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
 
 
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