英国MHRA/Brexit No-deal(合意なき離脱)に伴う通知とウェブサイトの更新(2019年3月19日付)

3/11付・3/12付・3/18付に続いて、3/19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。
ほとんどが、以前にお伝えした案件の更新です。
 
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「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更新「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
 
l更新「How 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更新「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更新「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更新「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更新「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更新「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更新「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更新「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更新「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更新「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更新「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
 
 
また、ここのところのBrexitに伴うガイダンスの発出・更新について、3/19付のRAPSが「New Batch of MHRA No-Deal Brexit Guidance for Drugs, Devices」と題して記事に取り上げています。
興味のある方は、合せて下記URLのニュース記事をご参照ください。
https://www.raps.org/news-and-articles/news-articles/2019/3/new-batch-of-mhra-no-deal-brexit-guidance-for-drug
 

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