Scotland and Wales.

The GPhC will use its existing inspection processes to assess whether pharmacies are meeting its standards. For those registered pharmacies that are found not to have met the standards for registered pharmacies, and where a contributing factor relates to breaches of the new safety feature provisions, the GPhC will use its regulatory powers, including improvement action plans, to make sure that pharmacies take action to meet the standards and requirements under legislation.

The MHRA is responsible for making decisions on and instigating any enforcement action in relation to the safety features legislation, which may include seeking compliance, enforcement notices or, as a last resort, criminal prosecution for the most serious, persistent breaches.

The GPhC and the MHRA will share information, as appropriate, to ensure that the purpose of the legislation is met and that medicines supplied from registered pharmacies are safe for the public to use.

Read the full joint statement