Functions depending on the source of vaccines

Of the six core functions introduced on the previous page, all NRAs are responsible for Function 1 (licensing vaccines) and Function 2 (AEFI surveillance). Both these functions should be coordinated with the National Immunization Programme.2, 54

The NRA can be responsible for Functions 3 – 6 depending on how its respective country obtains vaccines. Countries may:

  • Obtain vaccines through United Nations procurement agencies, i.e. United Nations Children's Fund (UNICEF), WHO, or Pan-American Health Organization (PAHO) Revolving Fund for Vaccine Procurement,
  • Procure vaccines directly on the domestic or the international market,
  • Manufacture their own vaccines.

The table below shows which responsibilities are taken up by the NRA depending on the source of the vaccine.

NRA functions depending on source of vaccines

Vaccine-specific NRA functions needed Areas of activity by NRA (or WHO) depending on source of vaccines
Vaccine procured by
United Nations agency
Vaccine procured by NRA Vaccine manufactured in country
FUNCTION 1
Marketing authorization and licensing activities
FUNCTION 2
AEFI surveillance
FUNCTION 3
NRA lot release
NRA functions undertaken by WHO on behalf of United Nations agencies or producing countries.
FUNCTION 4
Laboratory access
FUNCTION 5
Regulatory inspections
NRA functions undertaken by producing country.
FUNCTION 6
Oversight of clinical trials

The graphic below shows some of the key capabilities enabling a NRA to implement the 6 core functions listed in the table above.

NRA Key Capabilities