This guidance provides information on the format and content of paediatric applications in the United Kingdom (UK) from 1 January…
Legal requirements for UK-PIPs are set out in the Human Medicines Regulations 2012.
This guidance sets out how the MHRA, acting for Great Britain, will handle centralised applications that are still pending on 1…
The UK will require the sponsor or legal representative of a clinical trial to be in the UK or country listed on an approved…
From 1 January 2021, the following legal obligations will apply to UK marketing authorisations (MAs).
How traditional herbal medicines and homoeopathic medicines will be treated by the MHRA from 1 January 2021.…
The way you apply to licence biological products will change from 1 January 2021.
From 1 January 2021 the MHRA is introducing changes to national licensing procedures.
The MHRA will retain responsibility for pharmacovigilance across the UK from 1 January 2021.
Goods placed on the market in the European Union or the United Kingdom before the end of the transition period may continue to circulate between…