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MHRA Guidance: Find Product Information About Medicines

Access to accurate and up-to-date medicinal product information is essential for the safe prescribing, dispensing, and use of medicines. Healthcare professionals rely on authorised product information to make informed clinical decisions, while patients depend on clear instructions to use medicines safely and effectively. Providing easy access to approved regulatory information also promotes transparency throughout a medicine's lifecycle.

The Medicines and Healthcare products Regulatory Agency (MHRA) has revised (10 July 2026) the Find Product Information About Medicines guidance to help healthcare professionals, patients, and members of the public locate authorised medicine information through the MHRA Products website.


Why This Guidance Is Important

Medicinal product information is regularly updated to reflect new scientific evidence, approved variations, safety recommendations, and regulatory decisions. Having access to the latest approved information helps healthcare professionals prescribe medicines appropriately, supports informed patient use, and improves medicine safety.

The MHRA Products service acts as a central source for authorised medicine information in the UK, allowing users to search medicines using product names, active substances, or Product Licence (PL) numbers and access the most current regulatory information available.

Summary of Product Characteristics (SPCs)

The Summary of Product Characteristics (SPC) is the official document describing a medicinal product's properties and the conditions attached to its use. It provides healthcare professionals with detailed scientific and prescribing information, including indications, dosage recommendations, contraindications, warnings, precautions, interactions, pharmacological properties, and storage requirements.


Patient Information Leaflets (PILs)

Every authorised medicine supplied to patients includes a Patient Information Leaflet (PIL), which explains how to use the medicine safely and effectively in language that is easy for patients to understand.

PILs are developed from the approved SPC and provide practical information on medicine use, dosage instructions, precautions, possible side effects, storage recommendations, and guidance on seeking further medical advice.


Public Assessment Reports (PARs)

Public Assessment Reports (PARs) provide scientific summaries of the MHRA's evaluation of medicines that have received new Marketing Authorisations. These reports are based on the Agency's assessment while removing commercially confidential and personal information.

PARs improve regulatory transparency by explaining the evidence supporting medicine approval, including assessments of quality, safety, and efficacy.


Additional Monitoring

Some medicines require enhanced post-authorisation safety monitoring and are therefore placed under additional monitoring. These products are identified by an inverted black triangle displayed in both the Summary of Product Characteristics and the Patient Information Leaflet, together with a statement explaining its significance.

Medicines subject to additional monitoring are monitored particularly closely to encourage the reporting of suspected adverse reactions through the MHRA Yellow Card Scheme. Newly authorised medicines containing new active substances, biological medicines, or products requiring additional pharmacovigilance activities are commonly included in this category. The MHRA regularly updates the UK Additional Monitoring List to reflect medicines currently subject to enhanced safety monitoring.

Accessing Medicine Information

The MHRA Products service enables users to search authorised medicines using product names, active substances, or Product Licence numbers. The database provides direct access to the latest approved SPCs, Patient Information Leaflets, Public Assessment Reports, and other authorised product information based on each medicine's current licensing history.


By making Summary of Product Characteristics, Patient Information Leaflets, Public Assessment Reports, and additional monitoring information readily available, the MHRA supports informed clinical decision-making, promotes transparency, and strengthens the safe and effective use of authorised medicines throughout their lifecycle.

References

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The views expressed in this publication do not necessarily reflect the views of any guidance of government, health authority, it's purely my understanding. This Blog/Web Site is made available by a regulatory professional, is for educational purposes only as well as to give you general information and a general understanding of the pharmaceutical regulations, and not to provide specific regulatory advice. By using this blog site you understand that there is no client relationship between you and the Blog/Web Site publisher. The Blog/Web Site should not be used as a substitute for competent pharma regulatory advice and you should discuss from an authenticated regulatory professional in your state.  We have made every reasonable effort to present accurate information on our website; however, we are not responsible for any of the results you experience while visiting our website and request to use official websites.

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