By MAIMBO MWEEMBA
The Zambia Medicines Regulatory Authority (ZAMRA) says in keeping with its mandate, the authority intercepted and destroyed a consignment of 10,000 doses of a suspected Covid- 19 vaccine imported into the country without authorization.
ZAMRA Public Relations officer Christabel Iliamupu said that on 2nd July 2021, the vaccine labelled as Hayat Vax [SARS-COV-2 Vaccine] (Vero Cell) inactivated, with batch number HV0025, was brought into the country by an importer named Chrismar Earthmoving Equipment.
Ms Iliamupu said that the consignment which was worth USD 150, 000 was seized at Kenneth Kaunda International Airport by ZAMRA in conjunction with the Zambia Revenue Authority.
She said the named vaccine is unauthorized for use on the Zambian market as it is not registered by ZAMRA.
“In addition, the vaccine is not under the World Health Organization (WHO) Emergency Use Listing (WHO EUL).The WHO EUL procedure is one of the regulatory reliance mechanisms which ZAMRA utilizes, like other national regulatory authorities in other jurisdictions, to consider Covid-19 vaccines for national use,” she said.
Ms Iliamupu said that according to the documentation which was furnished to ZAMRA, the purported manufacturer of Hayat Vax vaccine is Gulf Pharmaceutical Industries while the selling entity is G42 Medications Trading LLC of the United Arab Emirates (Middle East).
“It is required that in order to import Covid-19 vaccines one should have Pharmaceutical Licence, the Medicines and Allied Substances Act No.3 of 2013 requires such a person who intends to bring medicines into country to be a holder of a Pharmaceutical Licence, A Marketing Authorisation, prior to placing a medicine for use on the Zambian market, medicines, vaccines included, are required to be registered by ZAMRA in line with the said Act; an Import permit: A person who intends to import medicines is required to be in possession of an import permit issued by ZAMRA,” she said.
Ms Iliamupu said that the Authority has urged members of the public who intend to import Covid-19 vaccines, including other medicines and allied substances, for use on the Zambian market to ensure that the right processes and procedures are followed.
She said this is in accordance with the Medicines and Allied Substances Act No. 3 of 2013 and will help avoid stringent regulatory and legal action.
