These Regulations provide rules on the registration and access to the market to medicine; licensing requirements for pharmaceutical operations, manufacturers, wholesalers and dispensaries; as well as on record-keeping, import of medicines, and clinical trials, etc.
Medicines and related substances Act
This Act provides for the registration, regulation of the sale, distribution, importation, exportation, manufacture and dispensing of medicines and related substances, and matters incidental thereto.
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.