Regulatory News

UK Recognition of EU/EEA Batch Testing does not end on 1 January 2023

A letter from the UK government to medicines and medical products suppliers extends the transitional phase for the recognition of EU batch tests beyond 2022.

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EU accepts MHRA inspections

The EMA has updated its Q&A document on the implementation of the Protocol on Ireland and Northern Ireland and clarified the recognition of inspections.

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Brexit Guideline from CMDh updated

The Co-ordination Group for Mutual Recognition and Decentralised procedures - Human (CMDh) of the HMA has updated a recently published Guideline on Brexit.

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Updated Guidance on the Management of Clinical Trials during COVID-19

Pragmatic procedures are currently required to ensure the flexibility needed to maintain the integrity of clinical trials during the COVID-19 pandemic. The updated guidance on management of clinical trials during COVID-19 includes adapted approaches for IMP supply and details on remote source data verification.

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New EU Commission Brexit Notice on Medicinal Products

The EU Commission published a new notice in the Official Journal of the EU on 25 January 2021. Although Brexit was a long time coming, there are supply problems for some medicinal products. The Covid-19 pandemic has therefore also prompted the EU to act. Cyprus, Ireland, Malta and Northern Ireland in particular have not yet fully adapted their supply chains.

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EU plans new Health Authority

The European Commission is planning to create a new EU Health Emergency Preparedness and Response Authority (HERA). For this purpose, the Commission has opened a feedback procedure.

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Are QP Remote Certifications allowed?

We keep receiving questions about the extent to which remote QP certifications are possible in the current situation. Unfortunately, the legislation in the individual EU Member States is not uniform.

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Distant Assessment - an Option for the Future?

Due to the current pandemic and the associated restrictions, assessments are increasingly being performed remotely. Are these Distant Assessments also an option for the post-pandemic period?

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Brexit Agreement - what now?

Brexit: The agreement on the future relationship between the European Union and the United Kingdom is here. What are the consequences for medicinal products?

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Avoiding Non-Compliance in Packaging Areas

Filling product into open containers with leaks above the packaging lines? Not a good idea - A current FDA Warning Letter provides information.

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