Registration of the Medicine and API in the Country of Origin Is No Longer a Legal Requirement — On the Change in Parameters Introduced by Law No. 15,440/2026, Which Amends Law No. 6,360/1976
Law No. 15,440/2026 introduced a significant amendment to Law No. 6,360/1976, establishing certification of compliance with Good Manufacturing Practices (GMP) — as regulated by the competent health authority — as a requirement for the registration of medicines and pharmaceutical inputs, whether domestically or internationally manufactured.
Before:
Art. 18. The registration of drugs, medicines, and pharmaceutical inputs of foreign origin shall depend, in addition to the conditions, requirements, and procedures set forth in this Law and its regulations, on proof that the product is already registered in its country of origin.
§ 1. Where compliance with the provision set forth in the head paragraph of this article is not possible, proof of a registration in force must be submitted, issued by the health authority of the country where the product is marketed or by an international health authority, and approved by a specific act of the National Health Surveillance Agency (Anvisa) of the Ministry of Health.
§ 2. At the time of registration of a medicine of foreign origin, the manufacturing company must present proof of compliance with Good Manufacturing Practices recognized at the national level.
New wording following the amendment:
Art. 18. The registration of medicines and pharmaceutical inputs, whether of domestic or foreign manufacture, is subject to proof of Good Manufacturing Practices (GMP) certification, in accordance with regulations issued by the health authority.
§ 1 (Repealed).
§ 2 (Repealed).
With this new wording, the regulatory focus shifts expressly to proof of the production process’s compliance with Good Manufacturing Practices. In practice, this amendment reinforces, with the force of law, the centrality of GMP certification as an essential technical element for the sanitary review of registration in Brazil — for both products manufactured in Brazil and those from abroad.
The legal amendment is already in force. However, the details — particularly its impact on the sanitary registration procedure — will come with the regulatory rules to be issued by Anvisa, which must necessarily reflect the teleology (purpose) of this federal law amendment.
This amendment has a significant impact on companies operating in the pharmaceutical chain, especially manufacturers, importers, registration holders, and API suppliers.
This shift consolidates a paradigm change in Brazilian health surveillance, moving the regulatory axis from prior registration in the country of origin toward robust proof of Good Manufacturing Practices before Anvisa — aligning Brazil with the most recent international practices and reinforcing the technical responsibility of manufacturers and registration holders. It should also be noted that this legislative change aligns with a broader movement recognizing Anvisa as a regulatory agency of excellence, as has already been occurring in recent years.
This material is for informational purposes only and should not be used in isolation for decision-making. Specific legal advice may be provided by one of our attorneys. Copyright is reserved to KESTENER VIEIRA TORRONTEGUY SPEGIORIN ADVOGADOS.
