Vaccine Variation guideline

A Marketing Authorization Holder (MAH) of a registered vaccine is responsible for the quality, safety and efficacy of a registered vaccine and in this regard administrative, technical and scientific progress arising during the lifecycle of the vaccine should be taken into consideration by the MAH

Therefore, changes to a registered vaccine may be inevitable during its lifecycle and such changes may span from administrative to other substantial changes that enable a registered vaccine to be manufactured and controlled by methods which are scientifically relevant throughout its lifecycle.

The variation guideline is, therefore, intended to guide applicants on the conditions to fulfill and the type of documentation to provide before a proposed change can be approved. Three categories of changes that require an application for variation are described in the guidelines. The changes are Notification (N), Minor changes (Vmin), and Major changes (Vmaj).

A change is classified as major only in those instances where the level of risk is considered to be high, and it is deemed necessary to provide PPB with adequate time for an assessment of the supporting documentation. PPB shall make decisions on such changes. Where the proposed change has low risk and lower reporting requirements, it is classified as a notification or minor change.

Also, the guidelines assist in understanding the possible consequences of the listed changes and are useful as a risk management tool to promote best practices. The guidelines also enhance flexibility in approaches and therefore, alternate approaches to the principles and justified. Alternate approaches should be discussed in advance with PPB before implementation.

As a corollary to the above, it is equally important to note that PPB reserves the right to request information or material, or define conditions not explicitly described in this guideline, in order to allow for adequate assessment of proposed change in relation to quality, safety, and efficacy of a registered vaccine.

Applicants are urged to read and follow these guidelines fully so that applications for variations to registered vaccines meet submission requirements as outlined in these guidelines. Besides, comments are welcome for continuous improvement of these guidelines.