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The Windsor Framework Part 3

The Windsor Framework Part 3

by Steven Hewison | Aug 29, 2024 | Blog, MHRA, Windsor Framework

Unless they appear on the NIMAR list, PLGB licensed medicines are not licensed in Northern Ireland. That means they are effectively supplied to NI as an Unlicensed ‘Special’.

The Windsor Framework Part 3

The Windsor Framework Part 2

by Steven Hewison | Aug 28, 2024 | Blog, MHRA, Windsor Framework

After the implementation of the Windsor Framework, the Medicines and Healthcare products Regulatory Agency (MHRA) will license all medicines across the whole of the UK’.

The Windsor Framework Part 3

The Windsor Framework Part 1 (recap)

by Steven Hewison | Aug 27, 2024 | Blog, MHRA, Windsor Framework

From the 1st of January 2025 the supply of medicines to Northern Ireland will be governed by the Windsor Framework, which will replace the Northern Ireland Protocol.

Management of Change in your business

Management of Change in your business

by Natalie Harper | Aug 8, 2024 | Blog, MHRA, WDA(H)

Management of change in your business should be a main cornerstone of any robust and functioning Quality Management System (QMS). The main advantages of having a strong change control process within your business include:

Be Careful What You Advertise

Be Careful What You Advertise

by Steven Hewison | Jul 19, 2024 | Blog, MHRA, Pharmacy

Most of us will know that it is illegal to promote prescription only medicines (POMs) to members of the public, however, it is always worth a reminder that you must be careful what you advertise.

Self-Inspections

Self-Inspections

by Craig Webb | Apr 5, 2024 | Blog, MHRA, WDA(H)

Self-Inspections are an important part of GDP and ensuring you keep your activities and licence compliant.

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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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