Sign up now for ease of access to The Medical Independent, Ireland’s most frequently published medical newspaper, delivering award-winning news and investigative reporting.

  • receive the eCopy two days prior to the printed edition.
  • can partake in our online MCQs.
  • can enter our online sports quiz.


Medicalindependent.ie is Ireland's only investigative medical news website for doctors, healthcare professionals and anyone with an interest in health issues.

Established in 2010, along with its sister publication The Medical Independent, our stated aim is to investigate and analyse the major issues affecting healthcare and the medical profession in Ireland. The Medical Independent has won a number of awards for its investigative journalism, and its stories are frequently picked up by national digital, broadcast and print media. The Medical Independent is published by GreenCross Publishing.

Address: Top Floor, 111 Rathmines Road Lr, Dublin 6

Tel: 353 (01) 441 0024

GreenCross Publishing is owned by Graham Cooke.

HSE prepares for Falsified Medicines Directive

By Mindo - 05th Dec 2018 | 16 views

The directive aims to protect the pharmaceutical supply chain from counterfeit medicines and introduces new EU-wide rules to provide for greater regulation of the supply chain.

From 9 February 2019, prescription medicines sold in the EU will need to carry a unique identifier (UI) and anti-tampering device (ATD).

All healthcare institutions and hospitals must be ready to “decommission” from this date.

The HSE is currently seeking a provider to help it adhere to the new rules and implement a “decommissioning solution to enable a healthcare institution to verify the authenticity of each pack of prescription medicines delivered prior to dispensing to patients”. 

“It is envisaged that the level of usage of the Decommissioning Solution may start off low in February 2019 and rise during the remainder of the year, in line with the number of FMD-compliant packs entering the supply chain,” according to tender documents released by the HSE.

“In order to secure the legal supply chain of medicinal products, the Falsified Medicines Directive 2011/62/EU (FMD) and Commission Delegated Regulation (EU) 2016/161 (DR) have introduced a new end-to-end verification system for medicinal products.  The end-to-end verification is a medicines authentication system including mandatory safety features and a repository that stores information on each individual pack.” 

Irish hospitals will need to verify the safety features on prescription medicines and decommission the unique identifier before supply to the patient, according to the HSE.                

“Considering that hospitals receive large volumes of medicinal products which are administered to the patient at ward level, decommissioning may take place at any time the medicine is in the physical possession of the hospital, as long as no sale takes place between delivery and supply,” stated the Executive.

Leave a Reply

Latest
Latest Issue
medical news
The Medical Independent 19th May 2022

You need to be logged in to access this content. Please login or sign up using the links below.

Most Read