ZMB- QA - GENERAL PROVISIONS
ANIMAL HEALTH
Zambia / Animal health
VETERINARY MEDICINAL PRODUCTS (VMPs)
GENERAL PROVISIONS
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2 answers
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2; Interpretations- "active pharmaceutical ingredient" means a substance intended to exert pharmacological activity or other direct effect in the diagnosis, treatment, cure, mitigation or prevention of disease or to affect the structure and function of the body, and may be used as in or in the manufacture of a pharmaceutical dosage form; "finished pharmaceutical product" means a product that has undergone all stages of production, including packaging in its final container and labelling; "general sale medicine veterinary (GSM)" means veterinary medicine which is intended to be supplied by any retailer approved by the Authority; "pharmacy medicine veterinary (PV)" means veterinary medicine which is intended to be supplied by a registered veterinary surgeon, pharmacist or veterinary para professional with or without a prescription; "veterinary medicine" means a substance or mixture of substances manufactured, sold or presented for use in- (a) the diagnosis, treatment, mitigation, cure or prevention of disease, disorder, abnormal physical or mental state or the symptoms thereof, in an animal; (b) restoring, correcting or beneficial modification of organic or mental functions in an animal; and (c) an article intended for use as a component of any article specified in paragraphs (a) and (b), but does not include a medical device or its component, part or accessory.
2; Interpretations- "medicinal product" means any substance or combination of substances which may be administered to human beings or animals in order to make a medical diagnosis or to restore, correct or modify the physiological functions in human beings or animals;
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5; Functions of the Authority [The Zambia Medicines Regulatory Authority] The Zambia Medicines Regulatory Authority is responsible for regulation and control of medicinal products.
9(2); the Expert Advisory Committee shall advise the Board of Authority on licensing of medicines and allied substances; on monitoring the advertisements on medicines and allied substances; on monitoring the standards relating to medicines and allied substances; and it shall provide technical and scientific advice on any aspect of medicines and allied substances; it shall review risk assessment and risk management measures relating to medicines and allied substances; it shall recommend containment measures, reporting mechanisms, remedial measures monitoring procedures and other appropriate conditions for medicines or allied substances.