For pretty much the whole of the last six months the team at PCL have been trying to make headway with certain issues thrown up by the EU Guidelines on GDP for Medicinal Products for Human Use (5th Nov 2013).
On face value it is hugely helpful that there are common guidelines across the EU, in theory it creates a level playing field and should ensure the proper handling of medicines across the EU markets. However the enforcement and more particularly local interpretation of ‘the guidelines’ varies across the member states.
I fully support the MHRA in their very literal interpretation and broadly consistent assessment during inspections; however the real problems are experienced by businesses dealing with other member states, particularly those in sectors like the marine safety industry.
The UK authorities again have made clear statements about their expectations on UK suppliers however their obligations to Qualify Customers can prove virtually impossible in some countries whose authorities seem unwilling or unable to give practical guidance.
Surely with something as important as maritime safety it can’t be beyond the wit of man for the EU to ensure there is clear policy based on practical realities within each country and that those policies are available to other member states.