EMA updates from Sep/Oct include new referrals and guidance for antimicrobials, ectoparasiticides and withdrawal periods

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. 

CVMP October meeting minutes

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:

Community referrals for paromomycin and tylosin

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.

Guidance for Chemistry, Manufacturing and Controls (CMC)

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.

Guidance adopted in the CVMP September meeting

The EMA has now published the following documents adopted in the September meeting of the CVMP:

Ectoparasiticides

Draft Reflection paper on resistance in ectoparasites (Link).

SPC for antimicrobials and development of resistance

• Draft guideline on the summary of product characteristics (SPC) for veterinary medicinal products containing antimicrobial substances - Revision 1 (Link).
• Draft Reflection paper on the use of aminopenicillins and their beta-lactamase inhibitor combinations in animals in the European Union: development of resistance and impact on human and animal health (Link).

Consumer safety

Guideline on determination of withdrawal periods for edible tissues (Link), together with overview of comments (Link).

Electronic submissions and data management

Following a brief transition period, the new version of the electronic application forms (eAF v1.23.1.0) 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).