Written Confirmations – confirmed in writing?

This week saw the deadline for written confirmations for APIs imported into the EU from 3^rd countries as part of the measures included within the falsified medicines directive (2011/62/EU).  The FMD states that all APIs imported from 3^rd countries that are not on an approved list (‘White list’) require a written confirmation from the manufacturer’s competent authority for each batch stating the API has been manufactured according to equivalent EU GMP and that the manufacturing site is subject to unannounced inspections.   A template of the written confirmation can be found in EU GMP Part III.  

Legal Basis

As you are aware EU directives are required to be transposed into UK law within a specific time frame.  The FMD is an update to 2001/83/EC which is transposed into UK law via the Human Medicines Regulations 2012 (SI 2012/1916).  SI 2012/1916 was active as of August 2012 and since then no updates to this legislation have occurred (except for an update regarding fees).  As a result, SI 2012/1916 (as it stands on 2^nd July) does not include the requirement for written confirmations.   All references to API manufacture within this legal document refer to the requirement for API GMP and quotes the GMP directive (2003/94/EC) for guidance.  The FMD does not update 2003/94/EC therefore the UK law does not incorporate the requirements of the FMD.  As a QP in the UK one of your legal duties states; ‘….each batch has been manufactured in accordance with these regulations…..’ (ie SI 2012/1916) not 2001/83/EC.   

A draft amendment to SI 2012/1916 is available on the MHRA website which does incorporate the requirement for the written confirmation (Chapter 4, Paragraph 45P) as well as the other requirements under FMD (e.g. GDP for API).  As of today (2^nd July) this draft has not been incorporated into UK law.

Summary

The written confirmation deadline for APIs has come and gone.  As we currently stand the UK law does not match the requirement within the falsified medicines directive with regards to the written confirmations of imported APIs.   

During this intervening time while we await an update to SI 2012/1916 what should the UK QPs be doing - following FMD or UK Law?  It might make for a good scenario question................