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Publications and consultations

Welcome to the publications section.

We produce a range of publications, most of which are aimed at healthcare professionals or people working in the device or pharmaceutical industries. Some are available in full text as pdf documents.


Latest publications

09 Feb 2012 | Medical Device Alert: Reagents requiring manual handling for use in combination with Cobas c501/502 analyser manufactured by Hitachi (MDA/2012/004)

This Medical Device Alert has been issued because the use of insufficient volumes of reagent may lead to a false negative result leading to patient harm.

09 Feb 2012 | Class 3 Drug Alert: Teva UK Limited - Alendronic Acid 10mg Tablets - EL(12)A/06

During non-routine testing 10 months after manufacture, some samples were found to be marginally out of specification for assay. This finding is not expected to impact on patient safety at this stage but there are concerns about potential effects on potency of the batch during the remainder of the shelf-life.

07 Feb 2012 | Class 4 Drug Alert: Updated information for our alerts EL(11)A/32 of 21 December 2011 and EL(12)A/01 of 11 January 2012 - EL(12)A/05

Following our alerts EL(11)A/32 issued on 21 December 2011 and EL(12)A/01 issued on 11 January 2012, B.Braun Medical Ltd  have advised us that they need to release additional batches of  the above NuTRIflex Lipid products which may contain particulates and should be subject to the same additional filtration process previously recommended during infusion.

06 Feb 2012 | Monthly list of MDAs 2012

A month-by-month list of Medical Device Alerts that we have issued in 2012.

06 Feb 2012 | PDF file (opens in new window) Lormetazepam 0.5 and 1 mg Tablets - PL 17507/0131-2 (765Kb)

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Corporate publications

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This section includes all our corporate publications, including our annual reports, corporate plans, business plans and our framework document.

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Consumer publications

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This section includes publications to provide guidance to consumers on the safe use of medicines and medical devices.

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Safety guidance

Guidance documents

This section includes the wide range of documents we produce which provide guidance on safety issues concerning medicinces and medical devices.

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Regulatory guidance

Guidance documents

This section includes the wide range of publications we produce to provide guidance to industry on the regulation of devices and medicines.

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Consultations

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The MHRA formally consults organisations representing public and professional interests, trade associations and industry on proposed statutory changes and other matters of importance.

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Public Assessment Reports (PARs)

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The MHRA makes assessment reports available for all new licences for medicines granted after 30 October 2005, albeit with commercially or personally confidential information removed.

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Posters and leaflets

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This section includes our range of posters and leaflets which complement our more comprehensive guidance documents.

Go to posters and leaflets

Page last modified: 12 July 2011