medicines-medical devices-regulatory affairs
Issue 76 (February 2024) of the HPRA Medicinal Products Newsletter has been published. As usual, it is packed with information and includes (but is not restricted to) the following information: 1) Clinical trials applications – Important dates and information Applicants…
Last updated: 16 June 2023 See updates at the end of the post. The UK MHRA has published guidance on 150-day assessment for national applications for medicines from 1 January 2021. The 150-day assessment for national applications The MHRA offers…
Following a consultation in 2020, the UK MHRA has published detailed guidance on the licensing of biosimilar products. Who is the guidance for? The purpose of the guidance is to provide developers of similar biological medicinal products (aka biosimilars) with…
The MHRA has updated its guidance on applying for a variation to your marketing authorisation. The original guidance was published in December 2014. Following the end of the transition period on 31 December 2020, the guidance has been updated with…
The UK MHRA has updated is guidance on variations to Marketing Authorisations (MAs) from 1 January 2021. The original guidance was published on 27 October 2020. In the latest update, further information is provided on variations for products that were…