英国MHRA/2021年1月1日以降における各規制の変更(2020年9月4日付)
9/4付として英国MHRAからの「2021年1月1日以降における各規制の変更 」に関する通知が追加発出されています。
Brexitによる現行対応が本年末に期限を迎えることからの変更対応です。
GMPや品質関連だけではありませんが、英国と輸出入の関係にある企業にあっては、下記ウェブサイトをご確認ください。
Guidance on qualified person responsible for pharmacovigilance (QPPV) including pharmacovigilance system master files (PSMF) from 1 January 2021
また本件に伴い、9/4付のRAPSが「Pharmacovigilance and QPPV: Post-transition guidance from MHRA 」と題して記事に取り上げています。
合せて、ご参照ください。
https://www.raps.org/news-and-articles/news-articles/2020/9/pharmacovigilance-and-qppv-post-transition-guidanc
[以下は、2020年9月1日付としての通知です]
l全体のウェブサイト「Latest from the Medicines and Healthcare products Regulatory Agency: Search」
https://www.gov.uk/search/all?organisations%5B%5D=medicines-and-healthcare-products-regulatory-agency&order=updated-newest&parent=medicines-and-healthcare-products-regulatory-agency
MHRA post-transition period information
Guidance on the handling of applications for Centrally Authorised Products (CAPs) pending on 1 January 2021
List of approved countries for authorised human medicines from 1 January 2021
Procedures for UK Paediatric Investigation Plan (PIPs) from 1 January 2021
Completed Paediatric Studies - submission, processing and assessment from 1 January 2021
Regulating medical devices from 1 January 2021
Reference Medicinal Products (RMPs) from 1 January 2021
Guidance on pharmacovigilance procedures in the event from 1 January 2021
Renewing Marketing Authorisations for medicines from 1 January 2021
Format and content of applications for agreement or modification of a Paediatric Investigation Plan and requests for waivers or deferrals and concerning the operation of the compliance check from 1 January 2021
Guidance on new provisions for traditional herbal medicinal products and homoeopathic medicinal products from 1 January 2021
Guidance on licensing biosimilars, ATMPs and PMFs from 1 January 2021
Comparator products in Bioequivalence/Therapeutic Equivalence studies from 1 January 2021
Registering to make submissions to the MHRA from 1 January 2021
Exporting active substances manufactured in Great Britain for use in EEA and Northern Ireland from 1 January 2021
Webinars: preparing to make submissions to the MHRA from 1 January 2021
Importing investigational medicinal products into Great Britain from approved countries from 1 January 2021
Acting as a Responsible Person (import) from 1 January 2021
How Marketing Authorisation Applications referred under Article 29 will be handled from 1 January 2021
Handling of Active Substance Master Files and Certificates of Suitability from 1 January 2021
Registration of clinical trials for investigational medicinal products and publication of summary results from 1 January 2021
Applying for a Certificate of Pharmaceutical Product from 1 January 2021
Converting Parallel Distribution Notices (PDNs) to UK Parallel Import Licences (PILs) from 1 January 2021
Converting Centrally Authorised Products (CAPs) to UK Marketing Authorisations (MAs) from 1 January 2021, 'grandfathering' and managing lifecycle changes
Guidance on substantial amendments to a clinical trial from 1 January 2021
Registering new packaging information for medicines from 1 January 2021
Importing medicines on an approved country for import list from 1 January 2021
Conditional Marketing Authorisations, exceptional circumstances Marketing Authorisations and national scientific advice from 1 January 2021
Brexitによる現行対応が本年末に期限を迎えることからの変
GMPや品質関連だけではありませんが、
Guidance on qualified person responsible for pharmacovigilance (QPPV) including pharmacovigilance system master files (PSMF) from 1 January 2021
また本件に伴い、9/4付のRAPSが「Pharmacovig
合せて、ご参照ください。
https://www.raps.org/news-and-
[以下は、2020年9月1日付としての通知です]
l全体のウェブサイト「Latest from the Medicines and Healthcare products Regulatory Agency: Search」
https://www.gov.uk/search/all?
MHRA post-transition period information
Guidance on the handling of applications for Centrally Authorised Products (CAPs) pending on 1 January 2021
List of approved countries for authorised human medicines from 1 January 2021
Procedures for UK Paediatric Investigation Plan (PIPs) from 1 January 2021
Completed Paediatric Studies - submission, processing and assessment from 1 January 2021
Regulating medical devices from 1 January 2021
Reference Medicinal Products (RMPs) from 1 January 2021
Guidance on pharmacovigilance procedures in the event from 1 January 2021
Renewing Marketing Authorisations for medicines from 1 January 2021
Format and content of applications for agreement or modification of a Paediatric Investigation Plan and requests for waivers or deferrals and concerning the operation of the compliance check from 1 January 2021
Guidance on new provisions for traditional herbal medicinal products and homoeopathic medicinal products from 1 January 2021
Guidance on licensing biosimilars, ATMPs and PMFs from 1 January 2021
Comparator products in Bioequivalence/Therapeutic Equivalence studies from 1 January 2021
Registering to make submissions to the MHRA from 1 January 2021
Exporting active substances manufactured in Great Britain for use in EEA and Northern Ireland from 1 January 2021
Webinars: preparing to make submissions to the MHRA from 1 January 2021
Importing investigational medicinal products into Great Britain from approved countries from 1 January 2021
Acting as a Responsible Person (import) from 1 January 2021
How Marketing Authorisation Applications referred under Article 29 will be handled from 1 January 2021
Handling of Active Substance Master Files and Certificates of Suitability from 1 January 2021
Registration of clinical trials for investigational medicinal products and publication of summary results from 1 January 2021
Applying for a Certificate of Pharmaceutical Product from 1 January 2021
Converting Parallel Distribution Notices (PDNs) to UK Parallel Import Licences (PILs) from 1 January 2021
Converting Centrally Authorised Products (CAPs) to UK Marketing Authorisations (MAs) from 1 January 2021, 'grandfathering' and managing lifecycle changes
Guidance on substantial amendments to a clinical trial from 1 January 2021
Registering new packaging information for medicines from 1 January 2021
Importing medicines on an approved country for import list from 1 January 2021
Conditional Marketing Authorisations, exceptional circumstances Marketing Authorisations and national scientific advice from 1 January 2021
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