Brazil: New norms for control and registration of medication and correlated products

Brazil announced new norms for the control and registration of medication and correlated products. What Swiss companies need to know.
A woman is checking an injection system.
New regulations in Brazil for the control and registration of medical products.

The promulgation of the Laws n. 13.410/2016 and 13.411/2016 that defines new norms for control and registrations of medication were published on the 28th of December of 2016.

What is new?

According to the Law n. 13.410/2016 art. 3, all medication registered shall receive specific identification based on storage and transmission of data, which must contain, among others, the following information:

  • register medication number at the competent office of the national health surveillance agency (ANVISA)

  • single medication serial number

  • medication batch number

  • medication expiration date.

It is also accounted as infraction the establishment that doesn’t communicate any information concerning distribution of the medication.

Registration deadline varies

Regarding the medical registration (Law 13.411/2016), the general rule contemplated by art. 12, Law n. 6.360/76 remains intact, therefore the deadline to grant the registration prevails 90 days after the protocol requirement. However, the arts. 17-A and 24-A of the new norm displays that the limit period for registry concessions can be modified according to the technical complexity and clinical, economic and social benefits associated with the medication aiming requirement.

Based on those criteria (complexity and benefits), two registry order evaluation categories where created: priority and ordinary. The first provides that there shall be 120 days for the registry process final decision deadline. The ordinary category shall have 365 days counting after the respective protocol emission date.

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Source: Trigueiro Fontes Advocacy


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