Law No. 5,991, December 17, 1973 |
Ministry of Health |
Sanitary Control of Trade in Pharmaceuticals, Medicines, Pharmaceutical Inputs |
Pharmaceutical Industries, Pharmochemical Industries |
Regulates economic activity in the health sector |
Law No. 6,360, September 23, 1976 |
Ministry of Health |
Health Surveillance of Medicines, Pharmaceuticals, Pharmaceutical Inputs |
Pharmaceutical Industries, Pharmochemical Industries |
Regulates the performance of the productive sector for manufacturing safety |
Ordinance No. 802, October 8, 1998 |
Ministry of Health |
Sanitary control and supervision of the production, distribution, transport, and storage chain of pharmaceutical products |
Members of the production chain of pharmaceuticals |
Regulates the pharmaceutical manufacturing supply chain |
Ordinance No. 1.052, December 29, 1998 |
Ministry of Health |
Operating Authorization for companies transporting pharmaceuticals and pharmacochemicals |
Logistics Operators and Drug Transport Companies |
Regulates the participation in the health sector of companies that operate in the transport activity |
Resolution No. 329, July 22, 1999 |
Brazilian Health Surveillance Agency |
Inspection Roadmap for Medicines, Pharmaceuticals and Pharmaceutical Input Carriers |
Logistics Operators and Pharmaceutical Transport Companies |
Regulates the participation in the health sector of companies that operate in transportation |
Resolution No. 363, October 2, 2001 |
Federal Council of Pharmacy |
Regulates the activities of the pharmacist, in the storage of products in ports, airports, borders, and customs |
Pharmaceutical professionals and warehousing companies |
Controls professional category and storage activity in the import of critical inputs for health |
Resolution No. 433, April 26, 2005 |
Federal Council of Pharmacy |
Regulates the performance of the pharmacist in a land, air, rail or river transport company, of pharmaceuticals, pharmacochemicals |
Pharmaceutical professionals and transport companies |
Achieves the multimodality of transport activity for action in the health sector |
Law No. 11.903, January 14, 2009 |
Presidency of Brazil |
Tracking pharmaceutical production and consumption through electronic data capture and transmission technology |
Supply chain of medicines |
Logistics 4.0 interconnectivity of the logistics chain for data digitization |
RDC No. 54, December 10, 2013 |
Brazilian Health Surveillance Agency |
Implementation of the national drug control system to track the pharmaceutical chain |
Supply chain of medicines |
Logistics 4.0 in meeting the requirements of the national pharmaceutical control system |
Law No. 13.410, December 28, 2016 |
Presidency of Brazil |
Amends some articles of Law No. 11.903 to provide for the National Pharmaceutical Control System |
Supply chain of medicines |
Logistics 4.0 in meeting the requirements of the national pharmaceutical control system |
RDC No. 157, May 11, 2017 |
Brazilian Health Surveillance Agency |
Implementation of the National Pharmaceutical Control System |
Pharmaceutical Industries and other members of pharmaceutical production chain |
Assigns responsibilities to all members of the pharmaceutical production chain |
Normative Instruction No. 19, August 22, 2017 |
Brazilian Health Surveillance Agency |
Basic Technology Definitions for Pharmaceutical Chain Communication |
Pharmaceutical Industries and other members of pharmaceutical production chain |
Logistics 4.0 in meeting the requirements of the pharmaceutical distribution chain |
RDC No. 234, June 20, 2018 |
Brazilian Health Surveillance Agency |
Outsourcing of production steps, quality control, and logistics of medicines and biological products |
Pharmaceutical Industries and other companies operating in the drug production chain |
Guides the pharmaceutical production chain and transport and storage activities |
RDC No. 304, September 17th, 2019 |
Brazilian Health Surveillance Agency |
Good Practices for Distribution, Storage, and Transport of Medicines |
Logistics Operators |
Guides the entire pharmaceutical logistics operation |
Resolution No. 679, November 21, 2019 |
Federal council of Pharmacy |
Tasks of the pharmacist in foreign trade and multimodality of the transport of medicines and pharmaceutical supplies |
Professional category of pharmacists |
Guides professional category of pharmaceutical logistics |
RDC No. 360, March 27, 2020 |
Brazilian Health Surveillance Agency |
Good Practices for Distribution, Storage, and Transport of Medicines |
Logistics Operators working in the health sector |
Guides members of the pharmaceutical distribution chain regarding transportation |
RDC No. 430, October 8, 2020 |
Brazilian Health Surveillance Agency |
Provides for Good Practices for the Distribution, Storage, and Transport of Medicines |
Logistics Operators working in the health sector |
Guides the logistics operation. Relates to logistics 4.0 technologies |
RDC No. 658, March 30, 2022 |
Brazilian Health Surveillance Agency |
Provides for the General Guidelines for Good Manufacturing Practices for Medicines |
Pharmaceutical and pharmaceutical industries and other members of the production chain |
Establishes guidelines for the entire pharmaceuticals manufacturing production chain |