New EU GDP Guidelines coming for 2028?
- Mar 23
- 2 min read
What is new in the new EU pharma package for EU Wholesalers?
Relevant extracts from the draft EU Directive that impact wholesalers are set out below. There are additions that will impact the current GDP Guidelines and I will require a revision to 2013/343/01.
I consider the impact on wholesalers in the UK after each Article. In summary the new parts impacting wholesales are:
A new requirement for wholesalers to specifically record and report ADRs to the MAH. This has typically been understood to be a requirement captured under the existing Complaints recording requirements in GDP chapter 6. If this is added to EU GDP, for UK wholesalers this should require only an SOP review and update.
EU specific need to have an established address in the EU. Change of wording to say responsible person rather than that in current Directive. Now aligned to wording in UK Human Medicines Regulations
One for MHRA to consider in their approach to granting new WDA(H)s. MHRA is still aligned to the EU approach to inspections as set out in HMR reg 331A The Human Medicines Regulations 2012
The EU will seemingly restrict EU wholesalers from buying medicines outside of the EU. This means any EU wholesalers purchasing stock fiscally from third countries will have to stop. This means no EU wholesaler can buy from the UK and the ‘introduced medicines’ trade where companies buy from the UK and sell to another non EU country will cease.
It is hard to imagine that MHRA will want to copy this part of the new Directive restricting GB wholesalers to only deal with UK wholesalers.
Introduces requirements for wholesalers to assist in managing and reporting shortages. Some specifically EU related obligations that elements of which could be copied into UK law
A EU specific requirement when selling medicines in the EU..
The potential to stop the need for a paper document being sent with each delivery. This aligns with the MHRA proposal to do similar so likely to be adopted by the UK.
The EU exemption that allows EU wholesalers to export to third countries – i.e. the UK.
Confirmation that a new GDP to be prepared in the EU to include managing ATMPs by the EU Commission
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