CRED Getting the CMC Dossier Right 2024

29/08/2024

Drug substances & Brexit

⚫ Exporting active substances manufactured in Great Britain for use in EEA and Northern Ireland from 1 January 2021

● https://www.gov.uk/government/publications/exporting-active-substances-manufactured-in-great-britain-for-use-in eea-and-northern-ireland-from-1-january-2021

● how to obtain a Written Confirmation for each shipment of Active Substances manufactured in the UK that is exported to the EEA and Northern Ireland

● Since 1 January 2021 we continue to accept importation of active substances into Great Britain (England, Wales and Scotland) without a Written Confirmation from the same list of countries as currently (European Economic Area (EEA) countries, USA, Japan, Republic of Korea, Brazil, Australia, Israel and Switzerland) as well as from Northern Ireland . ● Northern Ireland also continues to align with all relevant EU rules relating to the placing on the market of manufactured goods.

The Organisation for Professionals in Regulatory Affairs

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Drug substances & Brexit

⚫ Handling of Active Substance Master Files and Certificates of Suitability from 1 January 2021

https://www.gov.uk/guidance/handling-of-active-substance-master-files-and-certificates-of-suitability-from-1-january 2021

• MHRA continues to accept an Active Substance Master File and/or a Certificate of Suitability in both new national initial and variation applications

• ASMFs:

• The UK no longer participate in ASMF worksharing procedures with EU Member States.

• The CHMP guideline on active substance master file procedure (CHMP/QWP/227/02 Rev 4) remains applicable.

• CEPs:

• CEPs are not affected by the UK leaving the EU as they are issued by EDQM and the UK will remain a member of the Council of Europe.

⚫ All guidance for end of transition period: https://www.gov.uk/government/collections/mhra post-transition-period-information; HMR: https://www.legislation.gov.uk/uksi/2019/62/made

The Organisation for Professionals in Regulatory Affairs

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