WebAn SPC can extend a patent right for a maximum of five years. A six-month additional extension is available in accordance with Regulation (EC) No 1901/2006 if the SPC relates … Web5 Apr 2024 · The draft regulation also reminds us, and rightly so, about the need to protect the rights of SEP owners under Article 17(2) of the EU Charter of Fundamental Rights, which notoriously includes IP. But it includes a restriction on the ability to enforce a SEP that has not been registered within a certain time-limit and introduces a requirement to conduct a …
Regulatory approval of Pfizer/BioNTech vaccine for COVID-19
Web19 Dec 2024 · SPCs. Summaries of Product Characteristics (SPCs) is a description of a medicinal product’s properties and the conditions attached to its use. It explains how to … Web2.2 The changes to the SPC system are needed to take account of changes to the regulation of medicines and agrochemicals when the Northern Ireland Protocol comes into effect. This will see the introduction of new marketing authorisations that will be valid for only part of the territory of the UK. A marketing authorisation is required for nova dentist east finchley
MHRA Products Home
Web1 Nov 2011 · Legislative framework. SPCs for medicinal products were created by: Regulation (EEC) 1768/92 concerning the creation of a supplementary protection certificate for medicinal products (Medicinal Products SPC Regulation), which came into force on 2 January 1993. Regulation (EC) 469/2009 concerning the supplementary protection … WebA regulation is therefore the most appropriate legal instrument. (9) The duration of the protection granted by the certificate should be such as to provide adequate effective protection. Web12 Oct 2024 · Just over 2 years after the SPC waiver Regulation (EU) 2024/933 (amending the Regulation (EC) No 469/2009) entered into force (1 July 2024), and only a few months after the end of the transitional provisions for application of the SPC waiver under Art. 5(10) of the Regulation (2 July 2024), I have decided to follow up on my previous post on the … nova dentists north haven