Regulatory pathways for bringing herbal medicinal products to market in EU Member States

Bringing herbal medicinal products to market within the EU

Law

Companies seeking to bring herbal medicinal products to the market in EU Member States should follow the national procedures overseen by national competent authorities(1).

There are three main regulatory pathways for bringing a herbal medicinal product to market in EU Member States:

Regulatory pathway

Main requirements on safety and efficacy

Where to apply

Traditional use registration

(Article 16a(1) of Directive 2001/83/EC)

 

  • No clinical tests and trials on safety and efficacy are required as long as sufficient safety data and plausible efficacy are demonstrated
  • Involves assessment of mostly bibliographic safety and efficacy data
  • Must have been used for at least 30 years, including at least 15 years within the EU
  • Are intended to be used without the supervision of a medical practitioner and are not administered by injection
  • National competent authority of a Member State for national, mutual recognition and decentralised procedures

Well-established use marketing authorisation

(Article 10a of Directive 2001/83/EC)

  • Scientific literature establishing that the active substances of the medicinal products have been in well-established medicinal use within the EU for at least ten years, with recognised efficacy and an acceptable level of safety
  • Involves assessment of mostly bibliographic safety and efficacy data
  • National competent authority of a Member State for national, mutual recognition and decentralised procedures
  • EMA if centralised procedure applies
Stand-alone or mixed application (Article 8(3) of Directive 2001/83/EC)
  • Safety and efficacy data from the company’s own development or a combination of own studies and bibliographic data
  • National competent authority of a Member State for national, mutual recognition and decentralised procedures
  • EMA if centralised procedure applies

For further information, see:

  • Rules governing medicinal products in the European Union, Notice to applicants, Volume 2A, Chapter 1 on marketing authorisation and Chapter 2 on mutual recognition
  • CMDh Q&A Traditional herbal medicinal products (CMDh/287/2013)

Regardless of partially simplified requirements on safety and efficacy data, a full quality dossier is required for all herbal medicinal products (see section ‘quality’ in scientific guidelines) as well as other fundamental principles that are applicable to all medicinal products including good manufacturing practice, pharmacovigilance and requirements on packaging and labelling.

Legal framework

simplified registration procedure for traditional herbal medicinal products was introduced in 2004 through Directive 2004/24/EC (the Herbal Directive), which amends Directive 2001/83/EC. It aims to protect public health and secure the free movement of herbal medicinal products within the EU.

While most individual herbal medicinal products continue to be licensed nationally by Member States, the process for licensing and information on herbal substances and preparations is increasingly harmonised across the EU.

One impact of the Herbal Directive is that all Member States can refer to one unique set of information on a herbal substance or herbal preparation when evaluating marketing applications for herbal medicinal products from companies.

This information is provided in EU herbal monographs or EU list entries.

A brief description of the procedure is available on the European Commission’s website under point 3.4 of the Notice to Applicants Volume 2A – Procedures for marketing authorisation, Chapter 1 – Marketing Authorisation. For further information, please refer to the relevant national competent authority.


(1) The national competent authorities are primarily responsible for the authorisation of medicines available in the EU

List of national competent authorities in the EEA

CountryNameContact details
AustriaAustrian Agency for Health and Food SafetySpargelfeldstraße 191
1220 Wien
Austria
Tel. +43 5 0555-0
Fax +43 5 0555-22019
www.ages.at
BelgiumFederal Agency for Medicines and Health ProductsEurostation 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/
BulgariaBulgarian Drug Agency8 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
CroatiaAgency for medicinal products and medical devices of CroatiaKsaverska cesta 4
10 000 Zagreb
Tel. +385 1 4884 100
Fax: +385 1 4884 110
E-mail: halmed@halmed.hr
www.halmed.hr
CyprusMinistry of Health – Pharmaceutical ServicesPharmaceutical 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
CzechiaState Institute for Drug ControlSrobárova 48
100 41 Praha 10
Czechia
Tel. +420 272 185 333
Fax +420 272 185 756
E-mail: infs@sukl.cz
www.sukl.cz
DenmarkDanish Medicines AgencyAxel Heides Gade 1
2300 København S
Denmark
Tel. +45 7222 7400
E-mail: dkma@dkma.dk
www.laegemiddelstyrelsen.dk
EstoniaState Agency of Medicines1 Nooruse Street
50411 Tartu
Estonia
Tel. +372 737 41 40
Fax +372 737 41 42
E-mail: info@ravimiamet.ee
www.ravimiamet.ee
FinlandFinnish Medicines AgencyP.O. Box 55
FI-00034 FIMEA
Finland
Tel. +358 29 522 3341
Fax +358 29 522 3002
www.fimea.fi
FranceNational Agency for the Safety of Medicine and Health Products143-147 bd Anatole France
93285 Saint Denis cedex
France
Tel. +33 1 55 87 30 00
www.ansm.sante.fr
GermanyFederal Institute for Drugs and Medical DevicesKurt-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
GermanyPaul Ehrlich InstitutePaul-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/
GreeceNational Organization for MedicinesMessogion Avenue 284
15562 Athens
Greece
Tel. +30 213 2040 200
Fax +30 210 6545 535
E-mail: relation@eof.gr
www.eof.gr
HungaryNational Institute of Pharmacy and NutritionZrínyi 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
IcelandIcelandic Medicines AgencyVínlandsleið 14
113 Reykjavík
Iceland
Tel. +354 520 2100
Fax +354 561 2170
E-mail: ima@ima.is
www.ima.is
IrelandHealth 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
ItalyItalian Medicines AgencyVia del Tritone, 181
00187 Roma
Italy
Tel. +39 06 5978401
Fax +39 06 59784312
www.aifa.gov.it
LatviaState Agency of Medicines15 Jersikas Street
1003 Riga
Latvia
Tel. +371 7078424
Fax +371 7078428
E-mail: info@zva.gov.lv
www.zva.gov.lv
LiechtensteinOffice of Health / Department of PharmaceuticalsÄulestr 512
9490 Vaduz
Liechtenstein
c
LithuaniaState Medicines Control AgencyŽirmūnų g. 139A
09120 Vilnius
Lithuania
Tel. +370 5 263 9264
Tel +370 5 263 9265
E-mail: vvkt@vvkt.lt
www.vvkt.lt
LuxembourgMinistry of HealthAllée Marconi
2120 Luxembourg
Luxembourg
E-mail: ministere-sante@ms.etat.lu
www.ms.etat.lu
MaltaMedicines AuthoritySir Temi Żammit Buildings
Malta Life Sciences Park
San Ġwann
SĠN 3000
Malta
Tel. +356 23439000
Fax +356 23439161
E-mail: info.medicinesauthority@gov.mt
www.medicinesauthority.gov.mt
NetherlandsMedicines Evaluation BoardGraadt van Roggenweg 500
3531 AH Utrecht
The Netherlands
Tel. +31 (0) 88 224 8000
Fax +31 (0) 88 224 8001
Contact: Submit your question
NetherlandsHealthcare InspectorateStadsplateau 1
3521 AZ Utrecht
The Netherlands
Tel. +31 88 120 5000
Fax +31 88 120 5001
E-mail: meldpunt@igz.nl
www.igz.nl
NorwayNorwegian Medicines AgencyPostboks 240 Skøyen
0213 Oslo
Norway
Tel. +47 22 89 77 00
E-mail:post@noma.no
https://legemiddelverket.no
PolandOffice for Registration of Medicinal Products, Medical Devices and Biocidal ProductsAl. Jerozolimskie 181C
02-222 Warsaw
Poland
Tel. +48 (22) 492 11 00
Fax +48 (22) 492 11 09
www.urpl.gov.pl
PolandChief Pharmaceutical InspectorateSenatorska 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
PortugalNational Authority of Medicines and Health ProductsParque 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
RomaniaNational Authority of Medicines and Medical DevicesStr. Aviator Sanatescu 48
011478 Bucharest
Romania
Tel. +4021 317 11 00
Fax +4021 316 34 97
www.anm.ro
SlovakiaState Institute for Drug ControlKvetná 11
825 08 Bratislava 26
Slovakia
Tel. +421 2 5070 1111
Fax +421 2 5556 4127
E-mail: sukl@sukl.sk
www.sukl.sk
SloveniaAgency for Medicinal Products and Medical Devices of the Republic of SloveniaSlovenčeva 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
SpainSpanish Agency for Medicines and Health ProductsParque Empresarial
Las Mercedes Edificio 8C/.
Campezo, 1
28022 Madrid
Spain
www.aemps.gob.es
SwedenMedical Products AgencyDag 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
SOURCE: European Medicines Agency

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