3/11付・3/12付に続いて、3/18付で英国MHRAからBrexit No-deal（合意なき離脱）に伴う更新通知が多数発出されています。
Brexit自体の延期の可能性も踏まえてか、以前にお伝えした案件に加えて多数の案件が通知されています。
興味のある方は、下記URLs（更新については前回と同じ）のウェブサイト並びにサイト内のリンク先をご参照ください。
［全体のウェブサイト］
l更新「MHRA guidance and publications on a possible no deal scenario」
https://www.gov.uk/government/collections/mhra-guidance-and-publications-on-a-possible-no-deal-scenario
［今回の更新および追加］
l更新「Exporting active substance manufacturer in the UK if we leave the EU without a deal」
https://www.gov.uk/government/publications/exporting-active-substance-manufacturer-in-the-uk-if-we-leave-the-eu-without-a-deal
l「Licensing of biological products: biosimilars, ATMPs and PMFs in a no deal scenario」
https://www.gov.uk/guidance/licensing-of-biological-products-biosimilars-atmps-and-pmfs-in-a-no-deal-scenario
l「Guidance on new provisions for traditional herbal medicinal products and homoeopathic medicinal products in a no deal scenario」
https://www.gov.uk/guidance/guidance-on-new-provisions-for-traditional-herbal-medicinal-products-and-homoeopathic-medicinal-products-in-a-no-deal-scenario
lHow UK orphan medicinal products will be managed in a no deal scenario」
https://www.gov.uk/guidance/how-uk-orphan-medicinal-products-will-be-managed-in-a-no-deal-scenario
l「How renewals of Marketing Authorisations will be handled in a no deal scenario」
https://www.gov.uk/guidance/how-renewals-of-marketing-authorisations-will-be-handled-in-a-no-deal-scenario
l「Guidance on pharmacovigilance procedures in the event the UK leaves the EU without a deal」
https://www.gov.uk/government/publications/guidance-on-pharmacovigilance-procedures-in-the-event-the-uk-leaves-the-eu-without-a-deal
l「Converting Centrally Authorised Products (CAPs) to UK Marketing Authorisations (MAs) in a no deal scenario, 'grandfathering' and managing lifecycle changes」
https://www.gov.uk/guidance/converting-centrally-authorised-products-caps-to-uk-marketing-authorisations-mas-in-a-no-deal-scenario-grandfathering-and-managing-lifecycle-ch
l「Guidance on how variations to Marketing Authorisations (MAs) will be handled after exit day if the is no deal」
https://www.gov.uk/government/organisations/latest?organisations%5B%5D=medicines-and-healthcare-products-regulatory-agency
l「Guidance on Reference Medicinal Products (RMPs) if the UK leaves the EU without a deal」
https://www.gov.uk/guidance/guidance-on-reference-medicinal-products-rmps-if-the-uk-leaves-the-eu-without-a-deal
l「Guidance note on new assessment routes in a no deal scenario」
https://www.gov.uk/guidance/guidance-note-on-new-assessment-routes-in-a-no-deal-scenario
l「Guidance on handling of Decentralised and Mutual Recognition Procedures in a no deal scenario」
https://www.gov.uk/guidance/guidance-on-handling-of-decentralised-and-mutual-recognition-procedures-in-a-no-deal-scenario
l「Guidance on the handling of applications for Centrally Authorised Products (CAPs) pending on exit day」
https://www.gov.uk/guidance/guidance-on-the-handling-of-applications-for-centrally-authorised-products-caps-pending-on-exit-day
l「Guidance on Converting Parallel Distribution Notices (PDNs) to UK Parallel Import Licences (PILs) in a no deal scenario」
https://www.gov.uk/guidance/guidance-on-converting-parallel-distribution-notices-pdns-to-uk-parallel-import-licences-pils-in-a-no-deal-scenario
l「Handling of Active Substance Master Files and Certificates of Suitability in the event of no deal」
https://www.gov.uk/guidance/handling-of-active-substance-master-files-and-certificates-of-suitability-in-the-event-of-no-deal
l「Guidance on Marketing Authorisation Applications submitted to the UK that have been referred under Article 29 in a no deal scenario」
https://www.gov.uk/guidance/guidance-on-marketing-authorisation-applications-submitted-to-the-uk-that-have-been-referred-under-article-29-in-a-no-deal-scenario
Brexit自体の延期の可能性も踏まえてか、
興味のある方は、下記URLs（更新については前回と同じ）
［全体のウェブサイト］
l更新「MHRA guidance and publications on a possible no deal scenario」
https://www.gov.uk/government/
［今回の更新および追加］
l更新「Exporting active substance manufacturer in the UK if we leave the EU without a deal」
https://www.gov.uk/government/
l「Licensing of biological products: biosimilars, ATMPs and PMFs in a no deal scenario」
https://www.gov.uk/guidance/
l「Guidance on new provisions for traditional herbal medicinal products and homoeopathic medicinal products in a no deal scenario」
https://www.gov.uk/guidance/
lHow UK orphan medicinal products will be managed in a no deal scenario」
https://www.gov.uk/guidance/
l「How renewals of Marketing Authorisations will be handled in a no deal scenario」
https://www.gov.uk/guidance/
l「Guidance on pharmacovigilance procedures in the event the UK leaves the EU without a deal」
https://www.gov.uk/government/
l「Converting Centrally Authorised Products (CAPs) to UK Marketing Authorisations (MAs) in a no deal scenario, 'grandfathering' and managing lifecycle changes」
https://www.gov.uk/guidance/
l「Guidance on how variations to Marketing Authorisations (MAs) will be handled after exit day if the is no deal」
https://www.gov.uk/government/
l「Guidance on Reference Medicinal Products (RMPs) if the UK leaves the EU without a deal」
https://www.gov.uk/guidance/
l「Guidance note on new assessment routes in a no deal scenario」
https://www.gov.uk/guidance/
l「Guidance on handling of Decentralised and Mutual Recognition Procedures in a no deal scenario」
https://www.gov.uk/guidance/
l「Guidance on the handling of applications for Centrally Authorised Products (CAPs) pending on exit day」
https://www.gov.uk/guidance/
l「Guidance on Converting Parallel Distribution Notices (PDNs) to UK Parallel Import Licences (PILs) in a no deal scenario」
https://www.gov.uk/guidance/
l「Handling of Active Substance Master Files and Certificates of Suitability in the event of no deal」
https://www.gov.uk/guidance/
l「Guidance on Marketing Authorisation Applications submitted to the UK that have been referred under Article 29 in a no deal scenario」
https://www.gov.uk/guidance/
執筆者について
古田土 真一
経歴
GMDPコンサルタント（Pharmaceutical Quality Science Advisor） 1979年より田辺製薬(株)(現田辺三菱製薬)にて合成探索研究、プロセス・工業化研究、CMCプロジェクト開発、治験薬QA、コーポレートQAを歴任。2008年より武州製薬(株)にてQA/QCの管理監督。2009年より中外製薬(株)にて治験薬・医薬品のQA業務・品質システムを改革推進。2013年よりアステラス・アムジェン・バイオファーマ(株)にてCMC・Supply Chain・QAの長として業務構築。2015年より三井倉庫ホールディングス(株)にてヘルスケア製品の事業開発アドバイザーとして業務構築。2015年9月より (国立研究開発法人) 国立精神・神経医療研究センター／トランスレーショナル・メディカルセンター臨床研究支援部アドバイザーとして医薬品開発を、また2022年11月からジェダイトメディスン(株)の品質アドバイザーとして医薬品上市を支援中。
医薬品の開発から上市・保管・流通までを品質の側面から一貫した経験を活かし、GMDPコンサルタントとしてGood Practicesの支援依頼に対応中。
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