Food and Drug department calls for compliance

Jan 29, 2010 News

The Government Analyst/Food and Drug Department, Ministry of Health, is reminding Importers and Distributors of Pharmaceuticals, Cosmetics and Medical Devices to have their premises registered/licensed with the Department by 31st March, 2010.
“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.”
According to the Department, the requirements to be satisfied for licensing include the following:
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 direct control of a Pharmacist. Where Over-the-Counter (OTC) drugs only are being imported, a Part-Time Pharmacist is acceptable, but for the importation of Third Schedule or Prescription medicines, the Pharmacist must be employed on a full-time basis. Similarly, the business of Drug Wholesaler/ Distributor should be under the direct control of a Pharmacist.
iii. Importers are required to have direct control over their distributors, including inspection of records, ensuring proper storage conditions and that the various schedules of drugs are sold to authorized dealers only.
iv. Importers should ensure that a drug to be imported is listed by its generic name in the most recent publication of the Guyana National Formulary.
v. Drugs imported into the country must be registered with the Department and should arrive with at least seventy-five percent (75%) 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 drug imported. This serves as evidence that the drug was 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 should be maintained at temperatures which would not adversely affect their shelf life/potency.
ix. All Import License Applications and Customs Entries of Pharmaceutical products must be approved or released by the Department.
x. A Permit will be issued for each consignment of drug 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 death of consumers.
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 Certificated of Compliance from the Regulatory Authority in the country of Origin of the devices.
The release concluded with the reminder that after the March 31, 2010 deadline, the Department would not process Import Permits for unregistered importers.

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Food and Drug department calls for compliance

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