Regulatory News

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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EMA Distant Assessment Guidance

EMA has published a Guidance document, providing points for consideration relating to Distant Assessments.

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EMA Publishes New Q&A Guide on Brexit

There are only a few days left until the UK will leave the EU. On 01. January 2021 the UK will be considered a "Third Country" with massive consequences for the GMP environment for medicinal products and APIs. Now the EMA published a new Question and Answer Document which clarifies a number of questions which have been raised during the Brexit negotiations. Please read more about EMAs Q&A Document

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Brexit: Phased Process for implementing Medicines Regulation in Northern Ireland

An agreed approach had been reached on a phased process for implementing medicines regulation in Northern Ireland up to 31 December 2021.

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WHO Draft Document on GMP for IMPs

In view of recent experiences from inspections carried out for COVID-19 therapeutics, the World Health Organization (WHO) published a new working document entitled "GOOD MANUFACTURING PRACTICES FOR INVESTIGATIONAL PRODUCTS".

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