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National Competent Authority for Drugs

Austrian Agency for Health and Food Safety
(Österreichische Agentur für Gesundheit und Ernährungssicherheit GmbH)
Spargelfeldstraße 191
1220 Wien
Tel: +43 5 0555-0
Fax: +43 5 0555-22019
Web: www.ages.at

National Competent Authorites for Tissues and Cells

Bundesamt für Sicherheit im Gesundheitswesen (BASG)
(Austrian Federal Office for Safety in Health Care)
Traisengasse 5
1200 Vienna
Austria

National Academic GMP Expert

Institute: Medizinische Universität Wien
Name: Prof. Hildegard Greinix
email: hildegard.greinix[at]meduniwien.ac.at
Tel: +43-1-404-005-706

National Academic GMP Expert

Institute: Medizinische Universität Wien
Name: Prof. Nina Worel
email: nina.worel[at]meduniwien.ac.at
Tel: +43-1-404-005-308

National Academic GMP Expert

Institute: Medizinische Universität Innsbruck
Name: Dr. Brigitte Kircher
email: brigitte.kircher[at]uki.at
Tel: +43-512-504-24003

Hospital exemption for ATMPs

How many ATMPs legally on the market: 3
Prepared on a routine basis: not yet assessed
Which fall under the hospital exemption: framework currently in development
Criteria applied for HE: manufacturing license needed

Please Note: This content is based upon information provided by the Member States of the European Union.
The AGORA consortium cannot provide any guarantee as to the accuracy thereof.

National Competent Authority for Drugs

Federal Agency for Medicines and Health Products
Eurostation building, block 2
Place Victor Horta, 40/ 40
1060 Brussels, Belgium
Tel: +32 2 524 7111
email: info.medicines[at]fagg-afmps.be
Web: www.fagg-afmps.be

National Competent Authorites for Tissues and Cells

National Academic GMP Expert

Institute: Université Libre de Bruxelles (ULB)
Name: Alain Delforge
email: alain_delforge[at]ulb.ac.be
Tel: +32-2 541-3725

Hospital exemption for ATMPs

How many ATMPs legally on the market:
Prepared on a routine basis: 16 cell and tissue banks have received temporary authorization until further examination of their activities has been performed (on the basis of a dossier), with the purpose to identify products that would fall under the HE Clause
Which fall under the hospital exemption:
Criteria applied for HE: more specific requirements are planned to be developed based on the examination mentioned above

Please Note: This content is based upon information provided by the Member States of the European Union.
The AGORA consortium cannot provide any guarantee as to the accuracy thereof.

National Competent Authority for Drugs

Bulgarian Drug Agency
8 Damyan Gruev Str.
Sofia 1303, Bulgaria
Tel: +359 2 890 35 55
Fax: +359 2 890 34 34
email: bda[at]bda.bg
Web: www.bda.bg

National Competent Authorites for Tissues and Cells

Executive Agency for Transplantation (EAT)
112 Bratia Miladinovi Str.
1202 Sofia, Bulgaria
Tel: +359 2 813 50 10
Fax:: +359 2 931 61 51
email: iat[at]bgtransplant.bg

National Academic GMP Expert

Name: Lubomir Arseniev
email: arseniev.lubomir[at]mh-hannover.de
Tel: +49-511-532-7987

Please Note: This content is based upon information provided by the Member States of the European Union.
The AGORA consortium cannot provide any guarantee as to the accuracy thereof.

National Competent Authority for Drugs

Agency for medical products and medical devices of Croatia
Ksaverska cesta 4
10 000 Zagreb, Croatia
Tel: +385 1 4884 100
Fax: +385 1 4884 110
email: halmed[at]halmed.hr
Web: www.almp.hr

National Competent Authorites for Tissues and Cells

Hospital exemption for ATMPs

How many ATMPs legally on the market: 0 (application for ChondroCelect received)
Prepared on a routine basis:
Which fall under the hospital exemption:
Criteria applied for HE:

Please Note: This content is based upon information provided by the Member States of the European Union.
The AGORA consortium cannot provide any guarantee as to the accuracy thereof.

National Competent Authority for Drugs

Ministry of Health-Pharmaceutical Services
7 Larnacos Avenue
1475 Nicosia, Cyprus
Web: www.moh.gov.cy

National Competent Authorites for Tissues and Cells

Hospital exemption for ATMPs

How many ATMPs legally on the market: 0
Prepared on a routine basis:
Which fall under the hospital exemption:
Criteria applied for HE:

Please Note: This content is based upon information provided by the Member States of the European Union.
The AGORA consortium cannot provide any guarantee as to the accuracy thereof.

National Competent Authority for Drugs

State Institute for Drug Control
Srobárova 48
100 41 Praha 10; Czech Republic
Tel: +420 272 185 333
Fax: +420 272 185 756
email: infs[at]sukl.cz
Web: www.sukl.cz

National Competent Authorites for Tissues and Cells

Hospital exemption for ATMPs

How many ATMPs legally on the market: GTMPs: 0; CBMPs: 3 in clinical trials; TEPs: 2 (autologous chondrocytes)
Prepared on a routine basis:
Which fall under the hospital exemption: 1 (extracorporeal phototherapy in GvHD), under classification
Criteria applied for HE: Criteria applied for HE: patient-specific (tailored for concrete patient); overall numbers of the particular product prepared; regularity/ frequency of production, and the time period over which the preparation of that product has been established; progression of the rate of manufacturing

Please Note: This content is based upon information provided by the Member States of the European Union.
The AGORA consortium cannot provide any guarantee as to the accuracy thereof.

National Competent Authority for Drugs

Danish Health and Medicines Authority
Axel Heides Gade 1
2300 Copenhagen S, Denmark
Tel: +45 7222 7400
email: sst[at]sst.dk
Web: www.laegemiddelstyrelsen.dk

National Competent Authorites for Tissues and Cells

Danish Health and Medicines Authority
Axel Heides Gade 1
2300 Copenhagen S, Denmark
Tel: +45 7222 7400
email: sst[at]sst.dk
Web: www.laegemiddelstyrelsen.dk

National Academic GMP Expert

Institute: Copenhagen University Hospital, Rigshospitalet, Department of Clinical Immunology
Name: Dr. Anne Fischer-Nielsen,
email: anne.fischer-nielsen@rh.regionh.dk

Hospital exemption for ATMPs

How many ATMPs legally on the market: 1 (Genzymes MACI); MAA expected
Prepared on a routine basis:
Which fall under the hospital exemption: 1 (Genzymes MACI); MAA expected
Criteria applied for HE:

Please Note: This content is based upon information provided by the Member States of the European Union.
The AGORA consortium cannot provide any guarantee as to the accuracy thereof.

National Competent Authority for Drugs

State Agency of Medicines
1 Nooruse Street
50411 Tartu, Estonia
Tel: +372 737 41 40
Fax: +372 737 41 42
email: inf[at]ravimiamet.ee
Web: www.ravimiamet.ee

National Competent Authorites for Tissues and Cells

Hospital exemption for ATMPs

How many ATMPs legally on the market:
Prepared on a routine basis:
Which fall under the hospital exemption:
Criteria applied for HE:

Please Note: This content is based upon information provided by the Member States of the European Union.
The AGORA consortium cannot provide any guarantee as to the accuracy thereof.

National Competent Authority for Drugs

Finnish Medicines Agency (Fimea)
P.O. Box 55
FI-00034 FIMEA, Finland
Tel: +358 29 522 3341
Fax: +358 9 4733 4339
Web: www.fimea.fi

National Competent Authorites for Tissues and Cells

National Academic GMP Expert

Institute: Finnish Red Cross Blood Service
Name: Johanna Nystedt
email: Johanna.Nystedt[at]veripalvelu.fi

Hospital exemption for ATMPs

How many ATMPs legally on the market: There are no ATM products legally on national markets in Finland. Marketing of the first centrally authorised product, ChondroCelect, is going to start soon in Finland. Still, it is known that Finnish university hospitals, orthopaedic clinics are using autologous chondrocyte preparations, for which patient biopsies are collected in Finland, exported for processing to a Swedish cell laboratory in Gothenburg and imported back to Finland for the clinical use. A license for tissue establishment is required for the procurement and exportation of the chondrocytes. The number of patients treated by using this optional method is approximately 10 to 20/year.
Prepared on a routine basis: Production of the chondrocyte preparations in Sweden are prepared using a routine process, but the cells and serum in each case are from different donors.
Which fall under the hospital exemption: None of the above-mentioned preparations are approved under the hospital exemption. Fimea has given a license for ATMP manufacturing under hospital exemption currently to one applicant producing an oncolytic virus product for cancer therapy and to one applicant producing six different tissue engineering products mainly for bone regeneration. Our interpretation is that the collaboration between the Finnish hospitals and the Swedish production site can continue until the end of the transitional period for TEPs (end of 2012) or until similar, centrally authorised product enters our markets.
Criteria applied for HE: The main criterion is an initial phase of drug development before entering into a clinical trial. The oncolytic viruses are used for single patients having different diagnosis of cancer and no option for conventional therapies. The treatment is offered individually in a private hospital under the responsibility of a treating physician. The tissue engineering products are prepared for individual patients in a non-routine basis for experimental treatment of facial defects. The aim of this experimental treatment is to find the most suitable combination of stem cells and biomaterial to be taken into the future clinical trial.

Please Note: This content is based upon information provided by the Member States of the European Union.
The AGORA consortium cannot provide any guarantee as to the accuracy thereof.

National Competent Authority for Drugs

National Agency for the Safety of Medicine and Health Products
(Agence nationale de sécurité du médicament et des produits de santé)
143-147 bd Anatole France
93285 Saint Denis cedex, France
Tel: +33 1 55 87 30 00
Web: www.ansm.sante.fr

National Competent Authorites for Tissues and Cells

National Academic GMP Expert

Institute: Stromalab
Name: PhD Luc Sensebé
email: luc.sensebe[at]efs.sante.fr
Tel: +33-561283760

National Academic GMP Expert

Institute: Institut Paoli-Calmettes
Name: Prof. Christian Chabannon
email: chabannonc[at]marseille.fnclcc.fr
Tel: + 33-4-91-22-34-41

Hospital exemption for ATMPs

How many ATMPs legally on the market: 1 (ChondroCelect)
Prepared on a routine basis: 1 (ChondroCelect)
Which fall under the hospital exemption: We are preparing the decree about the national legal framework describing the requirements to authorise the establishments which will prepare ATMP under HE and to authorize the MTI themselves. This decree will be probably published at the end of April. During the period, before the publication of this text, tissue banks have continued their activities for the products they are allowed to process at this moment.
Criteria applied for HE: The criteria applied to define ATMP under hospital exemption are those of the regulation. We have listed in the attached document all these criteria. We shall better know during the examination of the future authorization demands the exact nature of their activities and we could know if they fall under the exemption. We can already say that there are a number of ongoing as well as pending clinical trials using ATMPs in France. We think that very few of them will eventually result in application under article 28 of Reg 1394/2007.

Please Note: This content is based upon information provided by the Member States of the European Union.
The AGORA consortium cannot provide any guarantee as to the accuracy thereof.

National Competent Authority for Drugs

Paul Ehrlich Institute
Paul-Ehrlich-Straße 51-59
63225 Langen; Germany
Contact: Bettina Ziegele, M. A., Koordinatorin Innovationsbüro
Tel: +49 6103 77 1012, +49 6103 77 1033
Fax: +49 6103 77 1234
email: innovation[at]pei.de
Web: www.pei.de

National Competent Authorites for Tissues and Cells

National Academic GMP Experts

Institute: Klinikum rechts der Isar der technischen Universität München – TUMCells
Name: Prof. Dr. Martin Hildebrandt
email: Martin.Hildebrandt[at]mri.tum.de
Tel: +49-89-4140-7810

Institute: Klinikum der Universität Regensburg
Name: Dr. Andrea Hauser
email: Andrea.Hauser[at]klinik.uni-regensburg.de
Tel: +49-941-944-5100
Institute: Universitätsklinikum Würzburg
Name: Prof. Dr. Hermann Einsele
email: einsele_h[at]klinik.uni-wuerzburg.de
Tel: +49-931-201-70000

National Academic GMP Experts

Institute: Medizinische Hochschule Hannover
Name: Prof. Dr. Ulrike Köhl
email: koehl.ulrike[at]mh-hannover.de
Tel: +49-511-532-5718

Institute: Klinikum der Universität Regensburg
Name: Prof. Dr. Matthias Edinger
email: matthias.edinger[at]klinik.uni-regensburg.de
Tel: +49-941-944-5580

Institute: Universitätsklinikum Würzburg
Name: Prof. Matthias Eyrich,
email: Eyrich_M@kinderklinik.uni-wuerzburg.de

National Academic GMP Experts

Institute: Medizinische Hochschule Hannover
Name: Prof. Eva Mischak-Weissinger
email: mischak-weissinger.eva@mh-hannover.de
Tel: + 49 511 532 9518

Institute: Charité-Universitätsmedizin Berlin
Name: Dr. Joachim Kopp
email: joachim.kopp[at]charite.de

Hospital exemption for ATMPs

How many ATMPs legally on the market: Besides the product already mentioned which is centrally authorised (ChondroCelect, TiGenix), there are four ATMP legally on the market in Germany due to transitional provisions until December 30, 2012. These products are: Hyalograft C, CartiGro, MACI and CaReS. After the transitional period has expired on December 30, 2012, only ChondroCelect will be legally on the market in Germany. For two of the four products (MACI, Hyalograft) applications for central marketing authorisations are pending. If the procedures are successful, the products could be marketed in Germany as well after December 30, 2012. The procedures will be finished probably in the end of 2012 or the beginning of 2013.
Prepared on a routine basis: (ChondroCelect, TiGenix)
Which fall under the hospital exemption: 17 products which are legally on the market are all hospital exemptions.
Criteria applied for HE: In addition to the criteria laid down in Article 3 Nr. 7 of Directive 2001/83/EC (Article 28 of Regulation (EC) Nr. 1394/2007), in Germany for hospital exemptions an authorisation of the product by the higher federal authority is necessary.

Please Note: This content is based upon information provided by the Member States of the European Union.
The AGORA consortium cannot provide any guarantee as to the accuracy thereof.

National Competent Authority for Drugs

National Organization for Medicines
Messogion Avenue 284
15562 Athens
Greece
Tel: +30 213 2040 200
Fax: +30 210 6545 535
email: relation[at]eof.gr
Web: www.eof.gr

National Competent Authorites for Tissues and Cells

National Academic GMP Expert

Institute: Stem Health
Name: Eugenia Loannidi
email: eioannidi@stem-health.eu
Tel: + 30 6975883069

Hospital exemption for ATMPs

How many ATMPs legally on the market: No Advanced Therapy Medicinal Product has been approved in Greece. Concerning new ATMPs, there is one clinical study in process (genetically modified somatic cells).
Prepared on a routine basis:
Which fall under the hospital exemption:
Criteria applied for HE: The implementation of the hospital exemption status is still ongoing. Consequently, at this time point, we cannot specify the products that will fall under this category.

Please Note: This content is based upon information provided by the Member States of the European Union.
The AGORA consortium cannot provide any guarantee as to the accuracy thereof.

National Competent Authority for Drugs

National Institute of Pharmacy (GYEMSZI-OGYI)
Zrínyi utca 3, 1051 Budapest, Hungary
(Hungary Mailing address: 1372 Postafiók 450)
Tel: +36 1 88 69 -300
Fax: +36 1 88 69-460
email: ogyi@ogyi.hu
Web: www.ogyi.hu

National Competent Authorites for Tissues and Cells

Állami Népegészségügyi és Tisztiorvosi Szolgálat
ÁNTSZ (National Public Health and Medical Officer’s Service)
H-1097 Budapest
Albert Flórián út 2-6, Hungary
Web: www.antsz.hu/en

National Academic GMP Expert

Institute: Semmelweis University
Name: Balazs Sarkadi
email: sarkadi[at]biomembrane.hu
Tel: +36-1-3724316

Hospital exemption for ATMPs

How many ATMPs legally on the market:
Prepared on a routine basis:
Which fall under the hospital exemption: No “hospital exemption” requests have been received until now.
Criteria applied for HE: Their hospital exemption is defined at the level of an Act saying that the human medicines competent national authority has to licence the “manufacturing site” of such products in the in-patient institutions. This is valid since 1 January of 2011. There is an agreement on that some Good Manufacturing Practice rules, specially adjusted to this purpose (not the GMP ‘per se’!) will apply, but no details have been issued yet.

Please Note: This content is based upon information provided by the Member States of the European Union.
The AGORA consortium cannot provide any guarantee as to the accuracy thereof.

National Competent Authority for Drugs

Icelandic Medicines Agency
Vínlandsleið 14
113 Reykjavík, Iceland
Tel: +354 520 2100
Fax: +354 561 2170
email: ima[at]ima.is
Web: www.imca.is

National Competent Authorites for Tissues and Cells

Hospital exemption for ATMPs

How many ATMPs legally on the market: No Advanced Therapy Medicinal Products are legally on our market or used in hospitals in Iceland.
Prepared on a routine basis:
Which fall under the hospital exemption:
Criteria applied for HE:

Please Note: This content is based upon information provided by the Member States of the European Union.
The AGORA consortium cannot provide any guarantee as to the accuracy thereof.

National Competent Authority for Drugs

Irish Medicines Board
Vínlandsleið 14
Kevin O’Malley House
Earlsfort Terrace
Dublin 2, Ireland
Tel: +353 1 676 4971
Fax: +353 1 676 7836
email: imb[at]imb.ie
Web: www.imb.ie

National Competent Authorites for Tissues and Cells

Hospital exemption for ATMPs

How many ATMPs legally on the market: There is only one product under supplied hospital exemption (article 28) the MACI product which is currently going through the centralized procedure.
Prepared on a routine basis:
Which fall under the hospital exemption:
Criteria applied for HE: Manufacturer’s authorisation required-none yet issued. A guideline has been prepared for interested parties.

Please Note: This content is based upon information provided by the Member States of the European Union.
The AGORA consortium cannot provide any guarantee as to the accuracy thereof.

National Competent Authority for Drugs

Italian Medicines Agency (Agenzia Italiana del Farmaco – AIFA)
181 Via del Tritone
00187 Roma, Italy
Tel: +39 6 5978401
Fax: +39 06 59784312
Web: www.agenziafarmaco.it

National Competent Authorites for Tissues and Cells

Italian National Transplant Center (Centro Nazionale Trapianti -CNT)
Viale Reginal Elena 299
00161 Roma, Italy
Tel: + 39 649904040‐4041
Fax: + 39 649904101
Web: www.trapianti.salute.gov.it

National Academic GMP Expert

Institute: Ospedali Riuniti
Name: Dr. Martino Introna
email: mintrona[at]ospedaliriuniti.bergamo.it

National Academic GMP Expert

Institute: Bortolo Hospital
Name: Dr. Giuseppe Astori
email: astori[at]hemato.ven.it
Tel: +39 0444751721

Hospital exemption for ATMPs

How many ATMPs legally on the market: Three advanced therapy products have been granted the status of “legally on the market by the Italian Medicines Agency on November 25th, 2008. The three products are Hyalograft C autograft (cartilage), Hyalograft 3D autograft e Laserskin autograft (skin). The Applicant, Anika Therapeutics (former Fidia Advanced Biopolymers (FAB) ) is planning to submit a file for authorization only for Hyalograft C auto graft in March 2012, hence before December 2012 that is the deadline for tissue engineering products.
Prepared on a routine basis:
Which fall under the hospital exemption:
Criteria applied for HE: draft technical text available; the verification of legal aspects is currently in progress.

Please Note: This content is based upon information provided by the Member States of the European Union.
The AGORA consortium cannot provide any guarantee as to the accuracy thereof.

National Competent Authority for Drugs

Ministry of Health
Allée Marconi
2120 Luxembourg; Luxembourg
email: ministere-sante[at]ms.etat.lu
Web: www.ms.etat.lu

National Competent Authorites for Tissues and Cells

Hospital exemption for ATMPs

How many ATMPs legally on the market: 2 ATMPs have been centrally authorized, none is in use in Luxembourg
Prepared on a routine basis:
Which fall under the hospital exemption:
Criteria applied for HE:

Please Note: This content is based upon information provided by the Member States of the European Union.
The AGORA consortium cannot provide any guarantee as to the accuracy thereof.

National Competent Authority for Drugs

State Agency of Medicines
15 Jersikas Street
1003 Riga, Latvia
Tel: +371 7078424
Fax: +371 7078428
email: info[at]zva.gov.lv
Web: www.zva.gov.lv

National Competent Authorites for Tissues and Cells

Hospital exemption for ATMPs

How many ATMPs legally on the market: no such products on the market, therefore no use in hospitals of products that are prepared on a routine basis or fall under the hospital exemption.
Prepared on a routine basis:
Which fall under the hospital exemption:
Criteria applied for HE:

Please Note: This content is based upon information provided by the Member States of the European Union.
The AGORA consortium cannot provide any guarantee as to the accuracy thereof.

National Competent Authority for Drugs

Office of Health/ Department of Pharmaceuticals
Äulestr 512
9490 Vaduz; Liechtenstein
Web: www.llv.li

National Competent Authorites for Tissues and Cells

Hospital exemption for ATMPs

How many ATMPs legally on the market:
Prepared on a routine basis:
Which fall under the hospital exemption:
Criteria applied for HE:

Please Note: This content is based upon information provided by the Member States of the European Union.
The AGORA consortium cannot provide any guarantee as to the accuracy thereof.

National Competent Authority for Drugs

State Medicines Control Agency
Žirmūnų g. 139A
09120 Vilnius, Lithuania
Tel: +370 5 263 9264
Tel: +370 5 263 9265
email: vvkt[at]vvkt.lt
Web: www.vvkt.lt

National Competent Authorites for Tissues and Cells

Hospital exemption for ATMPs

How many ATMPs legally on the market: none
Prepared on a routine basis:
Which fall under the hospital exemption:
Criteria applied for HE: The rules on manufacture of advanced therapy medicinal products for individual patients were approved by the Minister of Health of Lithuania in 2010. An entity is allowed to manufacture ATMPs on non-routine bases for individual patients if it possesses a permit issued by the State Medicine Control Agency at the Ministry of Health of the Republic of Lithuania. ATMPs must be prepared on non-routine bases, when different (modified) manufacturing processes are applied for every MP or when the same ATMP is manufactured with the frequency that may not be attributed to the routine manufacture. An entity is eligible to get a permit if it possesses a health care licence and meets manufacturing and control requirements approved by the Minister of Health.

Please Note: This content is based upon information provided by the Member States of the European Union.
The AGORA consortium cannot provide any guarantee as to the accuracy thereof.

National Competent Authority for Drugs

Medicines Authority
203 Rue D´Argens
GZR 03 Gzira, Malta
Tel: +356 23439000
Fax: +356 23439161
email: info.medicinesauthority[at]gov.mt
Web: www.medicinesauthority.gov.mt

National Competent Authorites for Tissues and Cells

Hospital exemption for ATMPs

How many ATMPs legally on the market: Until 19 April 2012, no applications for ATMPs had been recieved by the national Competent Authorities.
Prepared on a routine basis:
Which fall under the hospital exemption:
Criteria applied for HE: No hospital exemption request for ATMP have been received until 19 April 2012

Please Note: This content is based upon information provided by the Member States of the European Union.
The AGORA consortium cannot provide any guarantee as to the accuracy thereof.

National Competent Authority for Drugs

Medicines Evaluation Board
Graadt van Roggenweg 500
3531 AH Utrecht, The Netherlands
Tel: +31 88 224 8000
Fax: +31 88 224 8001
Contact: Submit your Question…

National Competent Authorites for Tissues and Cells

Healthcare Inspectorate
Wilhelmina van Pruisenweg 52
2595 AN The Hague, The Netherlands
Tel: +31 088 120 5000
Fax: +31 70 304 1570
email: loket[at]igz.nl
Web: www.igz.nl

National Academic GMP Experts

Institute: Pharmacell BV
Name: Dr. Sonke Brunswieck
email: s.brunswieck[at]pharmacell.nl
Tel: +31 43 350 99 10
Institute: Leiden University Medical Center
Name: Dr. Pauline Meij
email: p.meij[at]lumc.nl
Tel: +31 71 526 4179

National Academic GMP Expert

Institute: Pharmacell BV
Name: Alexander Vos
email: a.vos[at]pharmacell.nl

National Academic GMP Expert

Institute: Universitair Medish Centrum Utrecht
Name: Dr. Ineke Slaper-Cortenbach
email: i.slaper[at]umcutrecht.nl
Tel: +31 887 556 574

Hospital exemption for ATMPs

How many ATMPs legally on the market: Until 19 April 2012, no applications for ATMPs had been recieved by the national Competent Authorities.
Prepared on a routine basis:
Which fall under the hospital exemption: The Inspectorate approved approximately 5 hospital exemptions
Criteria applied for HE: In the Netherlands a request for a hospital exemption has to be submitted at the Health Care Inspectorate.

Please Note: This content is based upon information provided by the Member States of the European Union.
The AGORA consortium cannot provide any guarantee as to the accuracy thereof.

National Competent Authority for Drugs

Norwegian Medicines Agency
Sven Oftedalsvei 6
0950 Oslo, Norway
Tel: +47 22 89 77 00
Fax: +47 22 89 77 99
email: post[at]legemiddelverket.no
Web: www.legemiddelverket.no

National Competent Authorites for Tissues and Cells

Hospital exemption for ATMPs

How many ATMPs legally on the market:
Prepared on a routine basis:
Which fall under the hospital exemption:
Criteria applied for HE:

Please Note: This content is based upon information provided by the Member States of the European Union.
The AGORA consortium cannot provide any guarantee as to the accuracy thereof.

National Competent Authority for Drugs

Office for Registration of Medicinal Products, Medical Devices and Biocidal Products
41 Zabkowska Str.
03-736 Warsaw, Poland
Tel: +48 22 492 11 00
Fax: +48 22 492 11 09
Web: www.urpl.gov.pl

National Competent Authorites for Tissues and Cells

Main Pharmaceutical Inspectorate
38/40 Długa Str.
00-238 Warsaw, Poland
Tel: +48 22 831 21 31
Fax: +48 22 831 02 44
email: gif[at]gif.gov.pl
Web: www.gif.gov.pl

Hospital exemption for ATMPs

How many ATMPs legally on the market: There are no ATMPs products legally on national market in Poland.
Prepared on a routine basis:
Which fall under the hospital exemption: The Inspectorate approved approximately 5 hospital exemptions
Criteria applied for HE: The Article 3 Nr.7 of Directive 2001/83/EC (Art.28 of Reg.1394/2007) is already implemented to the Polish Pharmaceutical law.

Please Note: This content is based upon information provided by the Member States of the European Union.
The AGORA consortium cannot provide any guarantee as to the accuracy thereof.

National Competent Authority for Drugs

National Authority of Medicines and Health Products
Parque de Saúde de Lisboa – Avenida do Brasil, 53
1749-004 Lisboa, Portugal
Tel: +351 217987100
Fax: +351 217987316
email: infarmed[at]infarmed.pt
Web: www.infarmed.pt

National Competent Authorites for Tissues and Cells

Hospital exemption for ATMPs

How many ATMPs legally on the market: At present Portugal has no ATMP products legally on the market
Prepared on a routine basis:
Which fall under the hospital exemption:
Criteria applied for HE:

Please Note: This content is based upon information provided by the Member States of the European Union.
The AGORA consortium cannot provide any guarantee as to the accuracy thereof.

National Competent Authority for Drugs

National Medicines Agency (Agentia Nationala a Medicamentului si a Dispozitivelor Medicale)
48, Av. Sanatescu
011478 Bucharest, Romania
Tel: +4021 317 11 00
Fax: +4021 316 34 97
Web: www.anm.ro

National Competent Authorites for Tissues and Cells

National Transplant Agency (Agentia Nationala de Transplant – ANT)
Str. Constantin Caracas 2‐8, Sector 1 ‐ 011155 Bucarest, Romania
Tel: + 40317101473
Fax: + 40317101475
email: ant[at]transplant.ro
Web: www.transplant.ro

National Academic GMP Expert

Institute: University of Medicine and Pharmacy
Name: Prof. Carmen Bunu Panaitescu
email: cbunu[at]umft.ro
Tel: +4 0256 490 507

Hospital exemption for ATMPs

How many ATMPs legally on the market: In Romania there are no ATMP products legally on the market.
Prepared on a routine basis:
Which fall under the hospital exemption: The Inspectorate approved approximately 5 hospital exemptions
Criteria applied for HE: The Article 3 Nr.7 of Directive 2001/83/EC (Art.28 of Reg.1394/2007) is already implemented to the Polish Pharmaceutical law.

Please Note: This content is based upon information provided by the Member States of the European Union.
The AGORA consortium cannot provide any guarantee as to the accuracy thereof.

National Competent Authority for Drugs

State Institute for Drug Control
Kvetná 11
825 08 Bratislava 26, Slovakia
Tel: +421 2 5070 1111
Fax: +421 2 5556 4127
email: sukl[at]sukl.sk
Web: www.sukl.sk

National Competent Authorites for Tissues and Cells

Hospital exemption for ATMPs

How many ATMPs legally on the market: In Slovakia there are no ATMP’s legally on the market at the moment
Prepared on a routine basis:
Which fall under the hospital exemption: The Ministry of Health has not received any applications to get a permit for preparation of ATMPs for individual patients yet. The Article 3 (7) of Directive 2001/83/EC (Art.28 of Reg.1394/2007) is already implemented to the Law on Medicinal Products and Medical Devices (§ 14 of Law 362/2011 Coll. ) . Good Manufacturing Practice rules, specially adjusted to this purpose will apply, but no details have been issued yet.
Criteria applied for HE:

Please Note: This content is based upon information provided by the Member States of the European Union.
The AGORA consortium cannot provide any guarantee as to the accuracy thereof.

National Competent Authority for Drugs

Agency for Medicinal Products and Medical Devices of the Republic of Slovenia
(Javna agencija RS za zdravila in medicinske pripomočke – JAZMP)

Ptujska ulica 21
1000 Ljubljana, Slovenia
Tel: + 38 6 8 2000 500
Fax: + 38 6 8 2000 510
email: info[at]jazmp.si
Web: www.jazmp.si

National Competent Authorites for Tissues and Cells

Institute for transplantation of Organs, Tissues and Cells of the Republic of Slovenia
(Zavod RS za presaditve organov in tkiv, Slovenija translplant -ST)

Zaloska 7
SI-1000 Lubljana, Slovenia
Tel: + 38613006864
Fax: + 38613006866
email: Gorazd.cebulc[at]slovenija‐transplant.si
Web: www.slovenija‐transplant.si

National Academic GMP Expert

Institute: Medical Faculty University of Ljubljana
Name: Prof. Dr. Robert Zorec
email: robert.zorec[at]mf.uni-lj.si
Tel: +38 61 5437080

Hospital exemption for ATMPs

How many ATMPs legally on the market: No advanced therapy medicinal products were approved in Slovenia. Four clinical studies concerning the products have been approved in Slovenia (EudraCT No.: 2010-021867-34; 2009-013042-88, 2009-012389-30, 2008-006710-23).
Prepared on a routine basis:
Which fall under the hospital exemption: There were no applications for manufacturing licences for a “hospital exemption”, the implementation of the HE status is ongoing. In this moment we can expect that hospital exemption status will concern eight products considered as hospital exemptions as defined in the Art. 28 of Reg. 1394/2007.
Criteria applied for HE: Criteria are in line with art 3(7) of the Dir. 2001/83/EC and Art 28 of the CR 1394/2007.

Please Note: This content is based upon information provided by the Member States of the European Union.
The AGORA consortium cannot provide any guarantee as to the accuracy thereof.

National Competent Authority for Drugs

Spanish Agency for Medicines and Health Products
Parque Empresarial Las Mercedes Edificio 8C.
Campezo, 1, 28022 Madrid, Spain
Web: www.aemps.gob.es

National Competent Authorites for Tissues and Cells

Hospital exemption for ATMPs

How many ATMPs legally on the market: ChondroCelect (centrally authorised). We also have other products in hospital use, belonging to one of the following three categories: corneal limbal stem cells, chondrocytes and skin keratinocytes. These products are manufactured by a non-industrial process and have a “historical”, consolidated use previous to the ATMP Reg. 1394/2007, and will be regulated under the HE clause by a project currently under development in Spain.
Prepared on a routine basis: Only ChondroCelet
Which fall under the hospital exemption: For the moment, we only envision to regulate under the hospital exemption the nonindustrially produced ATMPs that have been “historically” used in Spain, as described above.
Criteria applied for HE: In the future, once that the project of regulation in Spain is approved, we expect other products could apply for authorisation under the HE.

Please Note: This content is based upon information provided by the Member States of the European Union.
The AGORA consortium cannot provide any guarantee as to the accuracy thereof.

National Competent Authority for Drugs

Medical Products Agency (Läkemedelsverke)
Dag Hammarskjölds väg 42
Box 26, 751 03 Uppsala, Sweden
Tel: +46 18 17 46 00
Fax: +46 18 54 85 66
email: registrator[at]mpa.se
Web: www.lakemedelsverket.se

National Competent Authorites for Tissues and Cells

National Academic GMP Expert

Institute: Lunds Universitet
Name: Dr. Stefan Scheding
email: stefan.scheding[at]med.lu.se
Tel: +46-46-223331

National Academic GMP Expert

Institute: Karolinska University Hospital
Name: Pontus Blomberg
email: pontus.blomberg[at]karolinska.se
Tel: +46-8-58 58 36 58

Hospital exemption for ATMPs

How many ATMPs legally on the market: In Sweden one can identify two types of products that can be considered legally on the market although no formal decision has been made: These products are: Mesenchymal stem cells for Graft versus Host disease and a Chondrocyte implantation product.
Prepared on a routine basis: The Chondrocyte Implantation product can be considered to be produced on a routine basis.
Which fall under the hospital exemption:
Criteria applied for HE: From May 1st the manufacturers need to apply for a manufacturing licence for “hospital exemption products”. Provisions from the Medical Products Agency sets up the specific requirements for the “hospital exemption products”. So far (Dec. 2011) only one manufacturer has applied for a manufacturing licence for a tissue engineered product.

Please Note: This content is based upon information provided by the Member States of the European Union.
The AGORA consortium cannot provide any guarantee as to the accuracy thereof.

National Competent Authority for Drugs

Swiss Agency for Therapeutic Products (Swissmedic)
Hallerstrasse 7
P.O. Box 3000 Bern 9, Switzerland
Tel: +41 31 322 02 23
Fax: +41 31 322 02 12
Web: www.swissmedic.ch/?lang=en

National Competent Authorites for Tissues and Cells

Federal Office for Public Health – Section Transplantation
Seilerstrasse 8
3003 Bern, Switzerland
Tel: + 41 31 3235154
Fax: + 41 31 3226233
Web: www.bag.admin.ch

National Academic GMP Expert

Institute: University Hospital Basel
Name: Dr. Christian Kalberer
email: ckalberer[at]uhbs.ch

Hospital exemption for ATMPs

How many ATMPs legally on the market:
Prepared on a routine basis:
Which fall under the hospital exemption:
Criteria applied for HE:

Please Note: This content is based upon information provided by the Member States of the European Union.
The AGORA consortium cannot provide any guarantee as to the accuracy thereof.

National Competent Authority for Drugs

Medicines and Healthcare products Regulatory Agency (MHRA)
151 Buckingham Palace Road
Victoria
London, SW1W 9SZ, United Kingdom
Tel: +44 20 3080 6000
email: info[at]mhra.gsi.gov.uk
Web: www.mhra.gov.uk

National Competent Authorites for Tissues and Cells

Human Tissue Athority (HTA)
151 Buckingham Palace Road
Victoria
London, SW1W 9SZ, United Kingdom
Tel: +44 20 7269 1900
Fax: +44 20 7269 1999
email: enquiries[at]hta.gov.uk
Web: www.hta.gov.uk

National Academic GMP Experts

Institute: University College London
Name: Dr. Mark Lowdell
email: m.lowdell[at]ucl.ac.uk
Tel: +44-207-830-2183
Institute: University of Manchester
Name: Dr. Ryan Guest
email: ryan.guest[at]manchester.ac.uk
Tel: +44 (0)161 606 7278

National Academic GMP Expert

Institute: University of Newcastle upon Tyne
Name: Prof. Anne Dickinson
email: anne.dickinson[at]newcastle.ac.uk
Tel: +44-191-222-5866

National Academic GMP Expert

Institute: Imperial College London
Name: Prof. Jane Apperley
email: j.apperley[at]imperial.ac.uk
Tel: +44-208-383-3237

Hospital exemption for ATMPs

How many ATMPs legally on the market: 18 authorisations to manufacture and supply unlicensed ATMPs under the terms of the exemption provided by Article 5(1) of Directive 2001/83/EC (the UK’s Specials scheme) have been granted.
Prepared on a routine basis:
Which fall under the hospital exemption: To date, the UK has not issued any authorisations for ATMPs to be made under the hospital exemption.
Criteria applied for HE: The UK has developed guidance for arrangements under the hospital exemption scheme, which we notified to the Commission.

Please Note: This content is based upon information provided by the Member States of the European Union.
The AGORA consortium cannot provide any guarantee as to the accuracy thereof.