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A referral is a procedure used to resolve disagreements and address concerns.
In a referral, the European Medicines Agency is requested to conduct a scientific assessment of a particular medicine or class of medicines on behalf of the European Union (EU). The medicine, or the class or medicines, is ‘referred’ to the Committee for Medicinal Products for Human Use (CHMP), so that the Committee can make a recommendation for a harmonised position across the EU.
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. 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 EU.
| From Directive 2001/83/EC | |
|---|---|
| Article 29(4) | This type of referral is triggered when there is a disagreement between Member States regarding a medicine being evaluated during a ‘mutual recognition’ or ‘decentralised’ procedure, on the grounds of potential serious risk to public health. |
| Article 30 | This type of referral is triggered when Member States have adopted different decisions over the years for some medicines (e.g. different indications, contraindications or posology) and there is a need to harmonise across the EU. |
| Article 31 | This type of referral is triggered when the interest of the Community is involved, following concerns relating to the safety or efficacy of a medicine or a class of medicines. |
| Article 36 | This type of referral applies for a marketing authorisation that has been granted via the mutual recognition or decentralised procedure. It is triggered when a MS considers that an action (variation, suspension or withdrawal) is needed on the grounds of the need to protect public health. |
| Article 107 | This type of procedure is triggered when a Member State varies, suspends or revokes the marketing authorisation for a medicine in its territory because of a safety issue. It informs the CHMP so that a EU-wide decision can be reached. |
| From Regulation (EC) 1084/2003 | |
|---|---|
| Article 5(11) | This type of referral is triggered for a medicine that has been authorised by mutual recognition or via the decentralised procedure when there is disagreement between Member States on a variation (type IB). |
| Article 6(12) and 6(13) | This type of referral is triggered for a medicine that has been authorised by mutual recognition or via the decentralised procedure when there is disagreement between Member States on a variation (type II). |
| From Regulation (EC) 726/2004 | |
|---|---|
| Article 20 | This type of procedure is triggered for medicines that have been authorised via the centralised procedure. The outcome of these procedures is published with the European public assessment report for the medicine. |
| From Regulation (EC) 1901/2006 | |
|---|---|
| Article 29 (paediatric) | This type of procedure may be triggered by a marketing authorisation holder when applying for a new indication, new pharmaceutical form or new route of administration for use in the paediatric population for a product authorised under Directive 2001/83/EC. |
| From Regulation (EC) 1234/2008 | |
|---|---|
| Article 13 | This type of referral is triggered for a medicine that has been authorised by mutual recognition or via the decentralised procedure when there is disagreement between Member States on a variation (type II). |
How does the European Medicines Agency inform about referrals?
The Agency announces the start of referral procedures in the CHMP meeting highlights when the referrals are officially started. In the same way, the Agency announces their conclusion in the CHMP meeting highlights of the meeting when the opinion is given. This announcement is accompanied by a question-and-answer document giving more information, in public-friendly language.
Once the European Commission has issued its decision on the referral, more information is published:
- a list of all products affected by the referral;
- the conclusions of the Committee;
- if relevant, the recommendations from the Committee for the prescribing information for the medicine, and any conditions that can be applied to the marketing authorisation.
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