The Falsified Medicines Directive (FMD), the new EU system to protect patients from fake medicines, went live across the UK and Europe on 9 February.
From now on, the industry will have to affix a 2-D barcode and an anti-tampering device on the box of prescription medicines. The pharmacies , including online pharmacies, and hospitals will have to check the authenticity of medicines before dispensing to patients.
This is the final step in the implementation of the Falsified Medicines Directive, adopted in 2011, aiming at guaranteeing the safety and quality of medicines sold in the EU.
“While some more work will need to be done after the launch of the system to make sure that the new system functions properly across the EU, I am positive that we are providing another safety net for citizens to protect them from the dangers of unauthorised, ineffective or dangerous medicines”, said Vytenis Andriukaitis, EU Commissioner for Health and Food Safety.
However, authorities in the UK said they will take a ‘pragmatic’ approach on the implementation of safety regulations.
“We recognise that not all pharmacies will be meeting the legal obligations of FMD straight away. We intend to take a pragmatic and proportionate approach to the implementation of the new safety features,” said Duncan Rudkin, Chief Executive of the General Pharmaceutical Council in a statement.
“When inspecting a pharmacy, our inspectors would consider all of the relevant evidence, including whether the pharmacy had a clear plan in place to meet all of the requirements of FMD, before deciding whether or not the relevant standard had been met,” Rudkin added.
The future of the new system in the UK is predicated on the nature of Brexit as there are fears that the country will be dropped out from the system of in the event of a no-deal.
“It would be an absolute travesty if NHS patients aren’t part of a system specifically designed to protect them. But that’s exactly what could happen in a ‘no deal’ Brexit,” warned Rick Greville, director of supply chain at the Association of the British Pharmaceutical Industry.
At present, there are not many FMD-compliant packs in pharmacies and the medicines produced before Saturday 9 February 2019 without safety features may also remain on the market until their expiry date.
MHRA, in its latest guidance on 7 February, advised pharmacies to ensure supply of medicines goes unhindered despite the anticipated initial glitches.
“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 guidance noted.
The agency also said it will take a “pragmatic, flexible approach” on the enforcement, as long as the normal checks are carried out.
The UK FMD working group for community pharmacy has issued an interim guidance on dealing with FMD alerts.