CVMP guidance adopted in February now available online

The guidance documents adopted by the CVMP in their February meeting have now been published on the EMA website:

• In response to the EC’s request for updated advice regarding the use of colistin in animals, the Committee agreed a timetable for the update (Link)
• The Committee adopted a revised draft guideline for consultation, on the conduct of efficacy studies for intramammary products for use in cattle (Link)
• The Committee adopted a new reflection paper for consultation, on the authorisation of VMPs containing (potential) Persistent Bioaccumulative and Toxic (PBT) or very Persistent and very Bioaccumulative (vPvB) substances (Link)
• The Committee adopted Questions and Answers (Q&A) on the SPC guideline for antimicrobials, in regard to suitable pack sizes for antimicrobials (Link)
• The Committee adopted two revised VICH guidelines for consultation:
  • VICH GL50: Revised guideline on Harmonisation of criteria to waive target animal batch safety testing for inactivated vaccines for veterinary use (Link)
  • VICH GL55: Revised guideline on Harmonisation of criteria to waive target animal batch safety testing for live vaccines for veterinary use (Link)

Additional guidance documents agreed during the meeting will be published in due course.