Category Archives: Medicines

Easing Barriers for Medicines

in Goods Trade, Medicines

ANNEX TBT-2: MEDICINAL PRODUCTS Article 1: Definitions 1. For the purposes of this Annex: (a) “authority” means an authority of a Party as listed in Appendix A; (b) “Good Manufacturing Practice” or “GMP” ...

Vitimins Register UK Post-Deal Guidance

in Medicines, UK Post-Deal Published Guidance

Guidance Great Britain register on the addition of vitamins and minerals and of certain other substances to foods Published 31 December 2020 Contents 1.Section A: vitamins and minerals that may be added to foods ...

Investigational Medicines NI UK Post-Deal Guidance

in Medicines, NI Goods Standards, UK Post-Deal Published Guidance

Guidance Supplying investigational medicinal products to Northern Ireland What you need to do to supply investigational medicinal products (IMPs) from Great Britain to Northern Ireland. Published 31 December 2020 ...

Supplying Medicines NI UK Post-Deal Guidance

in Medicines, NI Goods Standards, UK Post-Deal Published Guidance

Guidance Supplying authorised medicines to Northern Ireland What you need to do to supply authorised medicines from Great Britain to Northern Ireland. Published 31 December 2020 From: Medicines and Healthcare ...

Medical Devices Reg UK Post-Deal Guidance

in Medicines, UK Post-Deal Published Guidance

Guidance Regulating medical devices in the UK What you need to do to place a medical device on the Great Britain, Northern Ireland and European Union (EU) markets. Published 31 December 2020 From: Medicines and ...

Med Devices UK Approved Bodies Post-Deal Guidance

in Medicines, UK Post-Deal Published Guidance

Guidance Medical devices: UK approved bodies UK approved bodies listed under Medical Devices Regulations 2002 (SI 2002 No 618, as amended) (UK MDR 2002). Published 1 January 2021 Last updated 1 January 2021 — see all ...

Orphan Medicines UK Post-Deal Guidance

in Health, Medicines, UK Post-Deal Published Guidance

Guidance Orphan medicinal products in Great Britain The MHRA will review applications for orphan designation at the time of a marketing authorisation (MA) or variation application. Published 31 December 2020 From: ...

Converting Marketing Authorisations UK Post-Deal G

in Medicines, UK Post-Deal Published Guidance

Guidance Converting Centrally Authorised Products (CAPs) to UK Marketing Authorisations (MAs), ‘grandfathering’ and managing lifecycle changes This guidance covers ‘grandfathering’ and managing the ...

Blood & Blood Products UK Post-Deal Guidance

in Health, Medicines, UK Post-Deal Published Guidance

Guidance Quality and safety of human blood and blood products What blood establishments, blood banks and manufacturers of blood products need to do to ensure the safety and quality of blood and blood products. ...

MHRA Procedures UK Post-Deal Guidance

in Medicines, UK Post-Deal Published Guidance

Guidance Register to make submissions to the MHRA Submissions related to human medicines need to be submitted directly to the MHRA. Published 31 December 2020 From: Medicines and Healthcare products Regulatory Agency ...

Clinical Trials UK Post-Deal Guidance

in Medicines, UK Post-Deal Published Guidance

Guidance Registration of clinical trials for investigational medicinal products and publication of summary results This guidance contains information about registration of clinical trials, publishing trial results ...

Varying Marketing Authorisation UK Post-Deal Guida

in Medicines, UK Post-Deal Published Guidance

Guidance Variations to Marketing Authorisations (MAs) How the MHRA processes variations to Marketing Authorisations (MAs) Published 31 December 2020 From: Medicines and Healthcare products Regulatory Agency Contents ...

NI EU Medicines Authorisations UK Post-Deal Guidan

in Medicines, UK Post-Deal Published Guidance

Guidance Procedural advice for Northern Ireland on applications for European Commission Centralised Marketing Authorisations Processes for marketing authorisations granted before 31 December 2020, or submitted or ...

Medicines Marketing Authorisations UK Post-Deal Gu

in Medicines, UK Post-Deal Published Guidance

Guidance Renewing Marketing Authorisations for medicines How to renew marketing authorisations for products granted through different routes and at different times. Published 31 December 2020 From: Medicines and ...

Pharmacovigilance Procedures UK No-Deal Guidance

in Medicines, UK Post-Deal Published Guidance

Guidance Guidance on pharmacovigilance procedures Published 31 December 2020 Contents 1.1. General Approach to the operation of pharmacovigilance 2.2. Actions for submitting and receiving ICSRs 3.3. Signal detection ...

Medical Packaging UK Post-Deal Guidance

in Medicines, UK Post-Deal Published Guidance

Guidance Registering new packaging information for medicines How and when to register updated packaging and information leaflets when new national marketing authorisations have been issued Published 31 December 2020 ...

Medicines Marketing Authorisations UK Post-Deal Gu

in Medicines, UK Post-Deal Published Guidance

Guidance Rolling review for marketing authorisation applications How the rolling review process for marketing authorisation applications will work, and how to apply. Published 31 December 2020 From: Medicines and ...

Medicines Authorisations UK Post-Deal Guidance

in Medicines, UK Post-Deal Published Guidance

Guidance Variations to Marketing Authorisations (MAs) from 1 January 2021 How the MHRA will process variations to Marketing Authorisations (MAs) from 1 January 2021. Published 27 October 2020 Last updated 29 December ...

NI Medicines CMAs UK Post-Deal Guidance

in Medicines, UK Post-Deal Published Guidance

Guidance Procedural advice for Northern Ireland on applications for European Commission Centralised Marketing Authorisations from 1 January 2021 Processes for marketing authorisations granted before 31 December 2020, ...

MHRA Approach Recognition Approval 2021 UK Guidanc

in Medicines, UK Post-Exit Guidance Notes [2020]

Guidance Guidance on handling of Decentralised and Mutual Recognition Procedures approved or pending on 1 January 2021 The approach the MHRA intends to take for products approved or pending in decentralised procedure ...

MHRA Submissions Registration 2021 UK Guidance

in Medicines, UK Post-Exit Guidance Notes [2020]

Guidance Registering to make submissions to the MHRA from 1 January 2021 Submissions related to human medicines would need to be submitted directly to the MHRA. Published 1 September 2020 Last updated 23 December ...

MHRA Submissions Registration 2021 UK Guidance

in Medicines, UK Post-Exit Guidance Notes [2020]

Guidance Registering to make submissions to the MHRA from 1 January 2021 Submissions related to human medicines would need to be submitted directly to the MHRA. Published 1 September 2020 Last updated 23 December ...

Clinical Trial Notices 2021 UK Guidance

in Medicines, UK Post-Exit Guidance Notes [2020]

GuidanceGuidance on submitting clinical trial safety reports from 1 January 2021 How to submit Suspected Unexpected Serious Adverse Drug Reactions (SUSARs) and annual safety reports Development Safety Update Reports ...

Clinical Trial Notices 2021 UK Guidance

in Medicines, UK Post-Exit Guidance Notes [2020]

GuidanceGuidance on submitting clinical trial safety reports from 1 January 2021 How to submit Suspected Unexpected Serious Adverse Drug Reactions (SUSARs) and annual safety reports Development Safety Update Reports ...

Medical Authorisation Location 2021 UK Guidance

in Medicines, UK Post-Exit Guidance Notes [2020]

Guidance Guidance on MAH and QPPV location from 1 January 2021 The locations for a Marketing Authorisation Holder (MAH) and a Qualified Person responsible for Pharmacovigilance (QPPV) after the end of the transition ...

Medical Authorisation Location 2021 UK Guidance

in Medicines, UK Post-Exit Guidance Notes [2020]

Guidance Guidance on MAH and QPPV location from 1 January 2021 The locations for a Marketing Authorisation Holder (MAH) and a Qualified Person responsible for Pharmacovigilance (QPPV) after the end of the transition ...

Medical Devices Registration 2021 UK Guidance

in Health, Medicines, UK Post-Exit Guidance Notes [2020]

Guidance Register medical devices to place on the market from 1 January 2021 How to register your medical devices with the Medicines and Healthcare products Regulatory Agency (MHRA) for the markets in Great Britain ...

Converting Medicine Authorisations 2021 UK Guidanc

in Medicines, UK Post-Exit Guidance Notes [2020]

Guidance Converting Centrally Authorised Products (CAPs) to UK Marketing Authorisations (MAs) from 1 January 2021, ‘grandfathering’ and managing lifecycle changes This guidance covers ‘grandfathering’ and ...

Medical Device Manufacturers 2021 UK Guidance

in Medicines, UK Post-Exit Guidance Notes [2020]

Guidance Register as a manufacturer to sell medical devices from 1 January 2021 How to register your medical devices with the Medicines and Healthcare products Regulatory Agency (MHRA) for the markets in Great ...

Veterinary Medicines 2021 UK Guidance

in Food and Agriculture, Medicines, UK Post-Exit Guidance Notes [2020]

Guidance From 1 January Veterinary Medicines Regulations explainer Guidance on the UK Veterinary Medicines Regulations from 1 January 2021. Published 2 December 2020 From: Veterinary Medicines Directorate Contents ...