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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

  • 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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