Good distribution practice

Helping us to help you – 5 top tips for making enquiries to the MHRA Inspectorate

Chris Gray, 19 November 2015 - Compliance matters, Good clinical practice, Good distribution practice, Good laboratory practice, Good manufacturing practice, Good pharmacovigilance practice, Inside the Inspectorate

The MHRA Inspectorate receives several hundred enquiries via email each year. Answering queries is one of the key ways we support industry. It provides reassurance to our stakeholders, aiding them in their decision-making processes, helping to ensure they don’t fall …

Supply of unlicensed medicines when an equivalent licensed product becomes available

Mark Birse, 9 October 2015 - Compliance matters, Good distribution practice, Good manufacturing practice

We've had a number of instances where licensed versions of commonly supplied unlicensed medicines have become available. We want to remind stakeholders what to do if this happens. Recent examples of newly licensed products of this nature include fomicyt, 40mg/ml fosfomycin …

Importation of unlicensed medicines and centrally authorised products - a helpful reminder

Mark Birse, 23 July 2015 - Compliance matters, Good distribution practice, Good manufacturing practice

We have recently had a number of situation where importers of unlicensed medicines have attempted to notify MHRA of centrally authorised products for import as unlicensed medicines. This is not appropriate, as these are not unlicensed medicines and should be distributed …

Educating and engaging through our symposia

Mark Birse, 7 July 2015 - Events and symposia, Good clinical practice, Good distribution practice, Good laboratory practice, Good manufacturing practice, Good pharmacovigilance practice

A highlight of our work is when we get to engage with you through our symposia. It is a rewarding opportunity for us to keep many hundreds of you – our stakeholders - up to date with the latest regulatory …

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