By KETRA KALUNGA
THE assessment and inspection reports on the AstraZeneca vaccine, was done way before the vaccines were received in the country, the Zambia Medicines Regulatory Authority (ZAMRA) has said.
ZAMRA senior public relations officer, Christabel Illiamupu, said the organisation used the World Health Organisation (WHO) Emergency Use Listing procedure to review vaccines and make recommendations to the Ministry of Health.
This follows concerns that ZAMRA did not have the vaccines tested when they arrived in the country but were rolled out immediately.
She assured that ZAMRA conducted the review of regulatory dossiers, assessment and inspection reports from WHO and other stringent regulatory authorities.
This, she said, was done based on the provisions of the law which give exemptions for marketing authorisation for the medicines that are imported or exported in response to a declared health emergency.
“Based on provisions under Paragraph (e), Subsection (4) of Section 39 of the Medicines and Allied Substances Act (no. 3) of 2013 which gives exemptions for requirements for marketing authorisation for medicines imported or exported in response to a declared health emergency,” she said.
Ms Illiamupu assured that the testing of the AstraZeneca vaccine was done way before the vaccines arrived in Zambia.
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