NORMATIVE INSTRUCTION IN 100: BRAZIL’S NEW DRUG TRACEABILITY REGULATION
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
WHAT IS THE SERIALIZATION PLAN THAT MUST BE DELIVERED TO ANVISA?
Anvisa expects to receive a serialization plan (from registration holders) that provides acquisition, qualification, validation and logistical integration of equipment information, as well as the serialization solutions for all the drugs that must comply.
This serialization plan must:
- Cover all production lines, drugs and deadlines
- Be formally documented and approved by the Pharmaceutical Quality Management System and ratified by the company’s management
- Be permanently updated and adequate according to its execution
- Have information and data on the drugs, sites, production lines and steps involved
- Be made available, via the SNCM portal, within 30 days after the platform is made available
- Have partial percentages until the complete serialization of product production lines
Note that the SNCM portal has not yet been made available and there is no official indication as to when it might be.
WHAT IS THE DEADLINE FOR IMPLEMENTING DRUG TRACEABILITY IN BRAZIL?
According to the Normative Instruction, all supply chain stakeholders must communicate all records of events related to movement of serialized drugs starting April 28, 2022.
NEXT STEPS FOR IMPLEMENTING DRUG TRACEABILITY
For over 30 years, OPTEL has been developing and implementing traceability solutions for companies that need to comply with regulatory requirements and want more transparency and quality. Based on this background, we recommend the following five steps to start a drug traceability project:
- First, it is important to bring staff together from the different departments within your organization that will be impacted by a traceability project (engineering, IT, production, logistics, marketing, etc.).
- Once you have defined the team that will help guide the project, establish which packaging lines will need to be equipped with both serialization and aggregation solutions.
- Next, gather line layouts/blueprints that show the physical space constraints and other relevant production information so that a rough solution can be sketched out.
- Invite suppliers for a technical visit and to draft a solution.
- This information exchange will provide guidance to develop the User Requirements Specification (URS), an important step to determine the capabilities a solution needs to meet compliance requirements and to fit your company.