EAPHM Newsletter January 2018
The European Medicines Agency has released for public consultation a draft concept paper for the revision of the guideline on the summary of product characteristics for veterinary anthelmintics.
The current guideline on the Summary of Product Characteristics (SPC) for anthelmintics (EMEA/CVMP/EWP/170208/2005) recommends standard warnings aimed at delaying the development of anthelmintic resistance. The scope of the guideline is currently limited to products for sheep, goats, cattle and horses, and proposes standard text for sections 4.4 and 4.9 of the SPC. This concept paper proposes that the scope of the guideline be extended to host species other than ruminants and horses, e.g. to pigs and companion animals. Read the concept here.
