Source: Anvisa (12/12/2011)

In order to proceed with the measures adopted within the scope of Anvisa in compliance with the provisions of Law No. 11.903 / 2009, which provides for the tracking of the production and consumption of medicines by means of electronic data capture, storage and transmission technology, Anvisa's Collegiate Board decided on the guidelines that will guide the implementation of the National Medicines Control System - SNCM.

These guidelines result from the consolidation of the analysis carried out in an interinstitutional working group, composed of representatives from the Ministry of Health, Ministry of Justice, Ministry of Development, Industry and Foreign Trade and the Agency itself, in alignment with the principles and objectives of public access policies medicines, which are also prioritized within the scope of the Council of Ministers of the Medicines Market Regulation Chamber - CMED, and are basically available as follows:

1. The basis of the SNCM is based on the application of the DRUG TRACEABILITY concept, in line with legal dictates.

2. Use of the two-dimensional code Datamatrix as a data carrier technology.

3. Use of the Unique Medicines Identifier - IUM, consisting of an individual, non-repetitive, 13-digit number to be represented on the packaging encoded in the Datamatrix and also presented in legible numeric characters. The unique drug identifier will be generated and managed by Anvisa, through a system integrated with SNCM.

4. Adoption of the content standard for the two-dimensional code Datamatrix, basically composed of: registration number, batch, validity and IUM.

5. Obligation to maintain its own database and carry out movement and stock control by means of a computerized system compatible with the specifications and capture standards established by Anvisa, on the part of both the companies with registration with Anvisa and the distribution companies retail trade.

6. Secondary packaging of all drugs must contain identification and security mechanisms that enable traceability from manufacture to the moment of dispensing. The cases of multiple, hospital and fractionable packaging will be the object of more in-depth studies, in order to verify the possibility of guaranteeing the traceability of the medicine to the final consumer.

7. Responsibility of the companies holding the registration for the affixing of the two-dimensional Datamatrix code on the packaging of medicines to be marketed in Brazilian territory. The choice of the modality for affixing the Datamatrix to the packaging is at the discretion of the companies holding the registration, and must be processed in strict compliance with the applicable technical standards.

8. Questions related to readers of authenticity, in the manner previously provided, are no longer applicable.

9. Central data capture, storage and management system established at the government level and managed by Anvisa.

10. Review of RDC No. 59/2009 and / or elaboration of the relevant regulations.

11. Definition and dissemination of mechanisms to be used to consult the origin of the medication directly by the consumer.

Anvisa will adopt the necessary measures and referrals for the establishment of the technical, operational and operational definitions of the National Medicines Control System and other resulting administrative measures.