medicines-medical devices-medtech-regulatory affairs
medicines-medical devices-medtech-regulatory affairs
Last updated: 29 June 2022 Report from the CMDh meeting held on 21-22 June 2022 The following items are included in the report from the above meeting: i) Request form for MRP/RUP for Medicinal Products for HumanUse The CMDh has…
Last updated: 31 May 2022 Nitrosamine risk evaluations 1) The following two updated documents can be downloaded from this page: i) NEW – Template for nitrosamine risk evaluation in marketing authorisation applications ii) UPDATE – Step 2 – Nitrosamine detected response…
Last updated: 29 March 2022 Report from the CMDh meeting held on 22-23 February 2022 Included in the report and minutes from the above meeting are the following items: CMDh position on PASS results according to Art. 107q of Directive 2001/83/EC concerning…
Information update on Periodic Safety Update Reports (PSURs) Updated information has been provided on a number of points concerning PSURs. The inforation answers a ragne of questions including the following: Should EU HBDs also be used for PSURs for generic…
Last updated on 18 March 2022 See updates at the end of the post Q & A for marketing authorisation holders/applicants on the CHMP Opinion for the Article 5(3) of Regulation (EC) No 726/2004 referral on nitrosamine impurities in human…
Report from the CMDh meeting held on 14-16 December 2021 The report from the above meeting has now been published. Included in the report are the following items: Implementation of outcome of Art. 31 referral on angiotensin-II-receptor antagonists (sartans) containing…
CMDh meeting 9 – 11 November report The report from the above meeting is available here. Items of note include the following: 1) Risk of azido-impurity in losartan-containing medicinal products In September 2021 the CMDh published a letter addressed to…
This post will be updated on an ad hoc basis. Report from the CMDh meeting held on 12-13 October 2021 Some items of note in this report include the following: CMDh Best Practice Guide on Multilingual Packaging The CMDh has…
Report from the CMDh meeting held on 14-16 September 2021 The report from the above meeting can be viewed here. It includes the following information: Reminder to MAHs for products containing chlorobutanol as an excipient at a level above the…
CMDh Minutes for the meeting on 22-23 June 2021 The minutes for the above meeting are now available here (24 page document) and the following items are included: 1. Brexit (pg 7) The CMDh discussed a topic included under 8.3…