Anvisa’s Public Consultation No. 747 on the Normative Instruction (IN) draft that shall set terms and definitions to implement the National System for Drug Control (SNCM).
This measure seeks for the effective medicine security and, among others, the possibility to ensure product quality. William Dib, Anvisa’s director, stated “... In addition to ensure the origin of the medicines, the traceability may allow more effective actions to solve the problem arisen out of medicine quality or occasionally deviation and robbery”.
This matter has been discussed since the enactment of Law No. 11903, of January 14, 2009, that sets forth the traceability of production and consumption of medicines and creation of SNCM, but there was no definition on the boundaries and terms for the beginning of implementation of the system.
One must notice that the draft upon discussion sets, as the kick
up point for the system implementation, that companies shall, until
October 1, 2020, carry out the transmission of at least 25% of the
commercialized production in each establishment.
IN’s draft may be seen at this link.
Comments and suggestions submission to the text of the IN shall be made until January 3rd, 2020, at this link.
The content of this article is intended to provide a general guide to the subject matter. Specialist advice should be sought about your specific circumstances.