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Pharmacy and Medicines Regulatory Authority Act, 2019

Country/Territory
Malawi
Document type
Legislation
Date
2019
Source
FAO, FAOLEX
Subject
Livestock, Fisheries, General
Keyword
Drugs Institution Authorization/permit Internal trade International trade Registration Standards Public health Monitoring Risk assessment/management Use restrictions Research Offences/penalties International relations/cooperation Animal health Fish disease
Geographical area
Africa, Eastern Africa, Landlocked Developing Nations, Least Developed Countries
Abstract

This Act establishes an Authority known as the Pharmacy and Medicines Regulatory Authority. The Authority shall grant pharmaceutical licences and marketing authorizations; inspect any premises used for the purpose of manufacturing, distribution, sale, importation or exportation of medicines or allied substances or for any other purposes regulated under this Act; regulate and control the manufacture, importation, exportation, distribution and sale of medicines and allied substances and veterinary products; regulate and control the advertising and promotion of medicines and allied substances; register and regulate pharmacy practice premises and personnel and their training; in consultation with the relevant professional bodies, establish, maintain and develop standards for the operation of pharmacy practice premises and the pharmacy profession in general; serve and protect the public interest in all matters relating to the sale of medicines and allied substances; issue clinical trial licences; monitor the conduct of clinical trials; establish, maintain and enforce standards relating to the manufacture, importation, exportation, distribution and sale of medicines and allied substances; approve the use of unregistered and unauthorized medical products for trial or for compassionate use; establish a functional system for pre- and post-marketing surveillance of safety, quality, efficacy and effectiveness of medical products and to optimize the risk-benefit balance; establish, maintain and enforce standards for medicine quality control laboratories; formulate, disseminate, and advise the Minister on, policies relating to the regulation and control of medicines and allied substances; collaborate with corresponding medicines regulatory authorities in other countries; continuously review rules, regulations, guidelines and procedures pertaining to the implementation of this Act and make amendments where necessary in order to keep pace with changing times and pharmaceutical industry demands; in consultation with relevant research institutions, determine national priorities in pharmaceutical research; share data on pharmacy practice or medicine with other countries; and perform all such things as are connected with, or incidental to, the functions of the Authority under this Act. The Authority also may, upon application by a person, issue veterinary shop licence to the person to sell a prescribed list of veterinary medicinal products, under the control and management of such persons as the Authority may authorize. According to the Act, “medicine”, among others, means a substance or a mixture of substances used or purported to be suitable for use or manufactured or sold for use in the diagnosis, treatment, mitigation, modification or prevention of a disease, abnormal physical or mental state, or the symptoms thereof, in humans or in animals. The Act also provides for registration and regulation of pharmacists, pharmacy technologists, pharmacy assistants and medical representatives; registration and regulation of pharmacy practice premises; licences, import and export permits; regulation and registration of medicines and allied substances; regulation of clinical trials; the national medicines quality control laboratory; inspections; offences and penalties; and harmonization of regulation of medical products and international cooperation.

Full text
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