3/11付で英国MHRAからBrexit No-deal（合意なき離脱）に伴う通知が多数発出されています。
興味のある方は、下記URL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「MHRA guidance and publications on a possible no deal scenario」～同日(3/11)のうちに2度更新されています。
https://www.gov.uk/government/collections/mhra-guidance-and-publications-on-a-possible-no-deal-scenario
［Importing and exporting関連］
l「Importing medicines from an EEA State which is on an approved country for import list」
https://www.gov.uk/government/publications/importing-medicines-from-an-eea-state-which-is-on-an-approved-country-for-import-list
l「List of approved countries for authorised human medicines in a no deal scenario」
https://www.gov.uk/government/publications/list-of-approved-countries-for-authorised-human-medicines-in-a-no-deal-scenario
l「Guidance on importation of investigational medicinal products from approval countries」
https://www.gov.uk/government/publications/guidance-on-importation-of-investigational-medicinal-products-from-approval-countries
l「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「Guidance on air freight of medicines in a no deal scenario」
https://www.gov.uk/government/publications/guidance-on-distribution-and-importation-of-medicines-and-active-substance-from-approved-countries
l「Guidance on distribution and importation of medicines and Active Substance from approved countries」
https://www.gov.uk/government/publications/guidance-on-distribution-and-importation-of-medicines-and-active-substance-from-approved-countries
［Vigilance and risk management関連］
l「Completed Paediatric Studies – submission, processing and assessment in the event of a no deal scenario」
https://www.gov.uk/guidance/completed-paediatric-studies-submission-processing-and-assessment-in-the-event-of-a-no-deal-scenario
［Regulatory submissions and vigilance activities関連］
l「Making submissions to the MHRA in a no deal scenario」
https://www.gov.uk/guidance/making-submissions-to-the-mhra-in-a-no-deal-scenario
なお、関連トピックとしては、3/7付GMP Platformトピック「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7日付）」としてお伝えしています。
また、これらに関して、3/11付RAPS「UK’s MHRA Offers 6 New No-Deal Brexit Guidances on Importing, Exporting Medicines」と題して記事に取り上げています。
関係者及び興味のむある方は、下記URLのニュース記事を合せてご参照ください。
https://www.raps.org/news-and-articles/news-articles/2019/3/uks-mhra-offers-6-new-no-deal-brexit-guidances-on
興味のある方は、下記URLのウェブサイト並びにサイト内のリン
［全体のウェブサイト］
l「MHRA guidance and publications on a possible no deal scenario」～同日(3/11)のうちに2度更新されてい
https://www.gov.uk/government/
［Importing and exporting関連］
l「Importing medicines from an EEA State which is on an approved country for import list」
https://www.gov.uk/government/
l「List of approved countries for authorised human medicines in a no deal scenario」
https://www.gov.uk/government/
l「Guidance on importation of investigational medicinal products from approval countries」
https://www.gov.uk/government/
l「Exporting active substance manufacturer in the UK if we leave the EU without a deal」
https://www.gov.uk/government/
l「Guidance on air freight of medicines in a no deal scenario」
https://www.gov.uk/government/
l「Guidance on distribution and importation of medicines and Active Substance from approved countries」
https://www.gov.uk/government/
［Vigilance and risk management関連］
l「Completed Paediatric Studies – submission, processing and assessment in the event of a no deal scenario」
https://www.gov.uk/guidance/
［Regulatory submissions and vigilance activities関連］
l「Making submissions to the MHRA in a no deal scenario」
https://www.gov.uk/guidance/
なお、関連トピックとしては、3/7付GMP Platformトピック「英国MHRA／Brexit No-deal（合意なき離脱）
また、これらに関して、3/11付RAPS「UK’s MHRA Offers 6 New No-Deal Brexit Guidances on Importing, Exporting Medicines」と題して記事に取り上げています。
関係者及び興味のむある方は、下記URLのニュース記事を合せて
https://www.raps.org/news-and-
執筆者について
経歴 ※このプロフィールは掲載記事執筆時点での内容となります
コメント
/
/
/
コメント