Positions & Policies
Orphan Drugs
August 4, 2017
Orphan Drugs
An orphan medicinal product is one that is intended for the diagnosis, prevention or treatment of a condition that affects not more than 5 in 10 000 persons, according to…
Rare Diseases
August 4, 2017
Rare Diseases
Rare diseases, including those of genetic origin, are life-threatening or chronically debilitating diseases which are of such low prevalence that special combined efforts are needed to address them. As a…
Cross Border Healthcare
August 4, 2017
Cross Border Healthcare
On 19 January 2011, the European Parliament voted in favour of the EU Directive on cross-border healthcare, a move hailed on that same day by European Commissioner for Health and…
Clinical Trials
August 4, 2017
Clinical Trials
A clinical trial in the European Union is defined by Directive 2001/20/EC, as a clinical study that aims to investigate the therapeutic effect(s) of medicinal products that have not yet…
Pharmacovigilance
August 4, 2017
Pharmacovigilance
It is a well known fact that little is truly known about any medicinal product prior to its entry into the market and interaction with a more diverse population than…
Information to patients
August 4, 2017
Information to patients
The necessity to amend the Directive on the Information to Patients on Prescribed Medicinal Products (2001/83/EC) arose after the submission of the Commission, on 20 December 2007, of a Communication…
Blood safety & donation
August 4, 2017
Blood safety & donation
Visual taken from WHO, World Blood Donor Day 2017 Regular blood transfusions have been a central aspect of the treatment of thalassaemia since the 1960s. As blood transfusion is a lifelong…