Importers and distributors of Pharmaceuticals, Cosmetic and Medical Devices are reminded to have their premises registered and licensed with the Government Analyst Food and Drug Department by March 31 of this year.

The reminder was issued by the Department last Tuesday.

Before licenses are issued, applications are required to be made on the prescribed forms and detailed inspections would be carried out to ensure that the operating conditions comply with the necessary requirements of the department. The requirements are as follows:

i. An importer of pharmaceutical, cosmetic or medical device products must provide premises with suitable conditions for the holding or storage of such products.

ii. The business of a pharmaceutical products importer should be under the control of a pharmacist.

The department conceded that where over-the-counter drugs only are being imported, a part time pharmacist is acceptable, but for the importation of third schedule of prescription medicines, the pharmacist must be employed on a full time basis. Similarly the business of drug wholesaler and distributor is also expected to be under the direct control of a pharmacist.

iii. Importers are required to have direct control over their distributors including the inspection of records, ensuring proper storage conditions and the various schedules of drugs are sold only to authorised dealers.

iv. It was also pointed out that the drug to be imported is listed by its generic name in the most recent publication of the Guyana National Formulary.

v. All drugs imported into the country must be registered with the department and should arrive with at least seventy-five percent of their shelf life. The information submitted in the registration process serves as a means of assessing the safety, quality and efficacy of pharmaceuticals.

vi. A Batch Certificate of Analysis must accompany each consignment of drugs imported. This serves as evidence that the drug as tested and conforms to specifications.

vii. Drug labels must be in English and must comply with other labeling requirements of the Food and Drugs Regulations, 1977.

viii. During transportation, drugs must be maintained at temperatures which would not adversely affect their shelf life or potency.

ix. All Import Licence Applications and Custom Entries of Pharmaceutical products must be approved or released by the department.

x. A permit will be issued for each consignment of Drugs imported into the country.

xi. Importers and distributors are required to maintain records of the receipt and issue of pharmaceuticals including their batch numbers. This allows for easy traceability of a batch of drugs. The importance of which is evident when it becomes necessary to recall a product from the market. Once the destination of a batch of a drug is known, it facilitates a speedy recall of the drug, which is often necessary, to prevent injury and even the death of customers.

xii. An importer of cosmetics would not be granted permission for the importation of cosmetics which are also drugs.

xiii. An importer of medical devices would be requested to produce a Certificate of Compliance from the Regulatory Authority in the country of origin of the devices.