All pharmaceutical drugs imported into Guyana must be registered with the Government Analyst-Food and Drug Department (GA-FDD) and all labelling must be in English and outfitted with the relevant information.
The Department emphasised the requirement yesterday in an advisory directed to drug importers and the public.
Drug importers are being advised that all drugs imported into Guyana must be registered with the Department in compliance with a New Drug Registration requirement, Food and Drug Act Chap 34:03- Regulations 1977, Regulation 78, the advisory said.
It added that the Department is reliant on full drug assessment for safety, efficacy and quality from the listed reference authorities, such as the United States of America, Canada, United Kingdom and Australia and this is according to Food and Drug Regulations No. 10 of 1977 Cap. (34:03), Part III, Regulation 78: 2 (K). Characteristics of the drugs assessed are the Active Pharmaceutical Ingredient (A.P.I), Clinical trials, Bioavailability, Stability, Bioequivalence inter-alia.
In cases where UK, US, Canada and Australia compliance are not met, the advisory informed, the Department would be reliant on PAHO/WHO system of prequalification/ recommendation from recognised reference authorities via the Caribbean Regulatory System.
In addition, the brand and generic name, the address of the manufacturer and the patient information leaflet must be stated in English language on all finished product packages, the advisory said, before adding that this is prescribed for according to the Food and Drug Act.
“All drugs (prescription and over the counter) that are labeled in a foreign language will be seized and removed from premises,” the advisory said.
Consumers, on the other hand, are being advised to purchase prescription and over the counter medicines that are “adequately” labeled according to the Food and Drug Regulation 18, having a Brand and Generic Name, the list of ingredients, storage instructions, Expiry Date, the Address of Manufacturer, the Country of Origin and this information must be English Language.
