HvJ EU: Is einde van erkenningsprocedure onder 28 lid 4 Geneesmiddelenverordening hetzelfde als handelscertificaat
Prejudiciële vraag gesteld aan HvJ EU 29 juli 2016, IEF 16169; IEFbe 1893; RB 2746; LS&R 1354 (MSD tegen Comptroller-General)
ABC. Octrooi. Erkenning handelsvergunning .
(1) Is an end of procedure notice issued by the reference member state under Article 28(4) of the Medicinal Products Directive equivalent to a granted marketing authorisation for the purposes of Article 3(b) of the SPC Regulation?
(2) If the answer to question (1) is no, is the absence of a granted marketing authorisation at the date of the application for a certificate an irregularity which can be cured under Article 10(3) of the SPC Regulation once the marketing authorisation has been granted?