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Health Legislation

Health Legislation

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Ley No 3/2003 de Medicamentos

The scope of application of this Law includes: medicines and health products, as well as the actions of natural and legal persons involved in the production, marketing, prescription and dispensing of pharmaceutical and health products within the national territory. This document is published as a part of a compilation of laws and decrees and this Law is located on page 2 of the file.

Medicines and Related Substances Act 101 of 1965

The Act provides for the registration and control of medicines and related substances for human and animal use, establishes the Medicines Control Council, and outlines its powers and responsibilities. It includes provisions for the licensing of manufacturers, distributors, and dispensers, as well as measures to ensure the availability of affordable medicines. The Act also addresses the regulation of medicine pricing, generic substitution, labeling, and procedures for appeals and re-evaluation of registered medicines.

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