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Defective Medicinal Products and Recall Management Guidance

Defective Medicinal Products and Recall Management Guidance

by Amelia Holmes | Aug 5, 2022 | Blog, MHRA

The main concerns with regard to possible defects of medicinal products and the substances used in their manufacture or packaging.

Medicinal products seized by MHRA worth just under £1,000,000

Medicinal products seized by MHRA worth just under £1,000,000

by Thomas Currie | Jul 28, 2022 | Blog, MHRA

Medicinal products seized within the week running from the 23rd-30th June, the Medicines and Healthcare products Regulatory Agency (MHRA) seized 285,000 medicines and medical devices which were valued at almost £1,000,000.

Import Licensed Human Medicine(s) to the United Kingdom (UK) – Guidance

Import Licensed Human Medicine(s) to the United Kingdom (UK) – Guidance

by Amelia Holmes | Jul 13, 2022 | Blog, MHRA, WDA(H), WDA(H)

Import Licensed Human Medicine – Prior to importation of a licensed medicine applications for the relevant Licence(s) must be completed and submitted which may include one or more of the following:

Import Unlicensed Human Medicine(s) to the United Kingdom (UK) – guidance

Import Unlicensed Human Medicine(s) to the United Kingdom (UK) – guidance

by Amelia Holmes | Jul 13, 2022 | Blog, Good Distribution Practice - GDP, MHRA, WDA(H)

An Introduced Product is an unlicensed medicine which can be imported from a country other than an approved country for import to be exported to a country other than an approved country for import, or if imported from a non-EEA country into Northern Ireland for export back to a country outside the EEA.

Termination of Licence, Authorisation or Registration

Termination of Licence, Authorisation or Registration

by Chole Greenway | Jul 1, 2022 | Blog, MHRA, WDA(H)

For the distribution of medicines and healthcare products, a licence, authorisation or registration is required depending on the type of activity.

MHRA Green Guide Update 2022

MHRA Green Guide Update 2022

by Sally Cox | May 10, 2022 | Blog, MHRA

There is a new MHRA Green Guide Update 2022 updated edition of the Rules and Guidance for Pharmaceutical Distributors called the MHRA Green Guide.

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Recent Posts

  • Communication from the GPhC regarding Regulatory Concerns
  • Professional Indemnity Insurance
  • FDA Warning Letters

Upcoming Courses

  • Introduction to Good Distribution Practice Online Training on 10 September 2025 10:00 am
  • GDP/RP Cogent Gold Standard Online Training on 16 September 2025
  • GDP Audit Online Training on 1 October 2025 10:00 am
  • Licence Holder Training on 14 October 2025 10:00 am
  • GDP/RP Cogent Gold Standard Online Training on 21 October 2025

MHRA Alerts & Recalls

Field Safety Notices: 1 to 5 September 2025
9 September 2025
Class 4 Medicines Defect Notification: Hikma Farmacêutica, Gemcitabine 2g/52.6ml concentrate for solution for infusion, EL(25)A/43
4 September 2025
Profemur Cobalt Chrome Modular Neck Hip Replacements: Higher than anticipated risk of revision surgery, metal-wear effects and component fracture (DSI/2025/005)
4 September 2025
Field Safety Notices: 25 to 29 August 2025
3 September 2025

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