IPPT20110728
Supplementary Protection Certificate (‘SPC’) only available for medicinal products with a market authorisation under Directive 65/65 having undergone safety and efficacy tests
• that a product, such as that at issue in the main proceedings, which was placed on the market in the Community as a medicinal product for human use before obtaining a marketing authorisation in ac-cordance with Directive 65/65, and, in particular, without undergoing safety and efficacy testing, is not within the scope of Regulation No 1768/92, as defined in Article 2 of that regulation, and may not be the subject of an SPC.
IPPT20110728, CJEU, Synthon v Merz
