Links to national authority websites

Public information on compassionate use programmes will be available soon. See below for who to contact in your national authority

France probably has the most elaborated scheme for compassionate use programmes, called A.T.U. (Temporary Use Authorisation).

The A.T.U. is a legal tool, which was implemented in 1994 (in fact even earlier). Between 1994-2011, more than 1000 medicinal productswere authorised in France, of which 230 were subject to ATU.

On average, ATU permits the product to be available 10-12 months before a marketing authorisation is granted. The main therapeutic areas where ATUs are granted are oncology-haematology, central nervous system, infectious diseases including AIDS, and metabolism (rare diseases).

For named-patient compassionate use (nominative ATUs), 25 000 ATU were granted in 2011 (initial and renewal) and 460 refused. This represented 18 000 patients (30% children).

For cohort ATUs, more than 130 active substances have been authorised for a Compassionate Use Programmesince 1994. For rare diseases in particular, 70% of the authorised Orphan Medicinal Products were available via an ATU before the marketing authorisation, on average 34 months before the marketing authorisation.

EEA Member State	Website	Where to find information on CUPs
Austria Austrian Medicines and Medical Devices Agency	http://www.basg.at	http://www.basg.at Contact: compassionate-use@ages.at
Belgium Federal Agency for Medicines and Health Products	www.fagg-afmps.be	http://www.fagg-afmps.be
Bulgaria Bulgarian Drug Agency	www.bda.bg	Unknown
Croatia	-	Unknown
Cyprus Ministry of Health Pharmaceutical Services	http://www.moh.gov.cy	Unknown
Czech Republic State Institute for Drug Control	http://www.sukl.eu	Unknown
Denmark Danish Medicines Agency	www.dkma.dk	http://laegemiddelstyrelsen.dk
Estonia State Agency of Medicines	http://ravimiamet.ee	Unknown
Finland Finnish Medicines Agency	http://www.fimea.fi	http://www.fimea.fi
France French National Agency for Medicines and Health Products Safety	www.ansm.sante.fr	http://ansm.sante.fr Also contact: atu@afssaps.sante.fr
Germany Paul Ehrlich Institut	http://www.pei.de	http://www.pei.de Also contact: Ct@pei.de
Greece National Organization for Medicines	www.eof.gr	http://www.eof.gr
Hungary National Institute of Pharmacy	http://www.ogyi.hu	Unknown
Iceland Icelandic Medicines Agency	www.imca.is	Unknown
Ireland Irish Medicines Board	http://www.imb.ie	Ask for Department of Exempt Products Customer Service Unit Telephone: +353-1-6764971 email: customerservice@imb.ie
Italy Agenzia Italiana del Farmaco	www.agenziafarmaco.it	Unknown
Latvia State Agency of Medicines of Latvia	www.zva.gov.lv	Unknown
Lithuania State Medicines Control Agency	www.vvkt.lt	Unknown
Luxembourg Direction de la Santé Villa Louvigny Division de la Pharmacie et des Medicaments	www.ms.public.lu/fr/	Unknown
Malta Medicines Authority	medicinesauthority.gov.mt	Unknown
Netherlands Medicines Evaluation Board	www.cbg-meb.nl	http://www.cbg-meb.nl
Norway The Norwegian Medicines Agency	legemiddelverket.no	http://www.legemiddelverket.no also contact: Department of Preclinical and clinical trials cloth@legemiddelverket.no Tel. 22 89 77 00
Poland Office for Registration of Medicinal Products, Medical Devices and Biocidal Products	bip.urpl.gov.pl	Unknown
Portugal Infarmed	www.infarmed.pt	Unknown
Romania National Medicines Agency	anm.ro/en/home.html	Unknown
Slovenia Javna agencija Republike Slovenije za zdravila in medicinske pripomočke	http://www.jazmp.si/	http://www.jazmp.si
Slovakia State Institute for Drug Control	http://www.sukl.sk/	e-mail: office@health.gov.sk
Spain Agencia Española de Medicamentos y Productos	www.agemed.es	http://www.aemps.gob.es
Suede Medical Products Agency	www.lakemedelsverket.se	http://www.lakemedelsverket.se
United-Kingdom Autorità Regolamentare per il Farmaco e i Prodotti Sanitari	www.mhra.gov.uk	http://www.mhra.gov.uk

Updated 07/06/2013

For rare diseases in France, 70% of the authorised Orphan Medicinal Products were available via an ATU before the marketing authorisation, on average 34 months before the marketing authorisation).

United-Kingdom Autorità Regolamentare per il Farmaco e i Prodotti Sanitari	www.agemed.es	http://www.mhra.gov.uk

Page created: 30/10/2013
Page last updated: 30/09/2016

16/04/2014

Improve Compassionate Use Programmes to ensure patients’ early access...

10/05/2017

Find assistance

Help Lines in Europe

Contact us

This information is provided by François Houÿez, Treatment Information and Access Director, Health Policy Advisor, EURORDIS, and the Drug Information, Transparency and Access task force.