Definitions

Provides information on terms such as 'safety alerts' and 'black triangles'

What Is an SmPC?
SmPC stands for Summary of Product Characteristics. An SmPC is used by healthcare professionals - such as doctors, nurses, and pharmacists - and...
Thu, 18 May, 2023 at 4:11 PM
What Is a PIL?
  PIL stands for Patient Information Leaflet - also known as a Package Leaflet (PL). It is the leaflet that is included in the pack with a medi...
Thu, 18 May, 2023 at 4:20 PM
What Are Risk Minimisation Materials (RMMs)?
For some medicines, the pharmaceutical company has a regulatory obligation to produce information for healthcare professionals and/or patients that will m...
Thu, 18 May, 2023 at 4:32 PM
What Does the Black Triangle Mean?
Some Summaries of Product Characteristics (SmPCs) and Patient Information Leaflets (PILs) have an inverted black triangle symbol  displayed at the top ...
Thu, 18 May, 2023 at 4:34 PM
What Is a Discontinued Product?
Discontinued products are medicines that are no longer marketed   Pharmaceutical companies will often leave their SmPCs and PILs for discontinued medic...
Thu, 18 May, 2023 at 4:39 PM
What Is a Side Effect?
Side effects, also known as adverse drug reactions (ADRs), are unwanted symptoms that are linked with taking a medicine. They can range from mild - fo...
Thu, 18 May, 2023 at 4:41 PM
What Are Safety Alerts?
Occasionally, the medicines regulators - European Medicines Agency (EMA) or Medicines and Healthcare Products Regulatory Authority (MHRA) - issue specific ...
Thu, 18 May, 2023 at 4:42 PM