Guidance for Regulatory Lot Release of Biological Products

This document is intended as a general guidance for application for regulalory lot release of biological products (vaccine and plasma derived medicinal products) marketed in Kenya whether manufactured in Kenya or imported.

The document has been developed in reference to WHO Guidelines for independent lot release of vaccines by regulatory authorities, accessible on (https://www.who.int/biologicals/WHO_ECBS/en/ and http://apps.who.int/medicinedocs/en . The Board shall reference the WHO guidelines in updating and implementing this guidance document in keeping with regulatory best practices.

Through the implementation of these guidance document in regulatory Lot release oversight, the Board shall achieve its function of ensuring that all vaccines and Plasma Derived Medicinal Products manufactured in, imported into or exported from Kenya conform to prescribed standards of quality safety and efficacy.

Applicants including manufacturers, Marketing authorization holders and importers are encouraged to acquaint themselves with this guidance and refer to the WHO guidelines when in doubt.