ZAMRA Head Office , Lusaka
The Zambia Medicines Regulatory Authority formally the Pharmaceutical Regulatory Authority is a Statutory National Medicines Regulatory Body in Zambia established under an Act of Parliament, the Medicines and Allied Substances Act No. 3 of 2013 of the Laws of Zambia to regulate and control the Manufacture, Importation, Storage, Distribution, Supply, Sale and Use of Medicines and Allied Substances. The main objective of the Authority is to ensure that all Medicines and Allied Substances being made available to the Zambian people consistently meet the set standards of Quality, Safety and Efficacy.
The history of medicines regulation in Zambia dates back to 1941 when the Pharmacy and Poisons Act, Chapter 299 of the Laws of Zambia was first enacted. This Act was to provide for the control of the profession of pharmacy and trade in drugs and poisons.
OFFICE OF THE DIRECTOR GENERAL
The role of the Director General (DG) is to perform Policy setting and to ensure that there are effective linkages among and within departments, which will strengthen internal systems, controls, improve co-ordination and communication for effective performance of the Authority.
MEDICINES CONTROL
The Department is responsible for effectively managing the registration of products and undertaking of post marketing, post licensing surveillance and control of conduct of Clinical trials in order to achieve compliance to statutory regulations.
LABORATORY SERVICES
The Directorate of Laboratory Services is responsible for the effective providing of specialized Laboratory services in order to guarantee the quality, efficacy and safety of pharmaceutical products thereby safeguarding public health.
CORPORATE SERVICES
The Directorate of Corporate Services is responsible for managing the human, financial, administrative and logistical support services in order to enhance operations of the Authority. The Directorate is also responsible for providing Secretarial and legal services to the Authority in order to ensure compliance to the Medicines and Allied Substances Legislation.
