For all procedures if necessary - SPC, labels and leaflet: Prior to the authorisation, proposed texts of the SPC, labels and leaflet in portuguese (and english if necessary) and proposed mock-ups in portuguese, should be sent in electronic format.
Proof of payment must quote the Decreto-Lei n.º148/2008, of july29, alterado pelo Decreto-Lei n.º314/2009, of october 28, the name of the veterinary medicinal product, the type of application (MA, Type I variation… etc.) and, in case of MRP/DCP, the MRP/DCP application number.
