In force since June 26, 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 approval document had been issued in a format incompatible with ANVISA requirements.

With the revocation of §§ 1st and 2nd of Art. 18, the Good Manufacturing Practices certificate (CBPF), already required by registration regulations for several medicines classes, is now also included 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 that would be likely to generate further discussion between the regulated sector and ANVISA: the new wording explicits that both medicines and pharmaceutical ingredients (broadly defined) depend on GMP certification to obtain or maintain registration. The term pharmaceutical ingredients (“insumos”) might have generated 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 Resolution 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.”

Free translation, provided for reference only; the original text in Portuguese shall prevail:
“RDC No. 1,004/2025
Art. 5. For the purposes of this Resolution, where specific applicable legislation or guides exist, these must also be complied with, and the corresponding supporting evidence must be submitted.
§ 1. Good Agricultural and Collection Practices, Good Processing and Storage Practices, and Good Manufacturing Practices for both active pharmaceutical ingredients and medicinal products must be followed in the manufacture of herbal medicinal products.
§ 2. The registration or notification applicant is responsible for the quality of the herbal active pharmaceutical ingredient (IFAV) used in the manufacture of the medicinal product.
§ 3. A statement signed by the technical director of the medicinal product’s manufacturing company, or a person designated by that individual, attesting that the manufacture of the IFAV is conducted in accordance with the Good Practices described in § 1 of this article, must be submitted in the case of registration, or be available at the company in the case of notification.”

Nevertheless, Law 15.440/2026 itself provides, in the new wording of Art. 18, that its application is contingent upon the terms of the regulation issued by the health authority. Thus, the manner of presenting proof or certification of GMP is expressly regulated by ANVISA’s infralegal instruments.

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.

As explained in the previous item, the application of the new wording of Art. 18 is contingent upon the regulations issued by the health authority. Thus, the terminology, as regulated by ANVISA’s infralegal instruments, remains valid.

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.

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) from the country of origin in new registration submissions, while ANVISA updates the relevant resolutions and checklists.