ECUADOR

On April 21, the National Agency of Regulation, Control and Sanitary Surveillance (ARCSA, in Spanish) put out for public consultation the partial reform to the Technical Sanitary Regulation that establishes the guidelines for the control of the traceability of drugs, biological products and medical devices. This regulation establishes the codifications for the follow-up from the production or importation to the dispensing of these drugs. The public consultation has already been closed and Arcsa is expected to issue the new regulation in the short term. 

The document proposes that the suppliers of medicines of the Integrated Public Health Network (RPIS, in Spanish) have a period of up to 6 months, counted from the publication of the acquisition process of the Traceability Information System in the public procurement portal, to comply with the established guidelines. While the suppliers of the Complementary Private Network (RPC, in Spanish) and private pharmacies in the first phase of implementation of traceability, will have a period of up to 12 months to comply with the established provisions. 

Regarding abbreviations, the draft proposes that the two-dimensional codes will have a matrix structure formed by small squares or dots called modules that will be organized in a square mesh, which, unlike bar codes, will have the “advantage” of storing more information.