Counterfeit medicines also known as falsified medicines are medicines that have inadequate documentation relating to their identity (e.g. what they contain), history (where they have come from) or source (where manufactured). These products often contain sub-standard or falsified ingredients, or no ingredients or ingredients, including active substances, in the wrong dosage thus posing a threat to a patient’s health.
Precedent indicates that falsified medicinal products usually reach patients via a number of illegal channels such as online pharmacies. However, they can sometimes enter the legal supply chain via registered pharmaceutical distributors, wholesalers or pharmacies.
Measures to prevent Counterfeit medicines entering the legal supply chain
In July 2011 the European Commission introduced the EU Falsified Medicines Directive, aimed at preventing the entry of counterfeit medicines into the legal supply chain. The primary objective is patient safety.
In Ireland, the Irish Medicines Verification Organisation (IMVO) was established as the body responsible for the local implementation of some of these EU requirements. These requirements include the mandatory placing of safety features consisting of a unique identifier and an anti-tampering device on the packaging of medicines which can be scanned or inspected by your pharmacist to validate the authenticity of the medicine. In Ireland, this verification system is up and running.
Registered doctors may prescribe medicines on-line after a consultation in Ireland however, the supply of medicines via on-line pharmacies is prohibited. This is to ensure that a pharmacist can physically inspect any medication you have been prescribed before you receive it.
Other Safeguards to ensure Safety of Medicines
Under the Falsified Medicines Directive there are a number of other measures to ensure that medicines are authentic, traceable and of safe quality. Manufacturers of medicinal products must comply with the principles of good manufacturing practices, and must use only active substances which have been manufactured in accordance with such practices. These practices are overseen by that countries medicines and health product authority. Importers of medicines and manufacturers of medicinal products in the EU must check that all the relevant documentation evidencing compliance with good manufacturing practice is validated.
The Directive in essence sets out a system whereby the identification and the authentication of medicinal products is guaranteed by an end-to-end verification process of all medicinal products bearing the safety features, supplemented by the verification by wholesalers of certain medicinal products at higher risk of falsification.
These new measures are designed to prevent falsified medicines from entering the legal supply chain and ultimately create a welcoming reliability for healthcare professionals and patients alike.
The information on this website is intended for Republic of Ireland residents only
Date of Preparation: October 2020