Pharma sector wants changes to EU good distribution practice reforms
Bristol-Myers Squibb and EFPIA voice concerns
Pharmaceutical major Bristol-Myers Squibb is among 85 mainly health-centred organisations requesting changes to the latest European Commission planned reforms to European Union (EU) pharmaceutical good distribution practice guidance.
Commenting on proposals that medicinal products not intended for EU markets should be kept in segregated areas, B-MS said: ‘For supply chain efficiency, many companies ship their goods together. For example, products for Norway, Iceland, Switzerland and Russia, are stored with EU [products].’ As cargoes are only split upon dispatch ‘it will be very difficult to apply this requirement’, said the company.
B-MS added that EU drafts saying medicines should remain just 24 hours in transportation hubs before onward deliveries were also incorrect, as cargoes could be held for a week.
Meanwhile, the European Federation of Pharmaceutical Industries and Associations (EFPIA) called on the EU to pay heed to international guidance (such as that from the World Health Organisation) when drafting European advice, because of ‘the global environment that we now operate in’.
The European Federation also called for more clarity on guidance for shipping temperatures; highlighted a failure to address repackaging and relabelling; and a need for more consistency regarding companies considered as ‘distributors’ or ‘wholesale distributors’, an issue that sparked potential confusion.