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:
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:
Cenral Drug Control Organization (CDSCO)
Directorate General Of Health Services
Ministry of Health & Family Welfare,
Government of India
FDA Bhawan, Kotla Marg, ITO,
Mandi House, New Delhi, Delhi, 110002,
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
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