News

Last week’s round -up;
25-29 January 2021

published 1 Feb 2021

UK MHRA makes off-label prescribing updates to UK COVID-19 vaccines

The UK MHRA has updated the information for healthcare professionals and the public for the three COVID-19 vaccines authorised for use to date in the UK, with new versions of the Conditions of Authorisation documents containing an additional clause relating to off-label prescribing.

Links to the three sets of approval documentation are given below:

AstraZeneca COVID-19 Vaccine: http://bit.ly/3iWSjbU

Pfizer/BioNTech COVID-19 Vaccine: http://bit.ly/3pvc4dl

Moderna COVID-19 Vaccine: http://bit.ly/3puPfq9

Analytical method for nitrosamines in cosmetics

The EDQM has published an analytical method for the determination of polar N-nitrosamines in cosmetic products. This new method has been validated within the European Network of Official Cosmetics Control Laboratories (OCCLs). The analytical method uses liquid chromatography coupled to mass spectrometry and is suitable for the determination of several polar N-nitrosamines that may be found in cosmetics and tattoo inks, in the concentration range 10-1,000 µg/kg.

A detailed description of the method is available for free on the EDQM Freepub website: http://bit.ly/RealCMC-3iYceYf

MHRA Guidance on ASMFs and CEPs

The MHRA is continuing to accept Active Substance Master Files (ASMFs) and Certificates of Suitability (CEPs) in both new national initial MAAs and in variation applications. ASMFs should be prepared in accordance with CHMP guideline on active substance master file procedure (CHMP/QWP/227/02 Rev 4) and any changes to an ASMF should also be tackled in accordance with this guideline. The ASMF holder should make such applications using the MHRA submissions portal. There have been no changes to the procedures related to CEPs since these are issued by the EDQM, which is a Directorate of the Council of Europe, a body that is independent of the EU. The UK is still a member of the Council of Europe and a signatory to the Convention on the Elaboration of a European Pharmacopoeia.

Further information may be found here: http://bit.ly/RealCMC-3pgMybn