EU REGULATORY SUBMISSIONS

• Introduction
• European union member states
• Committees of EMEA
• Marketing authorization procedures
 Centralized procedure (CP)
 National procedure (NP)
 Mutual recognition procedure (MRP)
 Decentralized procedure (DCP)

Introduction to the EMA
• Prior to 2004, it was known as the European Agency for the Evaluation of
Medicinal Products or European Medicines Evaluation Agency (EMEA)
• The European Medicines Agency (EMA) is a decentralised agency of the
European Union (EU), located in London. It began operating in 1995. The Agency
is responsible for the scientific evaluation, supervision and safety monitoring of
medicines in the EU.
• EMA protects public and animal health in 28 EU Member States, as well as the
countries of the European Economic Area, by ensuring that all medicines available
on the EU market are safe, effective and of high quality.

European union member states
Belgium (BE) Greece (EL) Lithuania (LT) Portugal (PT)
Bulgaria (BG) Spain (ES) Luxembourg (LU) Romania (RO)
Czech Republic (CZ) France (FR) Hungary (HU) Slovenia (SI)
Denmark (DK) Croatia (HR) Malta (MT) Slovakia (SK)
Germany (DE) Italy (IT) Netherlands (NL) Finland (FI)
Estonia (EE) Cyprus (CY) Austria (AT) Sweden (SE)
Ireland (IE) Latvia (LV) Poland (PL) United Kingdom (UK)
European free trade association
Iceland (IS) Norway (NO)
Liechtenstein (LI) Switzerland (CH)

United Kingdom’s (UK) withdrawal from the EU
• EMA has published important information to help users of the centralised
procedure prepare for the expected consequences of 'Brexit', including their
obligations related to establishment within the European Economic Area (EEA).
For more information, see UK’s withdrawal from the EU.
• On 29 March 2017, the United Kingdom (UK) notified the European Council of
its intention to withdraw from the European Union (EU), a process known as
'Brexit'. The European Medicines Agency (EMA) is making preparations to ensure
that it can continue to deliver on its mission and protect public and animal health
after the UK leaves the EU on 30 March 2019, the date currently set by the
timeframe provided in Article 50 of the Treaty on European Union.
• One of the consequences of Brexit is that EMA will relocate to Amsterdam, the
Netherlands, where it has to take up its operations on 30 March 2019 at the latest.

REGULATORY BODY - EMA
 European medical Agency (EMA):
 Decentralized body of EU with headquarters in London (going to move
Amsterdam)
 Protection and promotion of public and animal health, through the
evaluation and supervision of medicines for human and veterinary use
 There are 7 scientific committees works under EMA in EU and EEA-
EFTA

Committees of EMEA
Committee for Medicinal Products for Human Use (CHMP)
Pharmacovigilance Risk Assessment Committee (PRAC)
 Committee for Medicinal Products for Veterinary Use (CVMP)
 Committee for Orphan Medicinal Products (COMP)
 Committee on Herbal Medicinal Products (HMPC)
 Pediatric Committee (PDCO)
 Committee for Advanced Therapies (CAT)

MARKETING AUTHORIZATION PROCEDURES
 CENTRALIZED PROCEDURE (CP)
 NATIONAL PROCEDURE (NP)
 MUTUAL RECOGNITION PROCEDURE (MRP)
 DECENTRALIZED PROCEDURE (DCP)

CENTRALIZED PROCEDURE
 Under the centralised authorisation procedure, pharmaceutical companies submit
a single marketing-authorisation application to EMA.
 This allows the marketing-authorisation holder to market the medicine throughout the
EU.
 MA's Committee for Medicinal products for Human Use (CHMP) or Committee for
Medicinal products for Veterinary Use (CVMP) carry out a scientific assessment of the
application and give a recommendation on whether the medicine should be marketed or
not.
 Once granted by the European Commission, the centralised marketing authorisation
is valid in all EU Member States as well as in the European Economic Area (EEA)
countries Iceland, Liechtenstein and Norway.

The centralised procedure is mandatory for:
 Human medicines containing a new active substance to treat:
HIV or AIDS; Cancer; Diabetes; Neurodegenerative diseases; Viral diseases; auto-immune and other
immune dysfunctions;
 Medicines derived from biotechnology processes, such as genetic engineering;
 Advanced-therapy medicines such as gene-therapy, somatic cell-therapy or tissue-
engineered medicines;
 Orphan medicines (medicines for rare diseases);
 Veterinary medicines for use as growth or yield enhancers.
CENTRALIZED PROCEDURE

CENTRALIZED PROCEDURE - Timelines

NATIONAL PROCEDURE
 Marketing authorization in one particular EU country
 Each EU Member State has its own national authorisation procedures.
 Approval time for drug product varies within member states of EU
 Applicable to abridged drug products
 Not applicable to biotechnology products
 Can also serve as the first phase of a Mutual Recognition procedure
 National abridged standard and complex applications takes approximately 210
days to be approved in UK
List of national competent authorities in the EEA:

Country Name Contact details Logo
Austria
Austrian
Agency for
Health and
Food Safety
Spargelfeldstraße 191
1220 Wien
Austria
Tel. +43 5 0555-0
Fax +43 5 0555-22019
www.ages.at
Belgium
Federal Agency
for Medicines
and Health
Products
Eurostation building, block 2
place Victor Horta, 40/ 40
1060 Brussels
Belgium
Tel. +32 2 524 7111
E-mail: info.medicines@fagg-
afmps.be
www.fagg-afmps.be/
Bulgaria
Bulgarian Drug
Agency
8 Damyan Gruev Str.
Sofia 1303
Bulgaria
Tel. +359 2 890 35 55
Fax +359 2 890 34 34
E-mail: bda@bda.bg
www.bda.bg
Croatia
Agency for
medicinal
products and
medical devices
of Croatia
Ksaverska cesta 4
10 000 Zagreb
Tel. +385 1 4884 100
Fax: +385 1 4884 110
E-mail: halmed@halmed.hr
www.almp.hr
Cyprus
Ministry of
Health -
Pharmaceutical
Services
Pharmaceutical Services
Ministry of Health
1475 Nicosia
Cyprus
Tel: +357 22608620
Fax: +357 22608649
E-mail: phscentral@phs.moh.gov.cy
www.moh.gov.cy/phs
Czech
Republic
State Institute
for Drug
Control
Srobárova 48
100 41 Praha 10
Czech Republic
Tel. +420 272 185 333
Fax +420 272 185 756
E-mail: infs@sukl.cz
www.sukl.cz
Denmark
Danish
Medicines
Agency
Axel Heides Gade 1
2300 København S
Denmark
Tel. +45 7222 7400
E-mail: dkma@dkma.dk
www.laegemiddelstyrelsen.dk

Estonia
State Agency of
Medicines
1 Nooruse Street
50411 Tartu
Estonia
Tel. +372 737 41 40
Fax +372 737 41 42
E-mail: info@ravimiamet.ee
www.ravimiamet.ee
Finland
Finnish
Medicines
Agency
P.O. Box 55
FI-00034 FIMEA
Finland
Tel. +358 29 522 3341
Fax +358 9 4733 4339
www.fimea.fi
France
National
Agency for the
Safety of
Medicine and
Health Products
143-147 bd Anatole France
93285 Saint Denis cedex
France
Tel. +33 1 55 87 30 00
www.ansm.sante.fr
Germany
Federal Institute
for Drugs and
Medical
Devices
Kurt-Georg-Kiesinger-Allee 3
53175 Bonn
Germany
Tel. +49 (0)228-207-30
Fax +49 (0)228-207-5207
E-mail: poststelle@bfarm.de
www.bfarm.de
Germany
Paul Ehrlich
Institute
Paul-Ehrlich-Straße 51-59
63225 Langen
Germany
Tel. +49 6103 77 0
Fax +49 6103 77 1234
E-mail: pei@pei.de
www.pei.de/
Greece
National
Organization
for Medicines
Messogion Avenue 284
15562 Athens
Greece
Tel. +30 213 2040 200
Fax +30 210 6545 535
E-mail: relation@eof.gr
www.eof.gr
Hungary
National
Institute of
Pharmacy and
Nutrition
Zrínyi U. 3
1051 Budapest
Hungary
Tel. +36 1 88 69 -300
Fax +36 1 88 69-460
E-mail: ogyei@ogyei.gov.hu
www.ogyei.gov.hu

Iceland
Icelandic
Medicines
Agency
Vínlandsleið 14
113 Reykjavík
Iceland
Tel. +354 520 2100
Fax +354 561 2170
E-mail: ima@ima.is
www.imca.is
Ireland
Health Products
Regulatory
Authority
(HPRA)
Kevin O'Malley House,
Earlsfort Centre,
Earlsfort Terrace,
Dublin 2,
Ireland
Tel. +353 1 676 4971
Fax +353 1 676 7836
E-mail: info@hpra.ie
www.hpra.ie
Italy
Italian
Medicines
Agency
Via del Tritone, 181
00187 Roma
Italy
Tel. +39 06 5978401
Fax +39 06 59784312
www.agenziafarmaco.it
Latvia
State Agency of
Medicines
15 Jersikas Street
1003 Riga
Latvia
Tel. +371 7078424
Fax +371 7078428
E-mail: info@zva.gov.lv
www.zva.gov.lv
Liechtenstein
Office of Health
/ Department of
Pharmaceuticals
Äulestr 512
9490 Vaduz
Liechtenstein
c
Lithuania
State Medicines
Control Agency
Žirmūnų g. 139A
09120 Vilnius
Lithuania
Tel. +370 5 263 9264
Tel +370 5 263 9265
E-mail: vvkt@vvkt.lt
www.vvkt.lt

Luxembourg
Ministry of
Health
Allée Marconi
2120 Luxembourg
Luxembourg
E-mail: ministere-sante@ms.etat.lu
www.ms.etat.lu
Malta
Medicines
Authority
203 Rue D´Argens
GZR 03 Gzira
Malta
Tel. +356 23439000
Fax +356 23439161
E-
mail: info.medicinesauthority@gov.
mt
www.medicinesauthority.gov.mt
Netherlands
Medicines
Evaluation
Board
Graadt van Roggenweg 500
3531 AH Utrecht
The Netherlands
Tel. +31 (0) 88 224 8000
Fax +31 (0) 88 224 8001
Contact: Submit your question
Netherlands
Healthcare
Inspectorate
Stadsplateau 1
3521 AZ Utrecht
The Netherlands
Tel. +31 88 120 5000
Fax +31 88 120 5001
E-mail: meldpunt@igz.nl
www.igz.nl
Norway
Norwegian
Medicines
Agency
Postboks 240 Skøyen
0213 Oslo
Norway
Tel. +47 22 89 77 00
E-mail: post@legemiddelverket.no
www.legemiddelverket.no
Poland
Office for
Registration of
Medicinal
Products,
Medical
Devices and
Biocidal
Products
Al. Jerozolimskie 181C
02-222 Warsaw
Poland
Tel. +48 (22) 492 11 00
Fax +48 (22) 492 11 09
www.urpl.gov.pl

Poland
Chief
Pharmaceutical
Inspectorate
Senatorska 12
00-082 Warsaw
Poland
Tel. +48 22 831 21 31
Fax +48 22 831 02 44
E-mail: gif@gif.gov.pl
www.gif.gov.pl
Portugal
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
E-mail: infarmed@infarmed.pt
www.infarmed.pt
Romania
National
Medicines
Agency
48, Av. Sanatescu
011478 Bucharest
Romania
Tel. +4021 317 11 00
Fax +4021 316 34 97
www.anm.ro
Slovakia
State Institute
for Drug
Control
Kvetná 11
825 08 Bratislava 26
Slovakia
Tel. +421 2 5070 1111
Fax +421 2 5556 4127
E-mail: sukl@sukl.sk
www.sukl.sk
Slovenia
Agency for
Medicinal
Products and
Medical
Devices of the
Republic of
Slovenia
Slovenčeva ulica 22
1000 Ljubljana
Slovenia
Tel. + 38 6 8 2000 500
Fax + 38 6 8 2000 510
E-mail: info@jazmp.si
www.jazmp.si
Spain
Spanish Agency
for Medicines
and Health
Products
Parque Empresarial
Las Mercedes Edificio 8C/.
Campezo, 1
28022 Madrid
Spain
www.aemps.gob.es

Sweden
Medical
Products
Agency
Dag Hammarskjölds väg 42 / Box 26
751 03 Uppsala
Sweden
Tel. +46 18 17 46 00
Fax +46 18 54 85 66
E-mail: registrator@mpa.se
www.lakemedelsverket.se
United
Kingdom
Medicines and
Healthcare
Products
Regulatory
Agency
151 Buckingham Palace Road
Victoria
London
SW1W 9SZ
United Kingdom
Tel. +44 (0)20 3080 6000
E-mail: info@mhra.gov.uk
www.mhra.gov.uk

MUTUAL RECOGNITION PROCEDURE (MRP)
 Only applicable if the applicant already has a national marketing authorization
 Not applicable to (biotech) products
 Procedure:
 Application to Reference Member State (RMS)
 First authorization granted by RMS
 Applicant requests mutual recognition
 Dossier consolidated for submission to other “concerned Member States
(CMS)
 Approval from CMS within 90 days

MUTUAL RECOGNITION PROCEDURE (MRP) - Time lines

DECENTRALIZED PROCEDURE (DCP)
 Available pathway if the product has no existing MA in any Member State
 Timeline for the DCP approval is 150 to 300 days
 Not applicable to (biotech) products
 Procedure:
 Identical dossiers sent to RMS and CMS
 RMS prepares preliminary assessment report and sends to CMS – Day 70
 CMS sends any comments to RMS –Day 100
 Clock-off period
 RMS prepares draft assessment report and sends to CMS – Day 120
 CMS sends any comments to RMS –Day 145
 RMS may close procedure if consensus reached –Day 150
 If RMS and CMS cannot reach agreement by Day 150 it referred to the
Coordination group for MRP and DCP for human medicinal products CMD (h)

DECENTRALIZED PROCEDURE (DCP) - Timelines

VARIATIONS
TYPE 1 VARIATION
(NOTIFICATION)
TYPE II VARIATION
• Change in composition of the
finished product
• Change in immediate packaging of
the finished product
TYPE 1A VARIATION
• Change in the name of
the active substance
• Change in ATC code
• Change in name of
address of the marketing
authorisation holder
TYPE 1B VARIATION
• Change in the name of
medicinal product
• Change in retest period of
active substance
• Change in storage
conditions for active
substance

EU REGULATORY SUBMISSIONS

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EU REGULATORY SUBMISSIONS