Brazil opens public comment on traceability proposals

The healthcare regulator in Brazil - ANVISA - published its proposals for medicines traceability today and has opened a 30-day public comment period.

The Public Consultation No. 10/2013 establishes the 2D datamatrix code as the primary carrier for the capture, storage and transmission of electronic data to trace medicines through the supply chain in Brazil.

It also suggests that responsibility for implementing the traceability scheme will be shared equally between all stakeholders in the "chain of production, distribution and consumption" of medicinal products.

According the proposals companies holding product registrations will be responsible for generating and placing a unique drug identifier (IUM) on secondary medicine packs, based on its 13-digit ANVISA registration number, plus a serial number, expiration date and lot number. The code - which will also have to be present on hospital packs - should be present in both datamatrix and human-readable form.

As expected, earlier plans to require printing of the codes onto security labels printed by the national mint have been dropped and no longer appear in the specifications document, and the system appears to be much closer to other serialisation initiatives, including Turkey's ITS and the medicine verification scheme proposed for the EU by the European Federation of Pharmaceutical Industry Associations (EFPIA) in Sweden.
 
ANVISA is accepting comments on the document between April 10 and May 9, and responses will be published on its website. After the comment period a public meeting will be held later in May to discuss the technical requirements and develop a finalised version.