Health Legislation

The Resolution approved the Treaty Establishing the African Medicines Agency, adopted in February 2019 by the 32nd Ordinary Session of the Assembly of Heads of State and Government of the African Union, held in Addis Ababa – Ethiopia. 

This decree regulates the exercise of hospital pharmaceutical activity in the health structures of the National Health Service. It covers all health structures of the National Health Service that carry out this activity, namely central hospitals and regional hospitals. Its purpose is to organize, improve, optimize and standardize hospital pharmaceutical services in the National Health Service.

The purpose of these Regulations is to establish the organizational and operating rules of the National Medicines Council, a body provided for in the Organic Chart of the Ministry of Health, approved by Decree-Law no. 56/2021 of 21 September, which establishes the structure and operating rules of the Ministry of Health.

This decree creates the Independent Health Regulatory Authority, defining its attributions, organization and functioning. The status of the organization are in annex to this Decree.

The decree provides the National List of Essential Medicines.

This decree regulates the marketing authorization, registration, manufacture, import, export, marketing, donations and advertising of medicines for human use.

The Constitution was promulgated by the Lei constitucional No 1/IV/92, de 25 de setembro. It includes 293 articles addressing a wide array of issues including among other things fundamental rights and duties, the fundamental principles of the Republic and institutional arrangements.