kbnero.blogg.se - Compendium definition

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#Compendium definition license#

It may include important information such as about a change of ownership of the medicine, package related information or stock issues.

This is additional information about a product. Safety alerts are issued by the Regulator and/or marketing authorisation holder and contain important public health messages or safety critical information about a medicine.

#Compendium definition how to#

They may demonstrate how to administer a medicine or improve the accessibility of the information, such as for the blind or visually impaired. Live chat functionality is provided by the marketing authorisation holder, or manufacturer of a medicine, for healthcare professionals, and sometimes patients, to contact the company’s Medical Information department with questions about their medicines.Īudio and video content provides additional information in a user friendly way to promote the safe and effective use of a medicine. Their aim is to ensure the safe and effective use of a marketed medicine. Letters to HCPs are direct communications to healthcare professionals to aid education and risk management. Risk Minimisation Materials are part of a suite of measures that aim to optimise the safe and effective use of a medicine. The PIL is a summary of the SmPC and is written for patients. An SmPC is always written in a standard format, which is explained in our glossary.Ī PIL is the leaflet that is included in the pack with a medicine. An SmPC is based on clinical trials that a pharmaceutical company has carried out, and gives information about dose, use and possible side effects.

Patient Information Leaflets (known as PILs, Package Leaflets or PLs)Īn SmPC tells healthcare professionals, such as doctors, pharmacists and nurses, how to prescribe and use a medicine correctly.

Summaries of Product Characteristics (known as SPCs or SmPCs).

We work with pharmaceutical companies, the NHS, and other healthcare organisations to provide good information about medicines.Įmc contains regulated and approved information on medicines available in the UK

#Compendium definition full#

See the Legal and Privacy Policy for full usage terms.Įmc is managed and owned by Datapharm Ltd. You can search and view medicine information on emc without the need to register. emc therefore continues to hold EMA-approved information during this phased approach to full migration to emc northern ireland.Įmc was launched in 1999 and has become an established website, trusted for reliable information about medicines. This Northern Ireland-specific medicines information can be found on emc northern ireland ( The medicines regulatory authorities have permitted a transition period for EMA licensed information to be updated to MHRA licensed information.

PL – Medicines licensed by the MHRA for the whole of the United Kingdomįollowing Brexit, the European government agency, the European Medicines Agency (EMA), will continue to regulate certain medicines for Northern Ireland.

PLGB – Medicine licensed by the MHRA for Great Britain only.

The following marketing authorisation codes are applicable for Great Britain and UK-wide licensed medicines: These agencies are the UK Medicines and Healthcare Products Regulatory Agency (MHRA) and the European Medicines Agency (EMA).Įmc hosts medicines information for medicines licensed for use in Great Britain (England, Scotland and Wales), as well as UK-wide licensed medicines (Great Britain and Northern Ireland).

#Compendium definition license#

emc has more than 14,000 documents, all of which have been checked and approved by either the UK or European government agencies which license medicines. The electronic medicines compendium (emc) contains up to date, easily accessible information about medicines licensed for use in the UK.