Transposition of FMD into UK Law

Today saw the amendment to the Human Medicines Regulations come into force following the falsified medicines directive (2011/62/EU).  This was the first time that the UK missed a deadline for transposition of EU directives and I covered this in detail in a previous post.
As of today written confirmations for API importation from 3rd countries is now a legal requirement in the UK.  The only aspect remaining of the FMD that requires transposition is the introduction of safety features & associated serialisation.

Aside from the obvious inclusion of brokers, GDP, wholesaling, API importation, QP declaration etc there are a couple of additional points to consider that may have flown under the radar:

• MHRA Guidance on FMD

The MHRA have a comprehensive section of their website dedicated to the implementation of the FMD.   This section covers all you need to know about the 4 main pillars of the FMD and provides an excellent training resource for your law & admin revision.

• New Prescribers

The updated legislation has extended the scope of independent prescribing.  independent prescribers are allowed to prescribe specific medications without the supervision of a doctor or dentist and previously this privilege was limited to specialist nurses, optometrists & pharmacists.  As of today physiotherapists and podiatrists will be able to become independent prescribers.  These independent prescribers can also mix, sell or supply certain medicines.

Why is this important to QPs?  Well, prescribers directly influence how your products are used.  Do podiatrists have the knowledge and skills to understand the stability implications for mixing certain medicines?  Do physiotherapists fully understand the potential for complex pharmacological interactions with other medicines?  Pharmacists & doctors are no longer the primary gatekeepers of your prescription only medications.  These new pathways will need to be covered in communication of future recalls.  Also, could these changes lead to a change in the baseline level of complaints received by your PV department?

Summary

New legislation on FMD transposition is finally with us.  It is important to consider the wider implications of new legislation and look beyond the obvious headlines of GDP & written confirmations.  Having this wider appreciation of updates and how they may impact your area of practice is a key skill for the QP.