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Positions & Policies

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 the Regulation (EC) No 141/2000 on Orphan Medicinal Products which promotes research and development of medicines to treat rare diseases.

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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 guide, low prevalence is taken as prevalence of less than 5 per 10,000 in the Community.

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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 Consumer Policy, John Dalli, as an important step forward for all patients in European countries.

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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 been authorized by regulatory bodies such as the European Medicines Agency (EMA), or the value of authorized drugs in cases ...

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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 that of clinical trial participants. Therefore, drugs continue to be monitored once they are put on the market so as ...

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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 concerning the “Report on current practices with regard to the provision of information to patients on medicinal products” to the ...

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Blood safety & donation

Regular blood transfusions have been a central aspect of the treatment of thalassaemia since the 1960s. As blood transfusion is a lifelong treatment for thalassaemia, the Thalassaemia International Federation (TIF) advocates for the promotion and development of policies by national health authorities for ensuring the safety and adequacy of blood ...

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