DocumentsDate added
These regulations shall apply to authorised medicinal products for human and veterinary use and any pharmacovigilance activity connected therewith. These regulations shall apply to but are not limited to pharmaceuticals, nutriceuticals, traditional, complementary and or alternative medicines, vaccines, biologicals and medical devices.
These regulations prescribe the minimum current good manufacturing practice requirements for manufacturing, processing, packaging or holding of a food or food product for human and animal use, to ensure that such food or food products meet the requirements of safety, quality, wholesomeness and suitability for consumption.
These regulations prescribe the minimum requirement for Good Laboratory Practice for conducting nonclinical studies for the purpose of obtaining marketing authorisation for all products regulated by the Agency including pharmaceuticals, cosmetic products, medical devices, food and feed additives,
pesticides, veterinary products, chemicals and similar products. The scope includes work conducted in the laboratory, in green houses and in the field.
These regulations prescribe the minimum requirements for good distribution practice in the public and private sectors for finished pharmaceutical products and shall apply to all persons and companies involved in any aspect of the distribution of pharmaceutical products from the manufacturing site to the point of use. These include but are not limited to governments at all levels, public and private health and storage facilities, manufacturers of finished pharmaceutical products, importers, exporters, distributors, wholesalers, suppliers, retailers, freighters, forwarding agents and transporters.
These regulations prescribe the minimum food safety requirements for preparation, processing, manufacturing, packaging, storing, transportation, distribution, handling and offering of food for sale or supply to the consumer.
These regulations prescribe the minimum current good manufacturing practice requirements for methods to be used in, and the facilities and controls to be used for, the manufacture, processing, packing, or holding of a medicinal product for human or animal use, to ensure that such medicinal product meets the requirements of safety, and has the identity and strength and meets the quality and purity characteristics that it purports or is represented to possess.