Chemist + Druggist is part of Informa PLC


This site is operated by a business or businesses owned by Informa PLC and all copyright resides with them. Informa PLC’s registered office is 5 Howick Place, London SW1P 1WG. Registered in England and Wales. Number 8860726.


This copy is for your personal, non-commercial use. Please do not redistribute without permission.

Printed By

UsernamePublicRestriction

Multiples question relevance of EU medicines scanning law post-Brexit

The organisation representing the largest multiples has questioned how long an EU scanning law will be relevant after the UK exits the European Union.

The Falsified Medicines Directive (FMD) will require every pharmacy in the UK to scan barcodes and check tamper-proof devices from February 9, 2019 – less than two months before the UK is due to leave the EU, on March 29.

The Company Chemists’ Association (CCA) – which represents the UK’s largest multiples – said it was “inevitably difficult to respond” to a Medicines and Healthcare products Regulatory Agency (MHRA) consultation on implementing the directive, “in the context of significant uncertainty arising from the UK exiting from the EU”.

CCA chief executive Malcolm Harrison said last Friday (September 21): “Pharmacy businesses…do not know how long they will have access to the FMD system, because we do not know what agreement the UK government and the European Union will come to.”

“In this situation of uncertainty, pharmacy businesses are nevertheless having to enter into legal agreements and make financial investments in IT, staff training and other operationalisation platforms with FMD system suppliers, despite not knowing if they will be required on an ongoing basis,” he added.

The CCA also stressed the government should compensate the sector if the process of verifying medicines in the UK becomes disconnected from the EU's system and the FMD becomes redundant.

It called for “clarity and certainty” on the longevity of the FMD after Brexit “as soon as possible”.

Civil sanctions for non-compliance

In July, the government proposed “the sole use of criminal sanctions for failure to comply” with the FMD, in the form of “an unlimited fine...or imprisonment for a term not exceeding two years, or both”.

However, the CCA argued that apart from serious cases – such as wilful non-compliance or fraud – civil sanctions should be applied.

“We would not expect a punitive legal approach to any instances of non-compliance in the early stages of implementation, but rather we call for an opportunity for local, company-level and system-wide learning,” the CCA said.

Brexit must not disrupt supply chain

The CCA also said the FMD must not disrupt the pharmacy supply chain, to “ensure patients still get their medicines on time”.

“Our priority for FMD is to ensure patient safety and integrity of the supply chain are maintained as the UK leaves the EU,” Mr Harrison added.

Is your pharmacy prepared to comply with the FMD in February?

Related Content

Topics



Pharmacy Dispenser/ Technician
Bethnal Green North, London
Salary: Up to £30,000

Apply Now
UsernamePublicRestriction

Register

CD005536

Ask The Analyst

Please Note: You can also Click below Link for Ask the Analyst
Ask The Analyst

Thank you for submitting your question. We will respond to you within 2 business days. my@email.address.

All fields are required.

Please make sure all fields are completed.

Please make sure you have filled out all fields

Please make sure you have filled out all fields

Please enter a valid e-mail address

Please enter a valid Phone Number

Ask your question to our analysts

Cancel