The diploma approves the rules of Procedure of the Ministry of Health.
The law modifies the articles 8, 135,137,139,159,160,166,195,204,226,244,250,275,292 and the title XII of the Constitution of the Republic of Mozambique.
Lei No 12/2017 Lei de medicamento, vacinas e outros produtos biológicos para o uso humano
This Law establishes the rules for the efficient and safe production, distribution, use and availability, as well as quality assurance of medicines, vaccines, biological and health products for citizens.
The resolution approves the Organic Statute of the Ministry of Health. It defines aspects as it competencies, functions, and the functions of it organs among other aspects.
The Diploma approves the Medicines Registration Manual. The purpose of the Manual is to (a) Standardize the procedures and activities relating to the registration of medicines; (b) Clarify the doubts that professionals have encountered when interpreting the Registration Regulations; (c) Support professionals in the field in carrying out their daily activities in a standardized way; (d) Support applicants in complying with registration and post-registration procedures; (e) to make the registration process an optimized and increasingly swift process.
This Regulation establishes the legal framework applicable to the contracting of public works, and the supply of goods and services to the State, including consultancy and concessions.
Constituição
The Constitution was promulgated in 2004 and modified in 2018. It includes 306 articles (17 titles) addressing a large number of issues as the protection of fundamental rights and freedoms, the fundamental principles of the state and institutional arrangements.
This Decree regulates the production, import, marketing and dispensing of medicines and one of its objectives is to ensure that medicines in the Republic of Mozambique are safe, effective, of good quality and meet the needs of the population.