The EMA has posted the press release with details of the CVMP's meeting of 15 - 17 March 2016 (Link). General news relating to regulatory affairs includes:
- The Committee noted the revised note for guidance on limitations to the use of ethylene oxide in the manufacture of medicinal products. This note for guidance is now applicable to VMPs only (Link to Word document).
- The Committee adopted a reflection paper on poorly extractable and/or non-radiolabelled substances following the close of the public consultation (Link). The overview of comments has also been published (Link).
- The Committee adopted a Questions and Answer document: Mixtures of active pharmaceutical ingredients with one or more excipients. This will be published on the EMA website in due course.
- It will become mandatory to make submissions via the Gateway / Web Client mandatory for all documentation related to veterinary centralised procedures from 1st January 2017. A new pilot of the Gateway system will be released on 23rd May 2016.
