date: 13/05/2019
The FAMHP points out to marketing authorisation (MA) holders and applicants the rules for harmonisation of SPC’s, labelling and patient information leaflets (PIL) in different countries. MA holders and applicants can find all new rules on the FAMHP website.
During the national phase of closure of a marketing authorisation procedure, its renewal or variation (with changes made to the SPC, PIL or labelling) of a medicine for veterinary use, translations of the texts in French and Dutch of the SPC, and texts in French, Dutch and German of the labelling and PIL must be submitted. All rules for harmonisation of SPCs, labelling and PILs in different countries can be found on the FAMHP website.