The EU commission have just published for consultation new Guidelines on Good Distribution Practice (GDP) for human medicinal products.
Ostensibly the reasons given for the consultation and proposed guidance updating are that the previous EU GDP guidance is 17 years old and also that the EU felt a need to include more guidance on Counterfeit medicines awareness and detection, individually quite valid points. The new guidance included on Counterfeit detection is however in my view unimpressive, and insufficient to lead to any real improvements in detection rates.
However, lurking within the 32 page consultation document are a whole raft of other changes, minor and some more significant, quite a few of which will affect all wholesale distributors of medicines across the EU and all RPs (Responsible Persons).
For example, in the section of the consultation document on Personnel, there are 12 specific responsibilities listed for RPs, some of which are either new or significant developments of existing guidance. One particular proposal (2.1) says that an “RP should fulfil his/her responsibilities personally and should be permanently available”. whilst there is no clarification as to what “permanently available” is meant to mean, could this be a planned move against Contract RPs? It is to be hoped not, as a similar MHRA consultation in recent years suggested that the UK Wholesale distribution market could not continue without Contract RPs, as there were simply not enough RPs around for each Distributor to employ one as an employee. Also smaller or specialist distributors simply could not justify the cost of an employed RP.
The consultation document whilst not exactly a riveting read, contains much food for thought for Wholesale medicines distributors across the EU, and I would recommend that all RPs should sit down with their clients in the near future and go through the consultation document together and develop a plan of action as to how to comply from early 2012.
The deadline for replying to the consultation submissions is 31st December 2011.