Americas

Navigating the Regulatory Landscape: Central Hub for America's Regulations and Related Links

Global Regulations

Labelling

Products are required to display information in writing.

Lot Level Traceability

Products are traceable as part of uniquely identified lots.

Unit Level Traceability

Sellable units are uniquely identified enabling a more granular traceability.

Aggregation

The packaging hierarchy of products is required to be identified and documented.

Central repository

The traceability documentation is required to be centralized in a unique system.

All Regulations

US DSCSA

Navigate the intricacies of the Drug Supply Chain Security Act (DSCSA) with LSPedia. Our resource hub provides insights and updates, ensuring pharmaceutical companies stay compliant in the ever-evolving US regulatory environment.

Canada

In Canada, Health Canada serves as the central regulatory authority tasked with safeguarding public health through comprehensive oversight of pharmaceuticals. Canada's regulatory framework is anchored by the Drug Identification Number (DIN) system, which forms the backbone of the country's commitment to pharmaceutical traceability, safety, and quality assurance throughout the supply chain.

Regulations

Brazil Anvisa

In Brazil, the pharmaceutical landscape is underpinned by a commitment to ensuring the safety and authenticity of medicinal products. The Brazil National Agency of Sanitary Surveillance (ANVISA) has implemented stringent traceability requirements aimed at fortifying the pharmaceutical supply chain. These regulations are designed to combat counterfeit drugs, enhance patient safety, and provide regulatory authorities with improved visibility into the movement of pharmaceuticals throughout the distribution network.

Regulations
Currently no regulations

Argentina ANMAT

In Argentina, the National Administration of Food and Medical Technology (ANMAT) plays a pivotal role in safeguarding public health through robust regulatory measures. ANMAT's pharmaceutical traceability requirements stand as a cornerstone in the country's commitment to ensuring the authenticity and safety of medicinal products within the pharmaceutical supply chain.

Regulations

Columbia

In Colombia, the National Food and Drug Surveillance Institute (INVIMA - Instituto Nacional de Vigilancia de Medicamentos y Alimentos) serves as the cornerstone regulatory authority safeguarding public health through comprehensive pharmaceutical oversight. Colombia's track and trace regulations represent the nation's commitment to pharmaceutical security, ensuring product authenticity and patient safety throughout the entire supply chain from manufacturing to patient administration.

Regulations
Currently no regulations

No Regulations Found

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