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The Hungarian Competent has approved a temporary authorisation for Covid 19 vaccines

The Hungarian Competent has approved a temporary authorisation for Covid 19 vaccines

by Jackie (née Heneghan) Peck | Jan 22, 2021 | Blog, Brexit

The Hungarian Authority, OGYÉI granted a…

Start 2021 with Responsible Person Import training

Start 2021 with Responsible Person Import training

by Sally Finlayson | Jan 20, 2021 | Brexit, RP, Training

We are no longer officially part of the EU, therefore new rules and…

Do UK MA in the EU have to Serialise the packs for the UK Market when GB does require the packs to be serialised?

Do UK MA in the EU have to Serialise the packs for the UK Market when GB does require the packs to be serialised?

by Jackie (née Heneghan) Peck | Jan 14, 2021 | Blog, FMD

he UK MAs currently cover the whole of the “UK” so the UK MAs include Northern Ireland Supply…

The “Safety features” element of EUFMD (FMD2011/62/EU) and Delegated Regulation (20016/161) What Pharmacies in GB need to know and do?

The “Safety features” element of EUFMD (FMD2011/62/EU) and Delegated Regulation (20016/161) What Pharmacies in GB need to know and do?

by Jackie (née Heneghan) Peck | Jan 14, 2021 | Blog, FMD

Lets start with the definition GB is now only…

The “Safety features” element of EUFMD (FMD2011/62/EU) and Delegated Regulation (20016/161) What Pharmacies in Northern Ireland (NI) need to know and do?

by Jackie (née Heneghan) Peck | Jan 14, 2021 | Blog, FMD

For Northern Irish Pharmacies FMD requirements have not changed and they must continue to verify and decommission their “2D” barcoded packs…

The True Cost of Brexit to the UK public

by Jackie (née Heneghan) Peck | Dec 17, 2020 | Blog, Brexit, FMD

The Pharmaceutical Industry in the UK has been hit by the massive increase in the cost of Regulatory Changes. The pharmacy companies in the UK may suffer with the loss of EU collaborative research. There is uncertainty what the effect on no MRA and no FMD will be in...
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Recent Posts

  • FDA Warning Letters
  • Emerging issues – Communique from the GPhC
  • New MHRA/NICE Collaboration

Upcoming Courses

  • RP Forum – GxP Certificates for Customers and Supplier Qualification on 9 September 2025 10:00 am
  • 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

MHRA Alerts & Recalls

Field Safety Notices: 11 to 15 August 2025
19 August 2025
Class 4 Medicines Defect Notification: Levetiracetam Accord 100mg/ml oral solution, Accord Healthcare Limited, UK, EL(25)A/40
14 August 2025
Field Safety Notices: 4 to 8 August 2025
12 August 2025
Class 4 Medicines Defect Notification: Topiramate Zydus Pharmaceuticals UK 20mg/ml Oral Solution, Zydus Pharmaceuticals UK Ltd, EL(25)A/39
7 August 2025

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