Medical devices, OTC drugs, cosmetics importers need Free Sale/Health Certificates – GA-FDD
All importers of Over-The-Counter (OTC) drugs, medical devices and cosmetics will now be required to have a valid Free Sale Certificate/Health Certificate to accompany their products whether importing for use or sale on the local market.
This is according to Director of the Government Analyst Food and Drug Department (GA-FDD), Dr Marlan Cole.
The GA-FDD Head said in a statement on Friday that original copies of the Free Sale Certificate or Health Certificate issued by the National Regulatory Authority of the country of origin of the products must be presented to the Department to facilitate importation.
The enforcement of this requirement will be effective from October 30, 2020.
This, he explained, is in keeping with the Laws of Guyana Chapter 34:03, and its supporting Regulations No 10 of 1977 which states that:
“Except as provided by the regulations, no article of Cosmetic, Over-The-Counter Drug and Medical Device shall be imported into Guyana unless the article wholly conforms to the Laws of the country in which it was manufactured or produced and is accompanied by a certificate in the prescribed form and manner that the article does not contravene any known requirement of the law of that country and that its sale therein would not constitute a contravention of the law thereof.”
According to the GA-FDD Director, submissions to the Department after the enforcement date that lack the necessary corresponding original Free Sale/Health Certificates will not be processed or result in entries being refused.
“The mandate of the GA-FDD is to protect consumers from unsafe or substandard products. A Free Sale Certificate or Health Certificate gives assurance that the products being imported are produced and/or manufactured under safe and sanitary conditions and are subjected to a degree of regulatory oversight in the country of origin. This further attests to a standard of safety, purity, and efficacy for use,” the statement from the Department Head detailed.
Meanwhile, the GA-FDD Director is urging importers to take cognisance of this notice and ensure that cosmetics, medical devices, and OTCs are accompanied by the requisite documentation by the stipulated deadline to avoid any negative repercussions.
Those who may have further questions, the GA-FDD is asking that they make contact with the Department on telephone numbers 222-8857 and 222-8859.