Starting from 1 July 2023, all shipments containing pharmaceutical products from India to The Gambia, are required to undergo pre-shipment inspection as prevention measures for the falsified or substandard medicines entering Africa.
Quntrol Laboratories Private Limited has been appointed by the Medicines Control Agency (MCA) to conduct the inspection and provide a Clean Report of Inspection and Analysis (CRIA). The shipment that successfully completed all inspection procedures will receive a CRIA. If the shipment doesn't pass the inspection, no CRIA will be given and the shipment will be quarantined or seized by MCA.
Process Flow of Obtaining CRIA
Product Labelling Requirements
Labelling for primary or secondary container must be written clearly and legible in written in English
The generic name (applicable to the proprietary name of the medicine)
Dosage form and strength
The approved active ingredient names and the quantity (dosage unit)
The name of the active substance and genetically modified micro-organism or cell used in the manufacture (genetic engineering medicines)
The identification of the active ingredients by the Latin botanical name and common name (herbal medicinal products)
Excipients with recognized actions or effects by the Agency
The presentation and packaging size in proper unit or volume
Instruction for use
Method or route of administration of the products
Batch or lot numbers of the medicine
Expiry date of the manufacture
The name and address of the manufacturer and marketing authorization holder (MAH)
Storage instruction with specific reference in terms of temperature and precautions for the medicine
Cautionary warnings
Nutritional information
Sign of “for animal treatment only” or specific animals type applicable for veterinary medicines
Medicines registration number by the Agency
Specified warnings on the label as a condition of registration by the Agency