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MHRA - GCP Serious Breaches - the 2018 Edition

3rd June 2019

MHRA's GCP Serious Breaches metrics and examples have been released.

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GOOD STORAGE AND DISTRIBUTION PRACTICES

29th May 2019

WHO Document for Consultation GOOD STORAGE AND DISTRIBUTION PRACTICES

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MHRA STEM Minutes

29th May 2019

Minutes and presentations now available.

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Brexit: EU supports pharmaceutical Companies

6th March 2019

Medicinal products imported into the EU must undergo batch testing within the EU and the European Economic Area (EEA)*. Once the United Kingdom (UK) leaves the EU (Brexit), pharmaceutical manufacturers who have previously carried out batch testing in the UK must relocate their batch testing operations to the EU/EEA in order to import their products.

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Brexit: Handling PV Data from the UK

6th March 2019

The European Medicines Agency (EMA) has updated the agency's Brexit-related guidance documents. This guidance is supporting pharmaceutical companies to prepare for the United Kingdom's (UK) withdrawal from the European Union (EU). Now the 'Questions and Answers' document has been updated (Rev 04, published on 1st February 2019). The new Q&As address the situation when the United Kingdom becomes a third country on 30th March 2019 without a withdrawal agreement (and hence without a transition period).

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Brexit-related guidance for companies

25th February 2019

The European Medicines Agency (EMA) and the European Commission are providing guidance to help pharmaceutical companies responsible for both human and veterinary medicines prepare for the United Kingdom's (UK) withdrawal from the European Union (EU), a process known as 'Brexit'.

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MHRA Pharmacovigilance Inspection Metrics

6th February 2019

The MHRA GPvP inspectorate recently published their latest inspection metrics for the period from April 2017 to March 2018.

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EMA - Change of Address

5th February 2019

The EMA London office will close on the 1st March 2019 and re-open on the 4th March in Amsterdam....

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EMA Relocation Updates

23rd January 2019

The European Medicines Agency (EMA) will physically relocate to the Netherlands in early March 2019. The Dutch authorities have already officially handed over the temporary building, the Spark building in Amsterdam Sloterdijk, to EMA’s Executive Director Guido Rasi on 9 January 2019 and EMA is now preparing for its physical move.

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MHRA Guidance in the event of a no-deal Brexit

3rd January 2019

MHRA Guidance on the regulation of medicines, medical devices and clinical trials if there’s no Brexit deal....

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