Source: http://agora-gmp.org/interactive-map/
Timestamp: 2017-10-20 17:48:31
Document Index: 760193875

Matched Legal Cases: ['Art.28', 'Art.28', '§ 14', 'Art. 28', 'art 3', 'Art 28']

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National Competent Authority for Drugs
(Österreichische Agentur für Gesundheit und Ernährungssicherheit GmbH)
Tel: +43 5 0555-0
National Competent Authorites for Tissues and Cells
(Austrian Federal Office for Safety in Health Care)
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
Name: Prof. Nina Worel
email: nina.worel[at]meduniwien.ac.at
Tel: +43-1-404-005-308
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.
Tel: +32 2 524 7111
email: info.medicines[at]fagg-afmps.be
Web: www.fagg-afmps.be
Institute: Université Libre de Bruxelles (ULB)
Name: Alain Delforge
email: alain_delforge[at]ulb.ac.be
Tel: +32-2 541-3725
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
Tel: +359 2 890 35 55
Fax: +359 2 890 34 34
email: bda[at]bda.bg
Web: www.bda.bg
Executive Agency for Transplantation (EAT)
112 Bratia Miladinovi Str.
Tel: +359 2 813 50 10
Fax:: +359 2 931 61 51
email: iat[at]bgtransplant.bg
Name: Lubomir Arseniev
email: arseniev.lubomir[at]mh-hannover.de
Tel: +49-511-532-7987
Tel: +385 1 4884 100
email: halmed[at]halmed.hr
Web: www.almp.hr
How many ATMPs legally on the market: 0 (application for ChondroCelect received)
Prepared on a routine basis:
Criteria applied for HE:
Ministry of Health-Pharmaceutical Services
How many ATMPs legally on the market: 0
100 41 Praha 10; Czech Republic
Tel: +420 272 185 333
Fax: +420 272 185 756
email: infs[at]sukl.cz
How many ATMPs legally on the market: GTMPs: 0; CBMPs: 3 in clinical trials; TEPs: 2 (autologous chondrocytes)
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
email: sst[at]sst.dk
Web: www.laegemiddelstyrelsen.dk
Institute: Copenhagen University Hospital, Rigshospitalet, Department of Clinical Immunology
Name: Dr. Anne Fischer-Nielsen,
email: anne.fischer-nielsen@rh.regionh.dk
How many ATMPs legally on the market: 1 (Genzymes MACI); MAA expected
Which fall under the hospital exemption: 1 (Genzymes MACI); MAA expected
Tel: +372 737 41 40
Fax: +372 737 41 42
email: inf[at]ravimiamet.ee
Web: www.ravimiamet.ee
Tel: +358 29 522 3341
Fax: +358 9 4733 4339
Web: www.fimea.fi
Institute: Finnish Red Cross Blood Service
Name: Johanna Nystedt
email: Johanna.Nystedt[at]veripalvelu.fi
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.
Tel: +33 1 55 87 30 00
Web: www.ansm.sante.fr
Institute: Stromalab
Name: PhD Luc Sensebé
email: luc.sensebe[at]efs.sante.fr
Tel: +33-561283760
Institute: Institut Paoli-Calmettes
Name: Prof. Christian Chabannon
email: chabannonc[at]marseille.fnclcc.fr
Tel: + 33-4-91-22-34-41
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.
63225 Langen; Germany
Contact: Bettina Ziegele, M. A., Koordinatorin Innovationsbüro
Tel: +49 6103 77 1012, +49 6103 77 1033
email: innovation[at]pei.de
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
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
Institute: Medizinische Hochschule Hannover
Name: Prof. Dr. Ulrike Köhl
email: koehl.ulrike[at]mh-hannover.de
Tel: +49-511-532-5718
Name: Prof. Dr. Matthias Edinger
email: matthias.edinger[at]klinik.uni-regensburg.de
Tel: +49-941-944-5580
Name: Prof. Matthias Eyrich,
email: Eyrich_M@kinderklinik.uni-wuerzburg.de
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
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.
Messogion Avenue 284
Tel: +30 213 2040 200
Fax: +30 210 6545 535
email: relation[at]eof.gr
Institute: Stem Health
Name: Eugenia Loannidi
email: eioannidi@stem-health.eu
Tel: + 30 6975883069
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).
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.
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
ÁNTSZ (National Public Health and Medical Officer’s Service)
Albert Flórián út 2-6, Hungary
Web: www.antsz.hu/en
Institute: Semmelweis University
Name: Balazs Sarkadi
email: sarkadi[at]biomembrane.hu
Tel: +36-1-3724316
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.
Tel: +354 520 2100
Fax: +354 561 2170
email: ima[at]ima.is
Web: www.imca.is
How many ATMPs legally on the market: No Advanced Therapy Medicinal Products are legally on our market or used in hospitals in Iceland.
email: imb[at]imb.ie
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.
Criteria applied for HE: Manufacturer’s authorisation required-none yet issued. A guideline has been prepared for interested parties.
Italian Medicines Agency (Agenzia Italiana del Farmaco – AIFA)
181 Via del Tritone
Tel: +39 6 5978401
Web: www.agenziafarmaco.it
Italian National Transplant Center (Centro Nazionale Trapianti -CNT)
Viale Reginal Elena 299
Tel: + 39 649904040‐4041
Fax: + 39 649904101
Web: www.trapianti.salute.gov.it
Institute: Ospedali Riuniti
Name: Dr. Martino Introna
email: mintrona[at]ospedaliriuniti.bergamo.it
Institute: Bortolo Hospital
Name: Dr. Giuseppe Astori
email: astori[at]hemato.ven.it
Tel: +39 0444751721
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.
Criteria applied for HE: draft technical text available; the verification of legal aspects is currently in progress.
2120 Luxembourg; Luxembourg
email: ministere-sante[at]ms.etat.lu
Web: www.ms.etat.lu
How many ATMPs legally on the market: 2 ATMPs have been centrally authorized, none is in use in Luxembourg
15 Jersikas Street
1003 Riga, Latvia
Tel: +371 7078424
Fax: +371 7078428
email: info[at]zva.gov.lv
Web: www.zva.gov.lv
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.
Office of Health/ Department of Pharmaceuticals
Äulestr 512
9490 Vaduz; Liechtenstein
Tel: +370 5 263 9264
Tel: +370 5 263 9265
email: vvkt[at]vvkt.lt
Web: www.vvkt.lt
How many ATMPs legally on the market: none
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.
203 Rue D´Argens
GZR 03 Gzira, Malta
Tel: +356 23439000
email: info.medicinesauthority[at]gov.mt
Web: www.medicinesauthority.gov.mt
How many ATMPs legally on the market: Until 19 April 2012, no applications for ATMPs had been recieved by the national Competent Authorities.
Criteria applied for HE: No hospital exemption request for ATMP have been received until 19 April 2012
3531 AH Utrecht, The Netherlands
Tel: +31 88 224 8000
Contact: Submit your Question…
Tel: +31 088 120 5000
Fax: +31 70 304 1570
email: loket[at]igz.nl
Web: www.igz.nl
Institute: Pharmacell BV
Name: Dr. Sonke Brunswieck
Tel: +31 43 350 99 10
Institute: Leiden University Medical Center
Name: Dr. Pauline Meij
Tel: +31 71 526 4179
email: a.vos[at]pharmacell.nl
Institute: Universitair Medish Centrum Utrecht
Name: Dr. Ineke Slaper-Cortenbach
Tel: +31 887 556 574
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.
Tel: +47 22 89 77 00
email: post[at]legemiddelverket.no
Web: www.legemiddelverket.no
Tel: +48 22 492 11 00
Fax: +48 22 492 11 09
Web: www.urpl.gov.pl
38/40 Długa Str.
Tel: +48 22 831 21 31
Fax: +48 22 831 02 44
email: gif[at]gif.gov.pl
Web: www.gif.gov.pl
How many ATMPs legally on the market: There are no ATMPs products legally on national market in Poland.
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.
Parque de Saúde de Lisboa – Avenida do Brasil, 53
1749-004 Lisboa, Portugal
Tel: +351 217987100
email: infarmed[at]infarmed.pt
How many ATMPs legally on the market: At present Portugal has no ATMP products legally on the market
National Medicines Agency (Agentia Nationala a Medicamentului si a Dispozitivelor Medicale)
48, Av. Sanatescu
Tel: +4021 317 11 00
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
Institute: University of Medicine and Pharmacy
Name: Prof. Carmen Bunu Panaitescu
email: cbunu[at]umft.ro
Tel: +4 0256 490 507
How many ATMPs legally on the market: In Romania there are no ATMP products legally on the market.
825 08 Bratislava 26, Slovakia
Tel: +421 2 5070 1111
Fax: +421 2 5556 4127
email: sukl[at]sukl.sk
How many ATMPs legally on the market: In Slovakia there are no ATMP’s legally on the market at the moment
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.
(Javna agencija RS za zdravila in medicinske pripomočke – JAZMP)
Tel: + 38 6 8 2000 500
Fax: + 38 6 8 2000 510
email: info[at]jazmp.si
Web: www.jazmp.si
Institute for transplantation of Organs, Tissues and Cells of the Republic of Slovenia
(Zavod RS za presaditve organov in tkiv, Slovenija translplant -ST)
SI-1000 Lubljana, Slovenia
Tel: + 38613006864
Fax: + 38613006866
email: Gorazd.cebulc[at]slovenija‐transplant.si
Web: www.slovenija‐transplant.si
Institute: Medical Faculty University of Ljubljana
Name: Prof. Dr. Robert Zorec
email: robert.zorec[at]mf.uni-lj.si
Tel: +38 61 5437080
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).
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.
Parque Empresarial Las Mercedes Edificio 8C.
Campezo, 1, 28022 Madrid, Spain
Web: www.aemps.gob.es
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.
Medical Products Agency (Läkemedelsverke)
Box 26, 751 03 Uppsala, Sweden
Tel: +46 18 17 46 00
email: registrator[at]mpa.se
Institute: Lunds Universitet
Name: Dr. Stefan Scheding
email: stefan.scheding[at]med.lu.se
Tel: +46-46-223331
Name: Pontus Blomberg
email: pontus.blomberg[at]karolinska.se
Tel: +46-8-58 58 36 58
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.
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.
P.O. Box 3000 Bern 9, Switzerland
Tel: +41 31 322 02 23
Web: www.swissmedic.ch/?lang=en
Federal Office for Public Health – Section Transplantation
Tel: + 41 31 3235154
Fax: + 41 31 3226233
Web: www.bag.admin.ch
Institute: University Hospital Basel
Name: Dr. Christian Kalberer
email: ckalberer[at]uhbs.ch
London, SW1W 9SZ, United Kingdom
Tel: +44 20 3080 6000
email: info[at]mhra.gsi.gov.uk
Human Tissue Athority (HTA)
Tel: +44 20 7269 1900
Fax: +44 20 7269 1999
email: enquiries[at]hta.gov.uk
Web: www.hta.gov.uk
Name: Dr. Mark Lowdell
Tel: +44-207-830-2183
Name: Dr. Ryan Guest
email: ryan.guest[at]manchester.ac.uk
Tel: +44 (0)161 606 7278
Institute: University of Newcastle upon Tyne
Name: Prof. Anne Dickinson
email: anne.dickinson[at]newcastle.ac.uk
Tel: +44-191-222-5866
Name: Prof. Jane Apperley
email: j.apperley[at]imperial.ac.uk
Tel: +44-208-383-3237
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.
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.