DMF Registration in Brazil for Active Pharmaceutical Ingredients (APIs)

Keywords: Anvisa DMF registration, DMF API registration in Brazil, DMF Anvisa.

In 2009, Brazil Health Authority, ANVISA, had introduced a regulation where all Active Pharmaceutical Ingredients (APIs), either manufactured locally or imported to Brazil and used in the manufacture of finished pharmaceutical products registered in Brazil must be?registered with ANVISA under a DMF. The regulation is applicable for synthetic APIs intended for use in drug products and not for APIs used for herbal medicines, biologics, vaccines or serum-based products.?

The regulation has been in implemented in different phases spread across the period of 2009 to 2016 for different APIs and since January 2016 onwards, only companies that have approved DMF/ASMF of APIs are eligible to import or commercialize their APIs or finished products with those APIs in Brazil. The only APIs exempted by Anvisa are the ones?intended for research and development of formulations.

Who can apply for DMF in Brazil?

A Brazilian company with National Register of Legal Entities number (CNPJ) can apply for DMF with ANVISA. The company shall be engaged in import, drug substance manufacturing or drug product manufacturing in Brazil.?

What is the content of DMF Registration with ANVISA?

The application for DMF must contain following documents for a single process. The documents shall be accepted in Portuguese, English and Spanish languages:

• properly filled petition form for ANVISA
• In case of health surveillance inspection, the original copy of receipt must be included in the application of the fee paid for inspection. In cases of exemption, the exemption probative document must be included.
• Sanitary permit, the Operation License, of the company duly updated must be provided.
• As applicable, copy of Operation Authorization or Special Operation Authorization to be submitted published in the Federal Official gazette.
• ?Copy of latest GMP Certificate issued by ANVISA as per Good Manufacturing Practices and Control of Pharmaceutical Ingredients required by ANVISA.
• ?In case GMP certificate issued by ANVISA is not available, an application requesting inspection by ANVISA must be provided or a probative document issued by local health authority satisfying the Operational Technical Conditions must be provided.
• A probative document with the record of API with Anvisa
• ?A Certificate of Technical Responsibility issued by Regional Council of Chemistry or Pharmacy related to the company applying for registration issue.
• Documentation on the control of the transmissible Spongiform Encephalopathy (TSE)?

What is the Validity Period of DMF in Brazil?

The DMF is valid for 5 years that can be reissued for equal and successive duration maintaining the initial record number of the DMF.?

Need Support Registering your DMF in Brazil?

GRP-Brazil is here to support.

Visit our website or send your inquiries directly to [email protected]