I have written before about the implications upon RPs from the current EU consultation exercise on GDP.
There are other implications of the consultation, if it is implemented, concerning for example the Quality Systems operated by Wholesale dealers. At present in the UK, a wholesale dealer is not required to operate a quality system as such, although the sum total of written standard operating procedures already required by the MHRA should mean that UK wholesale dealers are operating their business in a way that does put some emphasis on quality management principles.
Although the EU consultation does recognise that the “size and complexity of a distributor’s activities should be taken into consideration when developing a quality management system or modifying an existing one” it is clear that if the consultation is implemented, all distributors will have to develop a Quality System, including a quality manual.
This will present quite a lot of work for the vast majority of smaller distributors who do not presently operate a quality system as such, nor have a quality manual. The consultation also requires that any activities that distributors choose to outsource, such as perhaps warehousing and distribution, must also be covered by the quality system.
Whilst in principle, it is hard to argue against any sensible initiative that improves patient safety, no evidence is offered in or with the consultation to suggest that companies already operating such systems are in fact safer than those operating without them. Also there is no recognition of the significant costs that could be involved for the majority of distributors who would have to implement a quality system for the first time.
At the very least, I believe that the EU should grant distributors until 1/1/2013 to give sufficient time to comply with this requirement on quality systems for all medicines distributors.