Conditions for Acceptance of an Application
An application for prequalification of a candidate vaccine will be accepted for evaluation only if the following conditions are met:
- the candidate vaccine is on the current vaccines prequalification priority list
- the candidate vaccine meets the mandatory characteristics for programmatic suitability
- the national regulatory authority (NRA) responsible for the regulatory oversight of the product must be a classified as a functional NRA or WHO-listed authority operating at maturity level 3 (at a minimum)
- a marketing authorization has been granted by the relevant NRA and post-marketing regulatory oversight is guaranteed by a responsible NRA (or NRAs).
Vaccine manufacturers who wish to submit a vaccine for prequalification must check with their respective NRA that it has been assessed by WHO and is considered to be functional for a vaccine-exporting country, or assessed and determined to meet the requirements of an NRA operating at maturity level 3 (at a minimum).
In addition, manufacturers are encouraged to discuss the product and the regulatory requirements with the vaccines assessment group of the WHO Prequalification Team before submission of a an application for evaluation.
Australia
National regulatory authority:
Therapeutic Goods Administration (TGA)
Department of Health and Ageing
P.O. Box 100
Woden, ACT 2606
Australia
Street address: 136 Narrabundah Lane
Symonston, Act 2609
Australia
National control laboratory:
Therapeutic Goods Administration Laboratories (TGAL)
Department of Health and Ageing
P.O. Box 100
Woden, ACT 2606
Australia
Belgium
National regulatory authority:
Federal Agency for Medicines and Healthcare Products (FAHMP)
Place Victor Horta 40/40
Bischoffsheimlaan 33
1060 Brussels
Belgium
National control laboratory:
Scientific Institute of Public Health
Federal Public Service of Public Health
Food Chain Safety and Environment
J. Wytsmansstraat 14
1050 Brussels
Belgium
Brazil
National regulatory authority:
Agencia Nacional da Vigilancia Sanitaria (ANVISA)
Esplanada dos Ministerios, Bloco G, 9o andar, sala 900
cep: 70058-900 Brasilia DF
Brazil
National control laboratory:
Instituto Nacional de Controle de Qualidade Saude (INCQS)
Ministerio da Saude
Avenida Brasil, 4365
Manguinhos
Cep: 21045-000, Rio de Janeiro, RJ
Brazil
Bulgaria
National regulatory authority:
Bulgarian Drug Agency
26 Yanko Sakazov Blvd
1504 Sofia
Bulgaria
National control laboratory:
Head, BCG Laboratory
National Center of Infectious and Parasitic Diseases
26, Yanko Sakazov Boulevard
1504 Sofia
Bulgaria
Canada
National regulatory authority:
Biologics and Genetic Therapies Directorate Health Canada
HPB Building #7 (Locator 0702)
Tunney's Pasture
Ottawa
Ontario K1A0L2
Canada
China
National regulatory authority:
China Food and Drug Administration (CFDA)
26 Xuanwumen Xidajie
Beijing 100053
People's Republic of China
National control laboratory:
National Institutes of Food and Drug Control
2 Tiantan Xi Li
Beijing 100050
People's Republic of China
Cuba
National regulatory authority/national control laboratory: CHECK CORRECT TO REFER TO THEM LIKE THIS
Centro para el Control Estatal de la Calidad de los Medicamentos (CECMED)
Ministerio de Salud Publica
Ave. 17 No. 20005, entre 200 y 202
Rpto Siboney, Playa
Apartado Postal 16066
CP-11600 Ciudad Habana
Cuba
Denmark
National regulatory authority:
Danish Medecines Agency
Axel heides Gade 1
2300 Kobenhavn 5
Denmark
France
National regulatory authority:
Agence nationale de sécurité du medicament et des produits du santé (ANSM)
Direction de l'Inspection et des Etablissements
143-147 boulevard Anatole France
93285 Saint Denis Cedex
France
National control laboratory:
Agence du Médicament
Direction des Laboratoires et des Contrôles, Unité de Contrôle des Médicaments Immunologiques
321 Avenue Jean Jaurès
69007 Lyon
France
Germany
National control laboratory:
Paul-Ehrlich-Institut (PEI)
Federal Agency for Sera and Vaccines
Paul Ehrlich Strasse 51-59
Postfach 1740
D-63225 Langen
Germany
Hungary
National regulatory authority:
National Institute of Pharmacy
Zrinyi utca 3
1051 Budapest
Hungary
National control laboratory:
General Director
Johan Béla National Center for Epidemiology
H-1097 Budapest Gyáli út 2-6
Hungary
India
National regulatory authority:
Drugs Controller General of India (DCGI) OUT OF DATE???????????
Directorate General of Health Services
Ministry of Health and Family Welfare
Nirman Bhawan, New Delhi 110 011
Government of India
India
National control laboratory:
Central Drugs Laboratory (CDL)
Central Research Institute
Kasauli
173 204 Himachal Pradesh
India
Indonesia
National regulatory authority:
Directorate General of Drug and Food Control
Ministry of Health
Jalan Percetakan Negara 23
Jakarta Pusat 10560
Indonesia
National control laboratory:
National Quality Control Laboratory of Drug and Food (NQCLDF)
Jalan Percetakan Negara 23
Jakarta 10560
Indonesia
Italy
National regulatory authority:
Agencia Italiana del Fármaco (AIFA)
Via Sierra Nevada 60 - 00144
Roma
Italy
National control laboratory:
Director
National Center for Immunobiologicals Research and Evaluation (CRIVIB)
Instituto Superiore di SanitàViale Regina Elena, 299
00161 Roma
Italy
Japan
National regulatory authority:
Pharmaceutical and Medical Safety Bureau
Ministry of Health, Labour and Welfare
1-2-2 Chome, Kasumigaseki
Chiyoda-ku, Tokyo 100-8916
Japan
National control laboratory:
National Institute of Infectious Diseases (NIID)
1-23-1 Toyama Shinjuku-Ku
Tokyo 162
Japan
Netherlands
National regulatory authority:
Medecines Evaluation Board (MEB)
PO Box 16229
2500 BE The Hague
The Netherlands
National control laboratory:
Center of Biological Medicines and Medical Technology
National Institute for Public Health and the Environment (RIVM/BMT)
PO Box 1
3720 BA Bilthoven
The Netherlands
Republic of Korea
National regulatory authority:
Office for Health and Medical Care Policy
Pharmaceutical Policy Team
Ministry of Health and Welfare
Anyang Construction Tower 10F
1112-1, Daran-dong
Dongan-Gu, Anyang-Si 431-811
Gyeonggi-do
Republic of Korea
National control laboratory:
The Ministry of Food and Drug Safety (MFDS)
Osong Health Technology Administration Complex
Osong-eup
Cheongwon-gun
Chungcheongbuk-do 363-700
Republic of Korea
Russian Federation
National regulatory authority:
Federal Service on Surveillance in Healthcare (Roszdravnadzor)
Slavyanskaya Square, 4, bld. 1
Moscow
Russian Federation
Senegal
National regulatory authority:
Direction de la Pharmacie et du Médicament (DPM)
Ministère de la Santé publique
153 rue Mousse Diop
B.P. 6150, Dakar
Senegal
National control laboratory:
Laboratoire National de Contrôle des Médicaments (LNCM)
Senegal
ADDRESS??????
Sweden
National regulatory authority:
Medical Products Agency
P.O. Box 26
SE-751 03 Uppsala
Sweden
Switzerland
Swissmedic
Swiss Agency for Therapeutic Products
Hallerstrasse 7
CH-3000 Bern 9
Switzerland
United States of America
National regulatory authority:
US Food and Drug Administration (FDA)
Center for Biologics Evaluation and Research (CBER)
1401 Rockville Pike
Rockville, MD 20852
USA