Dossier requirements for Centrally Authorised Products

9 January 2015
EMA/497021/2012 Rev. 17
Dossier requirements for Centrally Authorised Products (CAPs)
Submission of applications to the European Medicines Agency, Members of the Committee for Medicinal Products
for Human use (CHMP), Committee for Advanced Therapies (CAT)* and Pharmacovigilance Risk Assessment
Committee (PRAC)
Application /
Submission Type
Dossier Requirements for EMA, (Co-)Rapporteurs and Members/Alternates
Full application
Extension
Type IB variation (with PRAC
involvement)
Type II variation (with or without
PRAC involvement)
Mandatory from 1st March 2014: 1 Electronic submission of the application in eCTD format via eSubmission
Gateway or eSubmission Web Client.
CHMP, PRAC and CAT* (when involved) in countries not linked to EMA Common Repository:
1 eCTD version after EMA technical validation (or by start of the content/regulatory validation phase) and after
Validation Supplementary Information
Renewal
30 Churchill Place ● Canary Wharf ● London E14 5EU ● United Kingdom
Telephone +44 (0)20 3660 6000 Facsimile +44 (0)20 3660 5555
Send a question via our website www.ema.europa.eu/contact
An agency of the European Union
© European Medicines Agency, 2015. Reproduction is authorised provided the source is acknowledged.
Application /
Submission Type
Dossier Requirements for EMA, (Co-)Rapporteurs and Members/Alternates
Periodic Safety Update Report
(PSUR)
Post Authorisation Safety Studies
(PASS)
Post-Authorisation Measures (PAMs)
Annual Re-Assessment
Article 20 procedure
Article 31 referral procedure1
Article 107i procedure1
Type IA or IB variation
EMA: Mandatory from 1st March 2014: 1 Electronic submission of the application in eCTD format via eSubmission
Gateway or eSubmission Web Client.
Transfer
Art 61(3) Notification
CHMP: 1 eCTD version at the time of the submission to CHMP (Co)-Rapporteur’s countries not linked to EMA
Common Repository (No CAT* or PRAC submissions required).
1
Nationally authorised products concerned by this procedure should follow the dossier requirements as detailed here.
The above requirements apply to the submission of ‘Responses’, closing sequences or consolidation sequences with notification of procedural withdrawals.
For further information on what to submit at which stage of the application, please refer to Chapter 4 of the Harmonised Guidance for eCTD
Submissions in the EU
Dossier requirements for Centrally Authorised Products (CAPs)
EMA/497021/2012 Rev. 17
For any change on the content of this document, please
email: [email protected]
Page 2/9
Countries using the Common Repository
The submission sent to EMA via eSubmission Gateway/Web Client will be considered delivered also to the following National Competent Authorities’
representatives or alternates:
National Competent Authority
BE, BG, HR, CZ, EE, GR, HU, IS, IT, LI, LT,
LU, MT, NO, PT, RO, SK, SI and ES
representatives or alternates
Dossier Delivery Address
Not applicable
Do not submit additional copies directly to the NCA on CD/DVD
or via CESP as this might lead to validation issues and cause
delays.
Submission via Portal
Submission via EMA eSubmission
Gateway only
Dossier delivery address for the National Competent Authorities of CHMP, CAT* and PRAC members/alternates not linked to EMA Common Repository;
Please note that the address below may be different from the address mentioned on the list of CHMP, CAT and PRAC Committee members. For
submission purposes, only the address listed in the ‘Dossier Delivery Address’ column below should be used, and only one submission is needed. Please
mention the names of the relevant CHMP, CAT and PRAC members on the submission package and/or cover letter.
For names of CHMP, CAT or PRAC members, please refer to the official list of members (click on links below):
List of CHMP members
List of PRAC members
List of CAT members*
* for this committee, the dossier is only required by its members if the product is an advanced therapy (AT).
Countries requiring separate submission:
National Competent Authority
AT representative or alternate
Dossier Delivery Address
AGES PharmMed
Traisengasse 5,
A-1200 Vienna
AUSTRIA
Dossier requirements for Centrally Authorised Products (CAPs)
EMA/497021/2012 Rev. 17
Submission via Portal
YES: submission via CESP
accepted
For any change on the content of this document, please
email: [email protected]
Page 3/9
National Competent Authority
CY representative or alternate
DK representative or alternate
FI representative or alternate
FR representative or alternate
Dossier Delivery Address
Ministry of Health
Pharmaceutical Services
1475 Lefkosia
Nicosia
CYPRUS
Danish Health and Medicines Authority
Axel Heides Gade 1
DK-2300 København S
DENMARK
Finnish Medicines Agency
P.O.Box 55
FI-00034 FIMEA
FINLAND
ANSM
143-147 Bd. Anatole France
93285 Saint Denis Cedex
FRANCE
Submission via Portal
NO (please refer to the CESP
portal for updated status)
http://cesp.hma.eu/Contacts
YES: submission via CESP
accepted
YES: submission via CESP
accepted
NO (please refer to the CESP
portal for updated status)
http://cesp.hma.eu/Contacts
DE representative or alternate
IR representative or alternate
LV representative or alternate
Bundesinstitut für Arzneimittel und Medizinprodukte
Kurt-Georg-Kiesinger-Allee 3
53175 Bonn
GERMANY
Receipts and Validation
Health Products Regulatory Authority
The Earlsfort Centre
Earlsfort Terrace
Dublin 2
IRELAND
State Agency of Medicines
15 Jersikas iela
Riga, LV-1003
LATVIA
YES: submission via CESP
accepted
YES: submission via CESP
accepted
YES: submission via CESP
accepted
Please refer to the CESP portal for
further information
http://cesp.hma.eu/Contacts
NL representative or alternate
College ter Beoordeling van Geneesmiddelen
Graadt van Roggenweg 500
3531 AH Utrecht
THE NETHERLANDS
Dossier requirements for Centrally Authorised Products (CAPs)
EMA/497021/2012 Rev. 17
YES: submission via CESP
accepted
For any change on the content of this document, please
email: [email protected]
Page 4/9
National Competent Authority
PL representative or alternate
Dossier Delivery Address
Office for Medicinal Products, Medical Devices and Biocides
Al. Jerozolimskie 181C
02-222 Warsaw
POLAND
Submission via Portal
NO (please refer to the CESP
portal for updated status)
http://cesp.hma.eu/Contacts
SE representative or alternate
UK representative or alternate
Medical Products Agency
Dag Hammarskjölds väg 42,
P.O.Box 26
751 03 Uppsala
SWEDEN
Medicines and Healthcare products Regulatory Agency
151 Buckingham Palace Road, Victoria
London, SW1W 9SZ
UNITED KINGDOM
Dossier requirements for Centrally Authorised Products (CAPs)
EMA/497021/2012 Rev. 17
YES: submission via CESP
accepted
YES: submission via CESP
accepted
For any change on the content of this document, please
email: [email protected]
Page 5/9
Names and Dossier delivery address for CHMP Co-Opted Members and for PRAC and
CAT members nominated by the European Commission
Only send applications to the below mentioned address if answer to “separate submission required?” is YES.
Name
Dossier Delivery Address
Separate submission
required
CHMP Co-Opted Members:
Jan Mueller-Berghaus
Hubert Leufkens
Jean-Louis Robert
Sol Ruiz
Robert James Hemmings
Paul-Ehrlich-Institute
Paul-Ehrlich Str. 51-59
63225 Langen
GERMANY
College ter Beoordeling van Geneesmiddelen
Graadt van Roggenweg 500
3531 AH Utrecht
THE NETHERLANDS
Laboratoire National de Santé, EP
Département des Laboratoires Officiels d'Analyses de Contrôle
1 rue Louis Rech, L-3555 Dudelange
Adresse postale: B.P. 72,
L - 3401 Dudelange
LUXEMBOURG
Agencia Española del Medicamento y Productos Sanitarios
Parque Empresarial Las Mercedes
Edificio 8
C/Campezo 1
28022 Madrid
SPAIN
Medicines and Healthcare products Regulatory Agency
151 Buckingham Palace Road, Victoria
London, SW1W 9SZ
UNITED KINGDOM
Names and Dossier delivery address for CHMP Co-Opted Members and for PRAC and CAT members nominated by the European
Commission
EMA/497021/2012 Rev. 17
YES: submission via CESP
accepted
NO
YES
NO
NO
For any change on the content of this document, please
email: [email protected]
Page 6/9
Name
Dossier Delivery Address
Separate submission
required
PRAC Independent Scientific experts:
Jane Ahlqvist Rastad
Marie Louise (Marieke) De Bruin
Stephen J. W. Evans
Medical Products Agency
Dag Hammarskjölds väg 42,
P.O.Box 26
751 03 Uppsala
SWEDEN
College ter Beoordeling van Geneesmiddelen
Graadt van Roggenweg 500
3531 AH Utrecht
THE NETHERLANDS
N/A
NO
NO
NO
Brigitte Keller-Stanislawski
Herve Le Louet
Lennart Waldenlind
Paul-Ehrlich-Institute
Paul-Ehrlich Str. 51-59
63225 Langen
GERMANY
Hopital Henri Mondor, Centre de Pharmacovigilance&Information
sur le medicament
51 Avenue du Mal de Lattre de Tassigny,
94010 Creteil Cedex
FRANCE
Medical Products Agency
Dag Hammarskjölds väg 42,
P.O.Box 26
751 03 Uppsala
SWEDEN
YES: submission via CESP
accepted
YES
NO
PRAC Representatives of Healthcare
Professionals
Member: Filip Babylon
N/A
NO
Names and Dossier delivery address for CHMP Co-Opted Members and for PRAC and CAT members nominated by the European
Commission
EMA/497021/2012 Rev. 17
For any change on the content of this document, please
email: [email protected]
Page 7/9
Name
Dossier Delivery Address
Separate submission
required
Alternate: Kirsten Myhr
Health Action International-Europe (HAI), Department of
Pharmacology
Relis Drug Information & Pharmacovigilance Centre
Ullevål University Hospital
0407 Oslo
NORWAY
NO
PRAC Representatives of Patient
Organisation
Member: Albert van der Zeijden
Alternate: Marco Greco
International Alliance of Patients' Organizations (IAPO)
Louise Kerlinghof 20
3571 TR Utrecht
NETHERLANDS
EFCCA
c / o Avv. Marco Greco
Via Carducci 9
20062 CASSANO D'ADDA (MI)
ITALY
NO
NO
CAT Representatives of Healthcare
Professionals: only required if the product
is an advanced therapy (AT)
Member: Pieter Doevendans
Alternate: Esteve Trias-Adroher
European Society of Cardiology (ESCARDIO)
Care of: University Medical Centre Utrecht Division Heart and Lungs
Department of Cardiology, E 03.511
PO Box 85500
3508 GA UTRECHT
The Netherlands
European Association of Tissue Banks (EATB)
Care of: Parc Sanitari Sant Joan De Deu
Carrer/Dr Antoni Pujadas, 42, Edifi Clínica Pujadas
08830 Sant Boi de Llobregat
Spain
Names and Dossier delivery address for CHMP Co-Opted Members and for PRAC and CAT members nominated by the European
Commission
EMA/497021/2012 Rev. 17
YES
YES
For any change on the content of this document, please
email: [email protected]
Page 8/9
Name
Dossier Delivery Address
Separate submission
required
Member: Bernd Gänsbacher
Europastrasse 18
39058 Sarnthein
Prov. Bozen
Italy
European Association of Tissue Banks (EATB)
Care of: EHB, International Ass c/o Military Hospital
Rue Bruynstraat 200
1120 Brussels
Belgium
YES
European Association for Rare Diseases (EURORDIS)
Care of: Via N. Badaloni, 35
56122 Pisa
Italy
European Parkinson's Association (EPDA)
1, Northumberland Avenue, Trafalgar Square
London, WC2N 5BW
United Kingdom
European Genetic Alliances Network (EGAN)
Koninginnelaan 23
3762 DA Soest
The Netherlands
YES
Alternate: Ramadan Jashari
YES
CAT Representatives of Patient
Organisations: only required if the product
is an advanced therapy (AT)
Member: Michele Lipucci di Paola
Member: Kieran Breen
Alternate: Mariette Driessens
Names and Dossier delivery address for CHMP Co-Opted Members and for PRAC and CAT members nominated by the European
Commission
EMA/497021/2012 Rev. 17
YES
YES
For any change on the content of this document, please
email: [email protected]
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