Glossary for P
PA – Product Authorisation
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
Patients and consumers include those who take medicines or use medical devices, their carers, and users of other healthcare products.
Periodic safety update reports
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.
PIL – Patient information leaflet
Leaflet supplied with a medicine, containing information for the patient (also known as package leaflet).
POM – Prescription Only Medicine
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.
PSUR – Periodic safety update report
A report containing the records of suspected adverse reactions to a medicine submitted to the Competent Authority at agreed points in time following authorisation of the medicine.