{"id":1122,"date":"2026-07-02T10:12:42","date_gmt":"2026-07-02T13:12:42","guid":{"rendered":"https:\/\/www.vitapharmaconsulting.com\/en\/?post_type=noticias&p=1122"},"modified":"2026-07-05T19:53:19","modified_gmt":"2026-07-05T22:53:19","slug":"law-no-15440-2026","status":"publish","type":"noticias","link":"https:\/\/www.vitapharmaconsulting.com\/en\/news\/2026\/07\/02\/law-no-15440-2026\/","title":{"rendered":"Law No. 15,440\/2026: proof of registration in the country of origin is no longer a legal requirement for registering medicines in Brazil."},"content":{"rendered":"

In force since June 29, 2026, the new wording of Art. 18 of Law No. 6,360\/1976 introduces a relevant change for the registration of imported medicines at ANVISA.<\/span><\/p>\n

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The requirement to present proof of registration in the country of origin has historically been one of the main friction points in applications by foreign companies \u2014 particularly when the product was still in the global launch phase or the local registration had been issued in a format incompatible with ANVISA requirements.<\/span><\/p>\n

With the revocation of \u00a7\u00a7 1 and 2 of Art. 18, the Good Manufacturing Practice certificate (CBPF), already required by registration regulations for several medicine classes, is now also enshrined in the law itself. ANVISA may still regulate additional requirements through infralegal instruments, but the statutory provision that allowed a registration to be blocked for lack of proof of foreign registration no longer exists.<\/span><\/p>\n

Additional impacts of the new law:<\/h3>\n

1. GMP Certification for Pharmaceutical Ingredients \u2014 a point of contention likely to generate further discussion between the regulated sector and ANVISA:<\/strong> the new wording makes explicit that both medicines and pharmaceutical ingredients (broadly defined) depend on GMP certification to obtain or maintain registration. The term pharmaceutical ingredients (insumos)<\/em> may generate confusion, given that current regulations require GMP certification only for active pharmaceutical ingredients (APIs) in specific categories \u2014 namely synthetic and semi-synthetic APIs and biological ingredients. For certain classes \u2014 such as herbal medicines (fitoter\u00e1picos)<\/em> \u2014 the applicable regulation explicitly requires only compliance with Good Manufacturing Practices, not the GMP certificate itself, in recognition of the particular realities of that sector. A case in point is RDC No. 1,004\/2025, which governs herbal medicinal products<\/span>:<\/span><\/p>\n

“<\/span>RDC n\u00ba 1.004 de 2025<\/b><\/p>\n

Art. 5\u00ba Para efeito do disposto nesta Resolu\u00e7\u00e3o, existindo legisla\u00e7\u00e3o ou guias espec\u00edficos aplic\u00e1veis, estes tamb\u00e9m devem ser atendidos e as respectivas provas devem ser apresentadas.<\/span><\/p>\n