News about GMP/cGMP


EMA: Brexit Preparedness Plan Phase 3

The parallel preparing of the UK’s exit from the EU, the physical move to Amsterdam and operating “business as usual” as long as possible is the declared aim of the EMA. As of October 2018, EMA has launched Phase 3 of the “Brexit Prepardness Plan”, which results in additional temporary suspensions and scaling back of activities.

One of the temporary reductions includes guideline development which will be further reduced until 30 June 2019. As outlined in the Phase 3 Plan work will be continued without scale back on the following GMP relevant documents:

  • Revision of Annex 1 of the EU GMP Guide (H/V) – Manufacture of sterile medicinal products
  • New Annex 21 of the EU GMP Guide (H/V) – Guidance for importers of medicinal products
  • Reflection Paper of Good Manufacturing Practice and Marketing Authorisation Holders
  • Guideline on quality requirements of medicinal products containing a device component for delivery or use of the medicinal product
  • ICH Q12: Pharmaceutical Product Lifecycle Management.


EMA: Prepardeness Plan Third Phase