Last week’s round -up;
07-11 December 2020

published 15 Dec 2020

Brexit – Article 41 of the Withdrawal Agreement

The EC and EMA have published a notice to stakeholders titled ‘Withdrawal of the United Kingdom and EU Rules for Medicinal Products for Human Use and Veterinary Medicinal Products’ (Rev 3, dated 13 March 2020). Article 41 of this agreement indicates that medicines, which are certified by a Qualified Person and have been released in the United Kingdom for sale or supply before 11 pm on 31 December, can be supplied to the Irish market after the transition period ends. The receiving site in Ireland must ensure that certain requirements, described in the following article, are met:

New Ph. Eur. general chapter for the analysis of N-nitrosamine impurities

The Ph. Eur. Commission has adopted a new general chapter on the analysis of N-nitrosamine impurities in active substances (2.5.42). The general chapter covers the different needs of control laboratories as it proposes three procedures which rely on different instruments (GC-MS, LC-MS/MS and GC-MS/MS). The chapter focuses mainly on the analysis of N-nitrosamine impurities in angiotensin-II-receptor antagonists (sartans) containing a tetrazole group, including valsartan, losartan potassium, candesartan cilexetil, irbesartan and olmesartan medoxomil. However, the procedures may also be applied to other substances or to medicinal products following demonstration of suitability for the intended purpose with additional validation.

Joint published EMA and HMA strategy sets direction for EMA and EU medicines regulatory agencies to 2025

The European Medicines agency and Heads of Medicines Agencies, have published their joint strategy for the next 5 years. It lists 6 areas of priority, availability and accessibility of medicines; data analytics, digital tools and digital transformation; innovation; antimicrobial resistance and other emerging health threats; supply chain challenges; and finally the sustainability of the network and operational excellence. Emer Cooke, EMA’s Executive Director commented that “The COVID-19 pandemic has highlighted the pivotal role of medicine regulation for the protection of public health,” and “This strategy ensures that we join forces across the EU to effect tangible improvements for citizens.”

Full details of the news item and a link to the strategy document can be found here:

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