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.

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 — 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.

With the revocation of §§ 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.

Additional impacts of the new law:

1. GMP Certification for Pharmaceutical Ingredients — a point of contention likely to generate further discussion between the regulated sector and ANVISA: 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) may generate confusion, given that current regulations require GMP certification only for active pharmaceutical ingredients (APIs) in specific categories — namely synthetic and semi-synthetic APIs and biological ingredients. For certain classes — such as herbal medicines (fitoterápicos) — 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:

“RDC nº 1.004 de 2025

Art. 5º Para efeito do disposto nesta Resolução, existindo legislação ou guias específicos aplicáveis, estes também devem ser atendidos e as respectivas provas devem ser apresentadas.

• 1º Devem ser seguidas as Boas Práticas Agrícolas e de Colheita, as Boas Práticas de Processamento e Armazenamento e as Boas Práticas de Fabricação de insumos e de medicamentos na fabricação de fitoterápicos.
• 2º O solicitante do registro ou da notificação é responsável pela qualidade do IFAV utilizado na fabricação do medicamento.
• 3º Deve ser apresentada, no caso do registro, ou estar disponível na empresa, no caso da notificação, declaração assinada pelo responsável técnico da empresa fabricante do medicamento, ou pessoa por este designada, atestando que a fabricação do IFAV é conduzida de acordo com as Boas Práticas descritas no § 1º deste artigo.”

2. Registration of Pharmaceutical Ingredients — inconsistency with current terminology and legislation: the term registration of pharmaceutical ingredients is inconsistent with the regularization pathways established under current regulations. If the provision refers exclusively to active pharmaceutical ingredients (APIs), the existing regularization mechanisms are the Registration of ingredients (Cadastro de insumos), as per RDC No. 637/2022, and the CADIFA (Certificate of Adequacy of the Active Pharmaceutical Ingredient Dossier – Carta de Adequação do Dossiê de Insumo Farmacêutico Ativo), as set out in RDC No. 359/2020, which applies solely to synthetic and semi-synthetic APIs used in medicines covered by RDC No. 753/2022.

3. Revocation of previous provisions: § 1 allowed substitution of proof of registration in the country of origin with a document issued by the sanitary authority of the country of commercialization or by an international sanitary authority. § 2 required sworn translation and consularization of documents. Both ceased to exist.

4. Immediate entry into force: companies with ongoing registration processes or planned product launches may already include a justification of non-applicability of the CPP (Certificate of Pharmaceutical Product) in new registration submissions, while ANVISA updates the relevant resolutions.