The purpose of this ordinance is to determine the rates and fees for regulatory services offered on drugs and other health products by the drug regulatory authority for Burundi (ABREMA).
The purpose of this ordinance is to organize the registration of medicines for human use and other pharmaceutical inputs in Burundi.
The law creates the Burundian Authority for the Regulation of Medicines for Human Use and Food. The authority's general aim is to protect public health by promoting the quality and safety of products such as prefabricated and ambient foods, medicines for human use, cosmetics and dietary products containing active ingredients, herbal medicines, traditional medicines, and medical devices, among others.
The decree provides for the organization and functioning of the Central Purchasing Center for Essential Medicines of Burundi [CAMEBU].
The legislation regulates the production, import, export, conservation, distribution, quality analysis and sale of medicines for human use, including traditional medicines, as well as all other health products, pharmaceutical practice and opticianry.
Namibia Essential Medicines List
The Namibia Essential Medicines List acts as a guide for the level of availability and use of essential medicines based on the skills levels of health workers as well as the availability of diagnostic facilities at the various levels of the Namibian public sector healthcare system.
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.
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.