European Medicines Agency - Human Medicines - Referrals - Article 31 - 'community interest' referrals

Human Medicines - Referrals
List of Referrals - Article 31 - 'community interest' referrals
Background

Article 31 of Directive 2001/83/EC as amended states that ‘the Member States or the Commission or the applicant or the marketing authorisation holder shall, in specific cases where the interests of the Community are involved, refer the matter to the Committee … before any decision is reached on a request for a marketing authorisation or on the suspension or revocation of an authorisation …in particular to take account of the information collected in accordance with Title IX [pharmacovigilance]’.

This referral can also be triggered for a range of medicinal products or a therapeutic class.

Prior to 2001, this type of referral was known as an article 12 referral (referring to article 12 of Council Directive 75/319/EEC as amended).

At the end of the referral, the CHMP opinion may contain a recommendation for some changes to the prescribing information (such as the SPC wording). It can also contain some conditions to the marketing authorisation, to ensure that the safety of the medicine(s) is monitored appropriately. It can also recommend a suspension or withdrawal of the authorisation.

Medicinal products

Date of publication
INN/common name (s)
Example(s) of approved name(s)

20/11/2008 etoricoxib - Arcoxia
24/07/2008 norfloxacin - Norfloxacin
26/06/2008 ergot derived dopamine agonists ***
23/01/2008 piroxicam - Feldene
07/01/2008 veralipride - Agreal
03/10/2007 bicalutamide 150 mg - tablets Casodex
29/08/2006 pimecrolimus topical formulations - Elidel
06/12/2005 celecoxib - Celebrex
06/12/2005 etoricoxib - Arcoxia
06/12/2005 lumiracoxib - Prexige
21/11/2005 paroxetine - Seroxat
03/11/2005 SSRI/SNRI **
14/07/2004 loratadine and pseudoephedrine - Clarinaze
14/07/2004 loratadine - Clarityn
09/06/2004 celecoxib - Celebrex
09/06/2004 etoricoxib - Arcoxia
09/06/2004 rofecoxib - Vioxx
13/05/2004 nimesulide - Aulin, - Nimed
01/03/2004 calcitonins - Calcitonin
13/12/2002 sibutramine - Reductil
29/10/2002 cisapride - Propulsid

Article 12

12/10/1998 vigabatrin - Sabril
21/01/1998 terfenadine - Triludan, - Teldane
22/09/1997 chlormezanone - Trancopal
09/12/1996 anorectics *
26/06/1996 naftidrofuryl - Praxilene
06/05/1996 sparfloxacin - Zagam


* amfepramome, clobenzorex, dexfenfluramine, fenbutrazate, fenfluramine, fenproporex, mazindol, mefenorex, norpseudoephedrine, phenmetrazine, phendimetrazine, phentermine and propylhexedrine.

** Selective serotonin Re-uptake Inhibitors and Serotonin-Norepinephrine Re-uptake Inhibitors (atomoxetine, citalopram, escitalopram, fluoxetine, fluvoxamine, mianserine, milnacipran, mirtazapine, paroxetine, reboxetine, sertraline and venlafaxine).

*** Bromocriptine, cabergoline, dihydroergocryptine, lisuride and pergolide

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European Medicines Agency - Human Medicines - Referrals - Article 31 - 'community interest' referrals