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About this service

SPC-PILs

Patient information leaflet (PILs) are found in every medicine pack, and provide information on how a medicine should be used safely.

Summaries of Product Characteristics (SPCs) are a description of a medicinal product’s properties and the conditions attached to its use. A PIL will be based on an SPC.

We publish the most up-to-date information for a medicine according to its licence history. PILs can be updated several times during the product’s lifecycle, so the leaflet a patient gets with their medicine could be different to the one found here.

We hold data for medicines licensed at a national (UK) level. Some medicines are licensed by the European Medicines Agency (EMA). For product information on these medicines, use the EMA website.

Once a marketing authorisation has been cancelled, the product information will stay on the website for a year.

Market authorisation holders have 6 months to exhaust stocks after they cancel their product. This means the PILs will still be available on the website during this period, with an extra 6 months for patients who still have the product at home.

If you have any questions or comments on this list of product information, please contact our Customer Services Team.

PARs

We make scientific assessment reports called PARs (Public Assessment Reports) for new marketing authorisations granted after 30 October 2005.

We also publish PARs for all marketing authorisation applications that were refused after 1 April 2019.

PARs are published and edited in accordance with a specific EC Directive, 2004/27/EC.

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:

European Medicines Agency (EMA)

Head of Medicines Agency

Changes to PARs

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.

We also publish Safety Public Assessment Reports, which provide details of significant safety changes to a marketing authorisation.