The active ingredient in a medicine that makes it work.

An adverse reaction or side effect is an unwanted or unintentional reaction that a person may have after taking a medicine.

Committees of experts appointed by the Minister for Health to advise the HPRA.

There are three advisory committees:
ACHM – Advisory Committee for Human Medicines,
ACVM – Advisory Committee for Veterinary Medicines,
ACMD - Advisory Committee for Medical Devices.

An event which poses a risk to the health and safety of a patient or user of a medical device, or a case of diagnostic equipment not working correctly.

A substance or a combination of substances for treating or preventing disease in animals. Animal remedies are also known as veterinary medicinal products.

A report sent to the HPRA each year by the sponsor of a clinical trial which gives details of all new safety information on the trial.

An authorisation is an approval. The HPRA grants authorisations to companies to sell (or market) their medicines and to manufacture or distribute them. It also gives authorisations for establishments which deal with blood or tissues and cells for human use.

This benchmarking programme involves staff from different European medicines regulatory agencies visiting other agencies to conduct independent reviews of their management and their assessment, pharmacovigilance and inspection systems. The results of the assessments are used to help the agencies share best practices and highlight areas for improvement.

Any organisation involved in the collection, testing, processing, storage and distribution of blood and blood components. The HPRA grants blood establishments an authorisation for their activities.

Products which may be medicines or may be foods, cosmetics or medical devices depending on either the ingredients or the claims made for the product or both. A claim will usually relate to the intended benefit of using the product.

A body which has the authority to act on behalf of the government to ensure that legislation is implemented and followed. The HPRA is the Competent Authority for human and veterinary medicines, medical devices, cosmetic products, blood and blood components, tissues and cells.

A symbol on a medical device and its packaging which indicates that it meets the basic requirements for safety and effectiveness under European law.

A procedure used by pharmaceutical companies to obtain an authorisation for a medicine which allows them to sell it in all EU countries. Under this procedure, companies submit one single application to the European Medicines Agency. The application is assessed by experts from two different EU countries (called the 'rapporteur' and 'co-rapporteur'). The authorisation is granted by the European Commission and allows the medicine to be marketed in all EU Member States.

Certificates of Free Sale are granted by the HPRA and other regulatory agencies in the EU. Companies must have these before they can export medicines or medical devices to countries outside the EU (‘third countries').

A scientific committee at the European Medicines Agency which gives opinions on the authorisation (or approval) of medicines for human use to the European Commission and develops guidelines on authorisation applications for pharmaceutical companies and medicines agencies.

An investigation to study the safety and/or performance of a medical device.

A committee of representatives of the medicines agencies in the EU and EEA which addresses procedural, regulatory and scientific issues relating to specific applications for marketing authorisations for medicines for human use (CMDh) or veterinary use (CMDv).

See Decentralised procedure.

A substance which has the potential for abuse and is controlled under the Misuse of Drugs Acts 1977 and 1984. Examples include cocaine and morphine.

See Centralised procedure.

Cosmetic products are intended to be applied to the skin or to body cavities for cleaning, perfuming, protecting and maintaining health. If they are applied into the eye or nasal cavity, they are regarded as medicinal products or medical devices.

A scientific committee at the European Medicines Agency which gives opinions on the authorisation of medicines for veterinary use to the European Commission and issues guidelines on authorisation applications to pharmaceutical companies and medicines agencies.

Department of Agriculture, Food and the Marine

A procedure used by pharmaceutical companies to obtain an authorisation to market a medicine in a number of EU countries. Under the decentralised procedure assessors in one EU country (the Reference Member State) assess the application on behalf of other EU countries (the Concerned Member States). All the countries involved agree to either authorise the medicine or to refuse to authorise it.

Department of Health

The file of information on the quality, safety and efficacy (or effectiveness) of a medicine, submitted by a company in their application for a marketing authorisation.

The importation from a country within the European Economic Area of a medicinal product which is identical in all respects (including identical packaging, labels and leaflets) to the product on the Irish market.

A European organisation involved in harmonisation and co-ordination of standardisation, regulation and quality control of medicines, blood transfusion, organ transplantation, pharmaceuticals and pharmaceutical care.

Member States of the EU together with Iceland, Liechtenstein and Norway.

An agency of the European Union with headquarters in London. Its main responsibility is the protection and promotion of public and animal health, through the evaluation and supervision of medicines for human and veterinary use. The HPRA is represented on the scientific committees which conduct the main scientific work of the EMA.

Studies of populations which attempt to identify the cause or causes of particular health effects or outcomes.

The central European database created to capture data relating to medical devices that are registered with competent authorities across the EU, typically Class I and in-vitro diagnostic devices. It also includes national Competent Authority reports associated with vigilance information.

A database of information on the content, commencement and termination of all clinical trials in the European Union (from 1 May 2004 onwards). It was established in accordance with Directive 2001/20/EC, and is managed by the European Medicines Agency.

The central database of information on all medicinal products for human or veterinary use that have been authorised in the EU. It currently holds data on medicines authorised by the European Commission and will be extended over time to all nationally-authorised products. The database is accessible to the public at http://eudrapharm.eu.

The data management system for reporting and evaluating suspected adverse reactions experienced by patients during clinical trials and from use of medicines once approved.

Unauthorised products which are supplied to the order of registered doctors or dentists for use by their individual patients under their direct personal supervision.

A procedure for obtaining information from public bodies.

A set of internationally recognised ethical and scientific quality requirements for clinical trials involving humans.

A set of internationally recognised requirements or standards to ensure that products released for distribution are of the appropriate quality.

A generic medicine is a medicine which has the same active ingredient(s) as a brand name medicine and meets the same standards of safety, quality and effectiveness as the branded medicine.

A set of internationally recognised requirements or standards which ensure the laboratory work is of high quality.

A set of internationally recognised requirements or standards which ensures that products are consistently produced and controlled to the appropriate quality for their intended use.

The process of monitoring the safety of blood products and components. In Ireland this is the remit of the National Haemovigilance Office.

The movement towards global standardisation of the regulation of medicines or medical devices.

For example, a doctor, dentist, nurse or pharmacist.

Healthcare products regulated by the HPRA include medicines for human or veterinary use, medical devices for human use, blood products, tissues and cells, controlled drugs and cosmetics.

A network of the heads of medicines agencies throughout the EU.

A scientific committee at the European Medicines Agency which deals with herbal medicines.

A reference book of medicines available in Ireland used by doctors, nurses and pharmacists.

An implantable medical device is one that is placed inside a patient’s body during a medical procedure, such as surgery, and is intended to stay there after the procedure. Examples include cardiac pacemakers and hip implants.

A medical device which is used to diagnose illness such as test kits for blood glucose.

Another term for ‘authorisation’.

This allows the marketing authorisation holder to sell the medicine.

The company that holds the marketing authorisation for a medicine and is entitled to sell/market it.

An EU meeting dealing with medical devices that is attended by delegates from each EU Member State.

European legislation relating to medical devices.

A medical device is a healthcare product or piece of equipment that a person uses for a medical purpose. It is not a medicine or drug. Examples of medical devices include wheelchairs, contact lenses and pregnancy test kits.

A product which contains a substance to treat or prevent disease in humans. Also known as a medicine or drug.

One of the countries in the European Union i.e. Austria, Belgium, Bulgaria, Cyprus, the Czech Republic, Denmark, Estonia, Finland, France, Germany, Greece, Hungary, Ireland, Italy, Latvia, Lithuania, Luxembourg, Malta, the Netherlands, Poland, Portugal, Romania, Slovakia, Slovenia, Spain, Sweden or the United Kingdom. Iceland, Liechtenstein and Norway are not full Member States but are fully involved in European procedures.

A pharmaceutical prescribing reference guide which lists medicines available in Ireland.

A procedure used by pharmaceutical companies to extend a marketing authorisation held in one Member State to other Member States.

Method of communication between national Competent Authorities on medical device vigilance issues.

An application for a marketing authorisation made directly to the HPRA. This procedure can only be used to apply for a marketing authorisation for the Irish market. The authorisation cannot be used in any other Member State.

An organisation that has been accredited (or approved) by a Member State to assess the compliance of medical device with EU standards.

 

This is when a medicine is used to treat a condition which is not approved and listed in the summary of product characteristics.

The Official Medicines Control Laboratories support the regulatory authorities and the national inspection services in controlling the quality of medicinal products on the market by independent re-testing based on legal requirements.

A medicine for a rare disease.

These medicines are available without a prescription and are usually for milder conditions and short-term use. While some of these products are available on general sale in retail outlets, others can only be purchased in pharmacies.

A number which indicates that a medicine for human use has been approved and has a marketing authorisation which allows it to be sold in Ireland. Each medicine has a unique number.

The importation of a product authorised in another EEA member state, which is essentially similar to a product already authorised in Ireland.

Patients and consumers include those who take medicines or use medical devices, their carers, and users of other healthcare products.

Cumulative reports of all adverse reactions to medicinal products received in defined reporting periods

All activities relating to monitoring the safety of medicines on the market.

Leaflet supplied with a medicine, containing information for the patient (also known as package leaflet).

Medicines which require medical supervision and available only with a doctor’s or dentist’s prescription and dispensed through pharmacies.

A substance that may be used as a starting material for the manufacture of a controlled drug.

A product recall occurs when a medicine or medical device is removed from the market because of a quality defect or safety issue.

The person in a manufacturing site who is authorised to release medicines onto the market.

The person in the marketing authorisation holder company who has overall responsibility for monitoring the safety of medicines on the market.

A defect in a product which may affect its safety or effectiveness.

A person who is responsible for a regulatory activity such as assessing an application for marketing authorisation in the centralised procedure or drafting a guideline or legal instrument. A rapporteurship is the activity which the rapporteur carries out.

The HPRA’s online system for viewing marketing authorisation applications for medicines.

The EU country which takes the lead in assessing applications for marketing authorisation on behalf of other countries in the mutual-recognition or decentralised procedure.

A format for delivering regularly-changing web content.

An adverse reaction to a medicine (or medical device) which: (a) results in death, in disability or in a birth defect, (b) is life-threatening, or (c) requires a stay in hospital.

A drug that should not be taken during pregnancy as it may harm the developing foetus.

A manufacturer located outside of the European Economic Area (EEA).

An amendment of an existing marketing authorisation which must be approved by the regulatory authority. Variations can be minor (Type IA or Type IB) or major (Type II).

A product containing a substance or a combination of substances for treating or preventing disease in animals. Veterinary medicinal products are also known as animal remedies.

A marketing authorisation for a veterinary medicine.