viernes, 28 de mayo de 2010

European Medicines Agency - Human Medicines - Referrals

Human Medicines - Referrals
What is a referral?
A referral is a procedure used to resolve disagreements and address concerns. In a referral, the European Medicines Agency is requested to conduct, on behalf of the European Community, a scientific assessment of a particular medicine or class of medicines. The medicine, or the class or medicines, is ‘referred’ to the CHMP, so that the Committee can make a recommendation for a harmonised position across the European Union.

There are a number of reasons why a referral may be started, ranging from concerns over the safety of a class of medicine to disagreements among Member States on the use of the medicine (see below for more details of all types of referral procedures). Referrals can be started by the European Commission, any Member State or by the company who makes the medicine.

At the end of the referral, the Committee makes a recommendation, and the European Commission issues a decision to all Member States reflecting the measures to take to implement the CHMP recommendation.

Types of referrals
All referrals are described in the legislative texts that govern how medicines are authorised and monitored in the European Union.

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European Medicines Agency - Human Medicines - Referrals

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