Public assessment reports

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The public assessment reports provided are compiled and edited in accordance with EC Directive 2004/27/EC

In accordance with the directive, MHRA makes a scientific assessment report called a Public Assessment Report (PAR) available for new marketing authorisations granted after 30 October 2005. This is based on the MHRA assessment report with any commercially or personally confidential information removed. Subsequent non-safety changes (variations) of clinical significance for each marketing authorisation are provided at the end of each PAR as separate annexes. Minor changes to a marketing authorisation, for example, changes in pack sizes and minor updates to the product literature, may not be represented in the PAR. See below for how we provide details of significant safety changes to a marketing authorisation. MHRA also publish PARs for all marketing authorisation applications that were refused after 1 April 2019.


The current Summary of Product Characteristics (SmPC) and Patient Information Leaflet (PIL) for any granted marketing authorisation are available on our medicines information portal. (Note: Product information included in the PARs may not be the same as the product information available on our medicines information portal. This is due to the date of publication of the PAR).  


For some medicines licensed at a European level, the PARs are prepared by either the European Medicines Agency (EMA) or the responsible authority of another EU member state. The PARs for these medicines can be found on the following websites:

Safety public assessment reports

MHRA monitors the safety of all medicines and vaccines on the market in the UK.


Since the EU pharmacovigilance legislation came into effect in 2012, most safety issues are now assessed at a European level. Public assessment reports for these safety issues can be found on the following websites:


To keep healthcare professionals and the public informed about updated safety advice for medicines we continue to produce post licensing safety PARs for a small number of cases where significant national regulatory action has been taken.

These safety PARs explain the regulatory decisions about the safety of a medicine made by MHRA and include clinical data and scientific assessments.
 

View the safety PARs

 

This page lists the latest 50 public assessment reports that have been published. If you are looking for a specific report please use the search on the left

Latest 50 public assessment reports


Page last modified: 30 May 2019