Food and Drug Dept. says importation of ‘ COVID’ vaccines satisfied emergency use requirements
See below the full statement issued by the Government Analyst- Food and Drug Department (GA-FDD):
The Government Analyst – Food and Drug Department (GA-FDD) wishes to advise the general public that the importation and use of all COVID-19 vaccines followed all established emergency authorization – protocols for use during a pandemic.
The Department would have assessed all vaccines using WHO guidelines and were reliant on Emergency Use Authorization (EVA) issued by several serious reference authorities, inclusive of the United States Food and Drugs Administration (USFDA), the United Kingdom Medicine and Health Products Regulatory Agency (MHRA), the WHO Emergency Use listing. In addition, the Department relied on the Caribbean Public Health Agency’s (CARPHA-CRS) reference countries such as Brazil and Argentina for the approval of vaccines that were not approved by the other reference authorities.
Emergency Use Authorizations (EUA) were granted upon request as per protocol after receiving a request from the Maternal and Child Health Unit (MCHU), Ministry of Health, detailing the information of the vaccines that were intended to be imported, including the name and address of the manufacturer and supplier. Thereafter, the Department would have issued a EUL or waiver for importation, in addition to the issuance of an Import Permit with the name of specific manufacturer, the name of the supplier, the quantity and the name of the vaccine.
These approvals were all issued in accordance with the Laws of Guyana Food and Drug Act Cap 34:03 and its supporting Regulations 1977 – Regulation 86. The vaccines issued to date are:
No vaccine was imported into Guyana that did not satisfy the requirements of the Government Analyst Food and Drug Department for emergency use. On arrival of the vaccines into Guyana, the GA-FDD is informed that the MCH Unit of the Ministry of Health, verifies the Batch #, quantities and the manufacturer against the importation document received from the supplier.
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