By Ministerial Decision No. 73890/17.10.2025 (Government Gazette B’ 5566), titled “Determination of the procedure for granting the Supplementary Protection Certificate for medicinal products – Repeal of Joint Ministerial Decision No. 14905/EFA/3058/30.12.1997”, which governs the procedure for granting Supplementary Protection Certificates for medicinal products, the process for granting SPCs is improved, among other things, through a more comprehensive examination of the conditions for granting such certificates.
Under this Ministerial Decision:
- Joint Ministerial Decision No. 14905/EFA/3058/30.12.1997—which had regulated the SPC granting procedure until now—is expressly repealed.
- Paragraph 1 of Article 7 of the repealed decision is amended so that, from now on, the Hellenic Industrial Property Organisation (OBI) shall conduct a full examination of all the conditions set out in Article 3 of Regulation (EC) No 469/2009 of the European Parliament and of the Council, explicitly including points (c) and (d), which relate to the validity of the first marketing authorization and the absence of a previously issued certificate for the same product.
Furthermore, it is established that applications for the granting of Supplementary Protection Certificates submitted from 1 September 2025 onwards shall be examined exclusively under the provisions of the new Ministerial Decision, in accordance with the updated procedural and substantive requirements it lays down.
Β 5566_Ministerial Decision 73890_17.10.2025_SPC for Medicines (Greek)
