Marketing authorization holders have three years from 17 May 2023 to remove any “negative formulations” from their existing and future medicines packaging.
In September 2022, the Borderline and Classification Working Group, a subgroup of the Medical Device Coordination Group (MDCG), issued a manual to determine whether a particular product qualifies as a medical device or in vitro diagnostic and into which class a particular medical device or in vitro diagnostic falls. The MDCG is operating under the Medical Device Regulation and the In Vitro Diagnostic Medical Device Regulation.
Baker McKenzie’s Sanctions Blog published the alert titled Ukraine: The law on cancelling marketing authorizations due to ties with Russian/Belarusian pharmaceutical manufacturing became applicable on 24 August 2022. Read the article via the link here. Please also visit our Sanctions Blog for the most recent updates.
Baker McKenzie’s Sanctions Blog published the alert titled Ukraine: the law on canceling marketing authorizations due to ties with Russian/Belarusian pharmaceutical manufacturing became effective on 20 June 2022. Read the article via the link here. Please also visit our Sanctions Blog for the most recent updates.
Baker McKenzie’s Sanctions Blog published the alert titled Ukraine: Cancellation of marketing authorizations for pharmaceuticals manufactured in Russia or Belarus or held by companies affiliated or otherwise related to those with manufacturing facilities in Russia or Belarus on 25 May 2022. Read the article via the link here. Please also visit our Sanctions Blog for the most recent updates.
Baker McKenzie’s Sanctions Blog published the alert titled Ukraine may cancel marketing authorizations for pharmaceuticals held by companies with ties to pharmaceutical manufacturing in Russia or Belarus on 9 May 2022. Read the article via the link here. Please also visit our Sanctions Blog for the most recent updates.
The new Clinical Trials Regulation became applicable on 31 January 2022, following achievement of the full functionality by the new Clinical Trials Information System, bringing more transparency into the area of clinical trials.