This section of the website is a gateway for medicines information, bringing together different types of information that outline the properties, safety profile, and conditions for use of a particular medicine. It has been developed in accordance with Directive 2010/84/EU (the new pharmacovigilance legislation).
The MHRA holds data for medicines that are licensed at a national level. Some medicines are licensed centrally by the European Medicines Agency (EMA). For product information on these medicines, please consult the EMA website:
European Medicines Agency (external link)
If you have any questions or comments on this list of product information, please contact our Customer Services Team, email: firstname.lastname@example.org, telephone: 020 3080 6000.
Drug Analysis Prints (DAPs)
Public Assessment Reports
The MHRA’s assessment of a medicine is available in a Public Assessment Report (PAR), albeit with commercially or personally confidential information removed. PARs are typically prepared for products that were granted licences after 30 October 2005. We also publish safety Public Assessment Reports, which summarise the evaluation of a safety issue that has been identified with a medicine and the action taken to ensure that any risks are minimised and the benefits always outweigh them.
Summaries of Risk Management Plans
A Risk Management Plan (RMP) is a document which describes all the available knowledge about the safety and efficacy of a medicinal product.
Drug Safety Update (DSU)
Drug Safety Update is our monthly newsletter for healthcare professionals, bringing you information and clinical advice on the safe use of medicines.
Summaries of Product Characteristics (SPCs) and patient information leaflets (PILs)
This page contains product information. Every medicine pack includes a patient information leaflet (PIL), which provides information on using the medicine safely. PILs are based on the Summaries of Product Characteristics - a description of a medicinal product’s properties and the conditions for its use.
The Yellow Card Scheme is run by the MHRA and the Commission on Human Medicines (CHM), and is used to collect information from both health professionals and the general public on suspected side effects or ADRs to a medicine. Its continued success depends on the willingness of people to report suspected ADRs.