Brussels releases guidance for improving pharmaceutical logistics
How to establish quality systems and sets out responsibilities, processes and risk management
The European Commission (EC) has released advice to pharmaceutical wholesalers and distributors on how to increase their efficiency and help them prevent the trade in illicit and counterfeit medicinal products.
‘Today’s distribution network for medicinal products is increasingly complex and involves many players,’ the European Union (EU) executive said. ‘The revised guidelines lay down appropriate tools to assist wholesale distributors in conducting their activities and to prevent falsified medicines from entering the legal supply chain.’
The advice breaks new ground outlining how to establish quality systems and sets out responsibilities, processes and risk management regarding pharma wholesale services. It states what documentation is required, preventing errors more prevalent within spoken communications.
The guidance also lays down standards saying that sufficient competent personnel must be employed, able to ‘carry out all the tasks for which the wholesale distributor is responsible’.
There must be an appropriate management of complaints, returns, suspected falsified medicinal products and recalls
In addition, adequate premises, installations and equipment must be in place to ensure proper storage and distribution of medicines. There must be an appropriate management of complaints, returns, suspected falsified medicinal products and recalls. Wholesalers and distributors must organise their outsourced activities in a sufficiently logical way to avoid misunderstandings and confusion within their organisations.
The guidance includes rules for transportation to protect medicines against breakage, adulteration and theft, while ensuring cargoes are kept at correct temperatures. And there must be clear and specific rules in place defining the role of brokers selling or purchasing pharmaceuticals.
‘It is of key importance that the quality and the integrity of the medicinal products are maintained during the entire supply chain from the manufacturer to the patient,‘ said the EC.
Most of the guidelines will come into force on 8 September, except for an obligation for wholesalers and distributors to record product batch numbers, which will be required, probably, from 2017 – three years after the EC agrees a relevant rule, which officials anticipate will happen next year (2014).