This Act provides for the establishment of a Namibia Medicines Regulatory Council; for the registration of medicines intended for human and for animal use; for the control of medicines and scheduled substances and provides for incidental matters.
This Act provides for the establishment of a Namibia Medicines Regulatory Council; for the registration of medicines intended for human and for animal use; for the control of medicines and scheduled substances and provides for incidental matters.
The Namibian Constitution was adopted in 1990 and amended in 1998, 2010 and 2014. The Constitution of Namibia is the supreme law of the country, it establishes state principles, defines the separation of powers in the state, defines rights and freedoms, etc. It consists of 148 articles that are grouped into 21 Chapters that are supplemented by 8 schedules.
This Act provides a framework for a structured uniform health system within Namibia; consolidates the laws relating to state hospitals and state health services, and regulates the conduct of state hospitals and state health services; provides for financial assistance for special medical treatment of State patients; and provides for incidental matters.
This Act amends the Medicines and Related Substances Control Act, 2003, so as to amend and delete certain definitions; provides for a period within which the Council must be appointed; provides for the appointment of chairpersons of committees established by the Council; amends provisions relating to the classification of medicines and other substances as scheduled substances; amends provisions relating to the manufacturing, packing and selling of specified Schedule 3 and specified Schedule 4 substances; deletes references to generic substitutions; substitutes references to Schedule 1, Schedule 2, Schedule 3 or Schedule 4 medicines by references to Schedule 1, Schedule 2, Schedule 3 or Schedule 4 substances; inserts provisions relating to the registration of premises engaged in the manufacturing of medicines; amends provisions relating to offences and penalties; amends provisions relating to the destruction of forfeited medicines, scheduled substances or other things; provides for the making of regulations in relation to medicines; amends provisions relating to the exclusion of medicines from the operation of the Act; amends the transitional provisions; amends provisions relating to the repeal and amendment of certain laws; and provides for matters incidental thereto.