Regulatory Policies

The pharmaceutical business in Zambia is regulated by the Pharmaceutical Act No. 14 of 2004. The Act establishes the Pharmaceutical Regulatory Authority (PRA) which is responsible for registration and regulation of pharmacies; registration and regulation of medicines, herbal medicines and allied substances intended for human use and for animal use; regulation and control of the manufacture, importation, exportation, possession, storage, distribution, supply, promotion, sale and use of medicines, herbal medicines and allied substances. The key functions to achieve this include the registration of medicinal products, inspections of facilities and products, licensing of pharmaceutical premises (retail, wholesalers, and manufacturing sites) and issuing of import and export licenses and permits. However, the Act does not regulate the practice of pharmacy professionals. Pharmaceutical staffs are registered under another piece of legislation[1].

The legislation is inadequate, however. For example, 14 applicable acts were enacted more than 50 years ago, and some are irrelevant to current health sector dynamics. Additionally, most new policies and legislation are still in draft form. The lack of an act to provide a framework for the organization of health services has created a situation where the health sector operates in a legislative vacuum. Linked to that is the lack of a framework to monitor and evaluate the impacts of new policies and legislation[2].

Policy Glances from Macro Guidelines to Micro Rules

1)      National Health Policy 2012: The new National Health Policy for Zambia was developed within the context of the Vision 2030 and has taken into consideration other relevant national, regional and global health related policies, protocols and strategic frameworks, including the Millennium Development Goals (MDGs). The policy shall be implemented through successive National Development Plans and National Health Strategic Plans.

2)      National Health Strategic Plan 2011-2015 (NHSP): The NHSP defines the scope, priorities and overall direction of the sector wide cooperation during a five-year period. All support and cooperation in the health sector shall be guided by the NHSP and, to this end, a Memorandum of Understanding (MoU) on adhering to this plan in implementing projects and programs is to be signed between all stakeholders involved in health, including donors[3].

3)      The National Health Strategic Plan 2011-2015: It recognizes that in order to ensure optimal availability, appropriateness, distribution and conditions of essential infrastructure, facilitating equity of access to essential health services, there is need inter alia to promote private sector participation, including PPPs[4].

Registration Policies

Registration of pharmaceutical products for use on the Zambian market is done by the PRA through the directorate of Product Registration. The directorate further submits evaluation reports to the Medicines Committee for consideration before inclusion of products on the register. The formation of medicines committee is provided for under section 9 in the Pharmaceutical Act No. 14 of 2004.

[1] Disclosure Status of Pharmaceutical Sector Data: Zambia, The Medicines Transparency Alliance Zambia (WHO Harvard Collaborating Center in Pharmaceutical Policy), June 2010, pp.6-7.

[2] Gustaf Engstrand, Report on the Health Care Sector and Business Opportunities in Zambia, p.22.

[3] Ibid., p.25.

[4] Gustaf Engstrand, Report on the Health Care Sector and Business Opportunities in Zambia, p.48.