# Find product information about medicines Source: https://www.keypedia.com/records/uk_mhra_guidance/uk-mhra/732aa48b-18a7-4874-a7ee-bba838cefe44 Type: Detailed Guide Published: December 19, 2019 Updated: June 8, 2026 > This MHRA guidance outlines the UK’s regulatory framework for accessing medicinal information, including Summaries of Product Characteristics (SPC), Patient Information Leaflets (PIL), and Public Assessment Reports (PAR). While the document does not name a specific company or list inspection dates and violations—as it is a general regulatory notice rather than an enforcement report—it establishes critical safety protocols. The guidance details the 'Additional Monitoring' process, identified by a black inverted triangle symbol, which signals that a medicine (often containing a new active substance) is under intense scrutiny for a minimum of five years. Under the Windsor Framework implementation on January 1, 2025, the MHRA converted Great Britain-specific marketing authorizations into UK-wide licenses. The required actions for healthcare professionals and the public involve using the MHRA’s search services to stay informed and reporting all suspected adverse reactions for monitored products via the Yellow Card scheme. This oversight ensures that the Commission on Human Medicines (CHM) can evaluate safety data throughout a product’s lifecycle, particularly during its initial years on the market or following major safety reviews. --- ## Content Healthcare professionals and members of the public can use the MHRA products service using the link below to find: the leaflets which are provided with medicines the description of the medicinal product’s properties and how to use it scientific reports about marketing authorisations for medicines Search medicines You can search for any medicine to find details on how the medicine can be used (SPCs), patient information leaflets (PILs), and scientific reports (PARs). SPCs A summary of product characteristics (SPC) is a description of a medicinal product’s properties and the conditions attached to its use. It explains how to use and prescribe a medicine. It is used by healthcare professionals, such as doctors, nurses and pharmacists. PILs Every medicine pack includes a patient information leaflet (PIL), which provides information on using the medicine safely. PILs are based on information in the SPC of the medicine. PARs A public assessment report (PAR) is 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. We also publish safety public assessment reports Additional monitoring The list of medicines under additional monitoring includes medicines authorised in the UK that are being monitored particularly closely by MHRA. Medicines under additional monitoring have a black inverted triangle displayed in their package leaflet and summary of product characteristics, together with a short sentence explaining what the triangle means. The Commission on Human Medicines (CHM) and the MHRA encourages the reporting via the Yellow Card scheme of all suspected adverse reactions to medicines displaying the black triangle. Typically, medicines containing a new active substance or new biologicals would be subject to additional monitoring at the point of approval of the marketing authorisation and for the next 5 years. After 5 years a medicine would be removed from additional monitoring unless circumstances apply that may necessitate it remaining under additional monitoring (for example, an ongoing mandatory post-authorisation safety study, conditional marketing authorisation). It is also possible that medicines may be placed under additional monitoring post-authorisation during their lifecycle, perhaps as an outcome of a major safety review. The UK additional monitoring list below includes medicines on the EU additional monitoring list that are also authorised in the UK, as well as medicines subject to additional monitoring in the UK but not on the EU list. This provides a comprehensive list of all additionally monitored products licensed in the UK. Additional Monitoring List ( MS Excel Spreadsheet , 278 KB ) Please contact blacktriangle@mhra.gov.uk for enquiries regarding this list. Please note, that following implementation of the Windsor framework on 1 January 2025, all existing Great Britain (GB) marketing authorisations (PLGBs) have been converted to UK-wide marking authorisations but their MA numbers including the PLGB prefix, have not changed. Further information about SPC, PILs and PARs ## Attachments - [Additional Monitoring List](https://assets.publishing.service.gov.uk/media/6a22dbf12cdcfdb7436ac002/Additional_Monitoring_May_2026.xlsx)