The Brazilian National Health Surveillance Agency (Anvisa), has just made a manual available with explanations about Regulatory Instruction No. 100, which deals with the Serialization Plan for the National System for Drug Control (SNCM). The plan, which will be mandatory throughout the pharmaceutical chain as of 2021, will start to be implemented this October, as foreseen by Anvisa. The SNCM Processing Guide is a clarification document, not regulatory, of a non-binding nature, aimed at informing and clarifying any doubts regarding existing procedures. Therefore, it is not intended to broaden or restrict any technical requirements.
According to Anvisa’s directorate, the manual aims to guide the user through the Serialization Plan module of the National Drug Control System. According to Regulatory Instruction No. 100, of August 23, 2021, the registration holders must submit acquisition schedules, qualifications, verification, and logistical integration of the equipment and serialization solutions for all production lines, as well as updating the existing ones until there is complete serialization of the lines within their Serialization Plan. To achieve this, the SNCM-Plan enables the registration holders to submit and update their Serialization Plan as defined in the regulation, as well as allowing Anvisa to monitor progress and identify any potential issues with implementing traceability.
According to the manual presented by Anvisa, the SNCM-Plan must be used by the Registration Holder’s headquarters, i.e., there are no requirements to submit individualized plans for each production center. It is up to the parent company to prepare a plan in which information from all production plants is entered, including those located abroad or that are outsourced.
Seeking to maintain smoothness and transparency of the entire process, those responsible for the companies are given the opportunity to access detailed information about the documents and information required. It is also possible to access a step-by-step guide with orientation on how to use the platform.