At the end of the transition period, the UK will have in place arrangements for the continued authorisation of medicinal products.
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- November 30, 2020
- November 30, 2020
Batch testing (quality control testing) of human medicines will be accepted from the following countries.…
November 30, 2020From 1 January 2021 reference medicinal products will have to fall within the definition in regulation 48 of the Human Medicines…
November 30, 2020This guidance addresses the common scenarios that may occur when a UK paediatric procedure is submitted to the Medicines and…
November 30, 2020The Human Medicines (Amendment etc.) (EU Exit) Regulations 2019 inserted these requirements into the Clinical Trials regulations.…
November 30, 2020The requirements and procedures for clinical trials in the UK are set out in the Medicines for Human Use (Clinical Trials)…
November 30, 2020The MHRA will offer incentives in the form of market exclusivity and full or partial refunds for marketing authorisation fees to…
November 30, 2020Outcomes of inspections conducted by the UK competent authority before the end of the transition period - It is expected that findings of inspections…
November 30, 2020Article 33(1) of Commission Delegated Regulation (EU) 2016/161 requires marketing authorisation holders to ensure that unique identifiers and related…
November 30, 2020Any local representative located in the United Kingdom and nominated for Member States other than the United Kingdom will have to be changed to a…
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