Last week’s round -up;
15-19 March 2021
The EMA is collaborating with the UK as per the EU-UK Trade and Cooperation Agreement (Annex TBT2 – Medicinal Products). Under the agreement, the EU and UK recognise the outcomes of GMP inspections carried out by the other party in their territories and may also recognise the outcomes of inspections carried out in other third countries. The products covered by the agreement include marketed medicinal products for human or veterinary use, including marketed biological and immunological products for human and veterinary use, advanced therapy medicinal products, active pharmaceutical ingredients for human or veterinary use and investigational medicinal products.
CEP holders – Avoiding the rejection of notifications
The EDQM Guideline on requirements for revision/renewal of Certificates of Suitability to the European Pharmacopoeia Monographs (PA/PH/CEP (04) 2, 7R corr) lists different notifications and associated conditions for CEP revisions and renewals. Any change that is not classified as a notification or a major change should be classified as a minor change by default (except for editorial changes which are covered by specific guidance in the policy document) to avoid rejection. For revised discussions on impurities in section 3.2.S.3.2, and the submission of nitrosamine risk assessments, minor revisions should be submitted. Changes to the synthesis or to the control strategy that are introduced to reduce or eliminate the risk for the formation of nitrosamine impurities or other mutagenic impurities, should be classified according to the EDQM guideline (i.e. minor, major revision or sister file application).