Regulatory News

What happens when Product is delivered before Release?

A Warning Letter was sent to a company who shipped product without a release.

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Corona: What measures have Governments taken in the Life Sciences Sector?

Governments have been implementing different emergency measures in the fight against the current pandemic. Now an overview of the various measures in the EMEA region has been published.

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Brexit: How to import Medicines into UK

The UK Medicines and Healthcare Products Regulatory Agency (MHRA) has just published a Guidance for Wholesaling and Importing Activities after the end of the Transition Period.

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EU: Checklist for Brexit Preparation

The European Commission has published a 'Brexit Readiness Checklist' for companies doing business with the UK.

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Can the Application of Safety Features be outsourced?

Safety features may be applied by external manufacturers and suppliers. This has now been clarified in a Question and Answer document.

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Brexit is approaching: Regulations for Pharmaceuticals defined

The European Commission has published a communication to prepare for the end of the transition period. There are also indications for the pharmaceutical sector.

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Pharmaceutical Associations underline Importance of MRA with UK

Several European pharmaceutical associations are calling on the EU to give priority to access to medicines in the ongoing Brexit negotiations. Specifically, they are calling for an MRA.

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Seizure and Prison for Owner of Immuno Biotec

After a 15-month prison sentence, the owner of Immuno Biotech is now threatened with the seizure of GBP 1.4 million in connection with the manufacture, sale and supply of an unlicensed drug.

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