BRAZILIAN DRUG TRACEABILITY REGULATORY UPDATES
Drug traceability has been the subject of debate in Brazil for more than a decade, but the country’s regulatory authority for the pharmaceutical industry, Anvisa, has reinforced the date of April 28, 2022, as the deadline to comply with track-and-trace regulations through the Instrução Normativa IN 100.
The Instrução Normativa IN 100 was published on August 23, 2021, establishing which drugs will need to comply, as well as the deadlines for serialization and communication with Anvisa’s new Drug Control System, called ‘Sistema Nacional de Controle de Medicamentos’ (SNCM).
Below, we seek to summarize the main points described in the new normative instructions for drug traceability.
WHAT INFORMATION SHOULD BE SENT TO THE NATIONAL DRUG CONTROL SYSTEM (SNCM)?
Normative Instruction No. 100 establishes that the following information must be provided to the SNCM:
- Registration of each drug
- GTIN number
- Serialized drugs
- Tracked drugs
- Anatomical Therapeutic Chemical (ATC) classification of the World Health Organization
- Regulatory classification
- Commercialization start date
WHAT DRUGS MUST BE SERIALIZED BY APRIL 2022?
All regularized drugs must be serialized for communication purposes to the National Drug Control System (SNCM) except for:
- Those exempt from prescription
- Specific, herbal and dynamic
- Injectable contrast media
- Medicinal gases
- Parenteral solutions above 50 ml
- Serums, vaccines and medicines with government destination
- Free samples