The EMA has posted the press release with details of the CVMP's meeting of 17 – 19 January (Link). General news relating to regulatory affairs includes:
- Four MAH’s requested re-examination of the CVMP opinion on the Article 35 referral for VMPs containing zinc oxide to be administered orally to food producing species. The procedure will be initiated once the MAHs’ detailed grounds for the re-examination are submitted.
- A concept paper on the need for revision of the note for guidance on quality of water for pharmaceutical use was adopted for public consultation (not available at time of publication).
- A correction to the reflection paper on the requirements for selection and justification of starting materials for the manufacture of chemical active substances was adopted (not available at time of publication).
- A revised guideline on the conduct of efficacy studies for intramammary products for use in cattle was adopted following a second public consultation (Link). The overview of comments (from IFAH-Europe and AVC) has also been published (Link).
A summary of all decisions made by CVMP in 2016 (and in previous years), including all positive opinions for new VMPs and establishment of MRLs can be found in the latest EMA monthly report (Link) and in the EMA’s 2016 highlights publication (Link).