medicines-medical devices-regulatory affairs
This post is an attempt to provide basic information about patents, Supplementary Protections Certificates (SPCs) and Supplementary Protection Certificate (SPC) manufacturing waivers. The information provided is by no means exhaustive. About patents In all countries that are members of the…
Last updated: 18 March 2024 See updates at the end of the post. On 27 April 2023, the Commission proposed new rules to help companies, especially small and medium-sized companies (SMEs), make the most of their inventions, leverage new technologies…
This post concerns a recent court case in which an EU Supplementary Protection Certificate manufacturing waiver was put to the test in a Munich court. About Supplementary Protection Certificate (SPC) manufacturing waivers With the entry into force of Regulation (EU) 2019/933 on…
Last updated: 9 July 2024 See updates at the end of the post. On 1 July 2022, the transitional period for the application of the Supplementary Protection Certificate (SPC) manufacturing waiver ended. The SPC manufacturing waiver became operational from 2…