EMA: Work on Annex 1 and Annex 21 will continue

The European Medicines Agency (EMA) has to face challenges like the relocation to Amsterdam and the loss of personnel. Because of this, EMA needs to temporarily scale back or suspend additional activities. EMA has now published a press release and announced the next phase of its Brexit preparedness business continuity plan (BCP), which entered into its third phase. The BCP will help to define core activities related to the evaluation and supervision of medicines.

"EMA will now temporarily suspend or scale back additional activities to ensure that resources can be redeployed so that its core activities can continue without interruption and to the same quality," commented Noël Wathion, EMA's Deputy Executive Director. "Over the next few months, EMA will continue to carefully monitor staff intentions to relocate and the anticipated impact on its activities whilst planning for the critical time period when the Agency will be moving to its new premises in Amsterdam."

Despite the necessary temporary suspension/ scaling back of activities, EMA has defined seven guidelines, which will exceptionally continue during BCP phase 3:

  • 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.
  • Good Pharmacovigilance Practice: Pregnancy and Breast Feeding.
  • Revision 6 of Note for Guidance on the evaluation of anticancer medicinal products in man.
  • Guideline on the use of minimal residual disease as a clinical endpoint in Multiple Myeloma trials.

Furthermore, meetings of product-related working parties will continue as scheduled; but all meetings of non-product related working parties have been temporarily put on hold.

EMA to Industry Stakeholder Meeting on Brexit

On 24 September 2018, an EMA to Industry Stakeholder meeting on Brexit and operation of the centralised procedure for human and veterinary medicinal products took place in London. The aim was to update each other on the status of the respective preparedness activities, followed by a longer Brexit Q&A session. The presentations of the meeting have now been published on the EMA website. A high level report of the meeting will be published in due course.

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