The EMA has published the minutes from the CVMP's October meeting, which includes two new referrals for VMPs containing paromomycin and tylosin. Guidance documents adopted in the September meeting have also now been made available, covering antimicrobials, resistance in ectoparasiticides and withdrawal periods. In addition, there have been updates on the electronic application form (eAF) and the SPOR data services.
The EMA has posted the press release with details of the CVMP's meeting of 9 – 11 October 2018 (Link). General news relating to regulatory affairs includes:
An Article 35 procedure (community interest) was referred by Belgium, relating to concerns over the indications, posology and withdrawal periods for VMPs containing paromomycin for parenteral administration to pigs.
A second Article 35 procedure was referred by the Netherlands, relating to concerns over the withdrawal periods of VMPs containing tylosin for solution for injection in sheep.
The consultation period for the draft guideline on the manufacture of veterinary finished dosage form has been extended to August 2019.
The adopted documents will be published on the EMA website in the coming weeks.
The EMA has now published the following documents adopted in the September meeting of the CVMP:
Draft Reflection paper on resistance in ectoparasites (Link).
Following a brief transition period, the new version of the electronic application forms (eAF v126.96.36.199) is now in effect and updated user guidance has been published (Link).
Relating to the SPOR project's Referentials Management Service (RMS) and Organisations Management Services (OMS), the EMA has publshed information regarding the on-boarding of users to SPOR data services, which it is highlighted relate to both medicines for human use and veterinary use (Link).