2019.10.09.WED

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英国MHRA/after Brexitとしての通知と更新(2019年10月9日付)

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執筆者:古田土 真一

※追記更新(2019.10.10)

10/9付で英国MHRAからBrexit後の手続きとして更新通知が多数発出されています。
 
関係者および興味のある方は、下記URLs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。
 
[今回の更新]
lExporting active substances for medicines after Brexit
https://www.gov.uk/government/publications/exporting-active-substance-manufacturer-in-the-uk-if-we-leave-the-eu-without-a-deal
 
lGuidance on qualified person responsible for pharmacovigilance (QPPV) including pharmacovigilance system master files (PSMF) in a no-deal Brexit
https://www.gov.uk/guidance/guidance-on-qualified-person-responsible-for-pharmacovigilance-qppv-including-pharmacovigilance-system-master-files-psmf-if-the-uk-leaves-the-eu-w
 
lGuidance on pharmacovigilance procedures in the event of a no-deal Brexit
https://www.gov.uk/government/publications/guidance-on-pharmacovigilance-procedures-in-the-event-the-uk-leaves-the-eu-without-a-deal
 
lMHRA consultation on EU exit no-deal legislative proposals
https://www.gov.uk/government/consultations/mhra-consultation-on-eu-exit-no-deal-legislative-proposals
 
lGuidance on Marketing Authorisation Applications (MAA) submitted to the UK that have been referred under Article 29 in a no-deal Brexit
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
 
lConverting Parallel Distribution Notices (PDNs) to UK Parallel Import Licences (PILs) in a no-deal Brexit
https://www.gov.uk/guidance/guidance-on-converting-parallel-distribution-notices-pdns-to-uk-parallel-import-licences-pils-in-a-no-deal-scenario
 
lGuidance note on new assessment routes in a no-deal Brexit
https://www.gov.uk/guidance/guidance-note-on-new-assessment-routes-in-a-no-deal-scenario
 
lReference Medicinal Products (RMPs) after Brexit
https://www.gov.uk/guidance/guidance-on-reference-medicinal-products-rmps-if-the-uk-leaves-the-eu-without-a-deal
 
lGuidance on air freight of medicines in a no-deal Brexit
https://www.gov.uk/government/publications/guidance-on-distribution-and-importation-of-medicines-and-active-substance-from-approved-countries
 
lImporting medicines from the EEA after Brexit
https://www.gov.uk/government/publications/importing-medicines-from-an-eea-state-which-is-on-an-approved-country-for-import-list
 
lProcedures for UK Paediatric Investigation Plan (PIPs) in a no-deal Brexit
https://www.gov.uk/guidance/procedures-for-uk-pips-in-the-event-the-uk-leaves-the-eu-without-a-deal
 
lGuidance on new provisions for traditional herbal medicinal products and homoeopathic medicinal products in a no-deal Brexit
https://www.gov.uk/guidance/guidance-on-new-provisions-for-traditional-herbal-medicinal-products-and-homoeopathic-medicinal-products-in-a-no-deal-scenario
 
lCompleted Paediatric Studies  submission, processing and assessment in a no-deal Brexit
https://www.gov.uk/guidance/completed-paediatric-studies-submission-processing-and-assessment-in-the-event-of-a-no-deal-scenario
 
lList of approved countries for authorised human medicines if there is a no-deal Brexit
https://www.gov.uk/government/publications/list-of-approved-countries-for-authorised-human-medicines-in-a-no-deal-scenario
 
lLicensing biosimilars, ATMPs and PMFs after Brexit
https://www.gov.uk/guidance/licensing-of-biological-products-biosimilars-atmps-and-pmfs-in-a-no-deal-scenario
 
lApplying for a Certificate of Pharmaceutical Product after Brexit
https://www.gov.uk/guidance/applying-for-a-certificate-of-pharmaceutical-product-in-a-no-deal-scenario
 
lHandling of Active Substance Master Files and Certificates of Suitability in the event of no-deal Brexit
https://www.gov.uk/guidance/handling-of-active-substance-master-files-and-certificates-of-suitability-in-the-event-of-no-deal
 
lConversion of Community Marketing Authorisations to UK Marketing Authorisations  letters to industry
https://www.gov.uk/government/publications/conversion-of-community-marketing-authorisations-to-uk-marketing-authorisations-letter-to-industry
 
lConditional Marketing Authorisations, exceptional circumstances Marketing Authorisations and national scientific advice if there is a no-deal Brexit
https://www.gov.uk/guidance/conditional-marketing-authorisations-exceptional-circumstances-marketing-authorisations-and-national-scientific-advice-in-a-no-deal-scenario
 
lConversion of existing approved Community Marketing Authorisations to UK Marketing Authorisations (MAs)  letter to industry
https://www.gov.uk/government/publications/conversion-of-existing-approved-community-marketing-authorisations-to-uk-marketing-authorisations-mas-letter-to-industry-and-guidance
 
lApplying for a Certificate of Pharmaceutical Product after Brexit
https://www.gov.uk/guidance/applying-for-a-certificate-of-pharmaceutical-product-in-a-no-deal-scenario
 
lGuidance on registration of clinical trials for investigational medicinal products and publication of summary results in a no-deal Brexit
https://www.gov.uk/guidance/guidance-on-registration-of-clinical-trials-for-investigational-medicinal-products-and-publication-of-summary-results
 
lGuidance on importation of investigational medicinal products from approved countries in a no-deal Brexit
https://www.gov.uk/government/publications/guidance-on-importation-of-investigational-medicinal-products-from-approval-countries
 
lGuidance on handling of Decentralised and Mutual Recognition Procedures in a no-deal Brexit
https://www.gov.uk/guidance/guidance-on-handling-of-decentralised-and-mutual-recognition-procedures-in-a-no-deal-scenario
 
lVariations to Marketing Authorisations (MAs) after Brexit
https://www.gov.uk/guidance/guidance-on-how-variations-to-marketing-authorisations-mas-will-be-handled-after-exit-day-if-the-is-no-deal
 
lHow UK orphan medicinal products will be managed if there is a no-deal Brexit
https://www.gov.uk/guidance/how-uk-orphan-medicinal-products-will-be-managed-in-a-no-deal-scenario
 
lConverting Centrally Authorised Products (CAPs) to UK Marketing Authorisations (MAs) in a no-deal Brexit, '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

ちなみに、直近のGMP Platformトピックとしては、10/5付トピック「英国MHRAafter Brexitとしての通知と更新(2019104日付)としてお伝えしています。


10/10付追記更新】
昨日(10/9)付の本トピックの追加となりますが、英国MHRAからのBrexitに伴う更新通知です。
以下、順不同で列記しますが、関連通知を全て網羅している訳ではありませんこと、予めご容赦ください。
なお、GPvPは以下に挙げていますが、GCPGMDPについては10/10付の別名トピックスとしてお伝えしています。
 
lExceptions and modifications to the EU guidance on good pharmacovigilance practices that will apply in a no-deal Brexit

https://www.gov.uk/government/publications/exceptions-and-modifications-to-the-eu-guidance-on-good-pharmacovigilance-practices-that-will-apply-in-a-no-deal-brexit
 
lRegulating medical devices in the event of a no-deal Brexit

https://www.gov.uk/guidance/regulating-medical-devices-in-the-event-of-a-no-deal-scenario
 
lContingency legislation covering regulation of medicines and medical devices in a no deal scenario

https://www.gov.uk/government/news/contingency-legislation-covering-regulation-of-medicines-and-medical-devices-in-a-no-deal-scenario
 
lRegistering new packaging information for medicines after Brexit

https://www.gov.uk/guidance/updates-to-packaging-components-and-instructions-on-submissions-if-the-uk-leaves-the-eu-without-a-deal-for-those-marketing-authorisations-ma-issued
 
lMHRA guidance and publications about a possible no-deal Brexit

https://www.gov.uk/government/collections/mhra-guidance-and-publications-on-a-possible-no-deal-scenario
 
lGuideline on Paediatric Investigation Plans, waivers, deferrals and compliance check

https://www.gov.uk/government/publications/guideline-on-paediatric-investigation-plans-waivers-deferrals-and-compliance-check
 
lGood pharmacovigilance practice (GPvP) 

https://www.gov.uk/guidance/good-pharmacovigilance-practice-gpvp
 
 
10/10付追記更新】
10/9付のRAPSが「UK Updates on Drug Shortage Plans Ahead of Looming Brexit Deadline」と題して記事に取り上げています。
興味のある方は、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/2019/10/uk-updates-on-drug-shortage-plans-ahead-of-looming
 

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古田土 真一

古田土 真一

三井倉庫ホールディングス株式会社 事業開発室 シニアマネージャー
(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

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6月より現職。医薬品の開発から保管・流通までを品質の側面から一貫して経験。