The emc contains regulated and approved information on medicines available in the UK
- Summaries of Product Characteristics (SPC or SmPC)
- Patient Information Leaflets (PIL) / Package Leaflets (PL)
- Risk Minimisation Materials (RMM)
- Letters to Healthcare Professionals
- Live Chat
- Audio / Video
- User Manual
- Safety Alerts
- Product Information
An SmPC tells healthcare professionals - such as doctors, pharmacists, and nurses - how to prescribe and use a medicine correctly.
An SmPC is based on clinical trials that a pharmaceutical company has carried out and gives information about dose, usage, and possible side effects.
An SmPC is always written in a standard format.
For more information, see our glossary.
A PIL is the leaflet that is included in the pack with a medicine. The PIL is a summary of the SmPC and is written for patients.
For more information, see our glossary.
Risk Minimisation Materials are part of a suite of measures that aim to optimise the safe and effective use of a medicine.
For more information, see our glossary.
Letters to HCPs are direct communications to healthcare professionals to aid education and risk management. Their aim is to ensure the safe and effective use of a marketed medicine.
Live chat functionality is provided by the marketing authorisation holder, or manufacturer of a medicine.
It is for healthcare professionals, and sometimes patients, to contact the company’s Medical Information department with questions about their medicines.
Audio and video content provides additional information in a user friendly way to promote the safe and effective use of a medicine. They may demonstrate how to administer a medicine or improve the accessibility of the information, such as for the blind or visually impaired.
Similar to an audio/video file, the user manual provides a guide to using certain medicine administration methods, such as an EpiPen.
The User Manual is primarily for patient use and provides written instructions and diagrams on the administration.
Safety alerts are issued by the Regulator and/or Marketing Authorisation holder.
They contain important public health messages or safety-critical information about a medicine.
This is additional, important information about a product such the change of ownership of a medicine, package related information, or stock issues.