Brazil - Register Products for Veterinary Use of a Pharmaceutical Nature

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Procedure

Apply In Person

1. To Register Products for Veterinary Use of a Pharmaceutical Nature, the applicant has to approach the Ministry of Agriculture and Livestock link
2. Familiarize the applicant himself/herself with the requirements for registering veterinary pharmaceutical products. These requirements may include factors such as product safety, efficacy, quality, labelling, packaging, and compliance with relevant regulations and standards.
3. If the applicant is a foreign company or individual, it may be necessary to appoint a local representative or legal entity in Brazil to act on your behalf throughout the registration process.
4. An application form will be provided to the applicant by the concerned officer.
5. The applicant has to fill in all the necessary details in the application form. (Incomplete applications are not accepted)
6. Make sure that the applicant has attached all the necessary documents that are mentioned in the “Required Documents” section of this page.
7. The applicant has to attach photocopies of the required documents along with the application form while submitting it.
8. The applicant has to pay the prescribed fee as requested by the authority.
9. Submit all the documents with the completed form to the concerned officer.
10. After receiving the application, the concerned authority will check the submitted application and document set. If all are in place, the application will be accepted.
11. Then the application will be processed further.
12. The officer may conduct laboratory analysis or testing of the product. This is to verify compliance with the safety, efficacy, and quality standards set by the authority.
13. Once the application review and inspection process are complete, MAPA will make a decision regarding the certification.
14. If the application meets the necessary requirements and the applicant’s product is deemed safe, effective, and of appropriate quality, it will be granted registration.
15. The applicant will then receive a registration certificate or number for his/her veterinary pharmaceutical product, allowing him/her to legally market and sell it in Brazil.
16. This entire process can be completed within 30 days or as per the timeline advised by the respective department authority.

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Required Documents

• Application form
• ID proof (Birth Certificate, national Identity card, etc)
• Address proof – (Driving license, passbook, utility bill, etc)
• Product formulation and composition: Provide detailed information about the formulation, ingredients, and concentration of the product.
• Manufacturing and quality control data: Submit documentation related to the manufacturing process, quality control procedures, and specifications of the product.
• Safety and efficacy data: Include studies, clinical trials, or scientific evidence demonstrating the safety and efficacy of the product for its intended use.
• Labeling and packaging: Prepare the proposed label and package inserts, ensuring compliance with local regulations regarding product information, warnings, and usage instructions.
• Legal documentation: Provide proof of legal registration and authorization of the manufacturer or applicant, including business registration certificates and authorizations from relevant authorities in the applicant’s home country.
• Product samples: In some cases, product samples may be required for laboratory analysis or testing.
• Any other documents (if required)

Office Locations & Contacts

Ministry of Agriculture and Livestock
Esplanada dos Ministérios Bloco D - Brasilia, Federal District, 70043-900, Brazil
Esplanada dos Ministérios Bloco D - Brasília, DF, 70043-900
Phone - +556132182089
Contact link
Location link

Eligibility

• This typically includes being a family farmer or a cooperative/association of family farmers engaged in agricultural production.

Fees

• The applicant has to pay the prescribed fee as requested by the authority.

Validity

Explain the time until which the certificate/document is valid.
e.g. Birth Certificate Valid Forever

Documents to Use

Please attach documents that can be used by people. e.g. links

Sample Documents

Please attach sample completed documents that would help other people.

Processing Time

• This entire process can be completed within 30 days or as per the timeline advised by the respective department authority.

Related Videos

Videos explaining the procedure or to fill the applications.
Attach videos using the following tag <&video type='website'>video ID|width|height<&/video&> from external websites.
Please remove the '&' inside the tags during implementation.
Website = allocine, blip, dailymotion, facebook, gametrailers, googlevideo, html5, metacafe, myspace, revver,
sevenload, viddler, vimeo, youku, youtube
width = 560, height = 340, Video ID = Can be obtained from the URL of webpage where the video is displayed.
e.g In the following url 'http://www.youtube.com/watch?v=Y0US7oR_t3M' Video ID is 'Y0US7oR_t3M'.

Instructions

• Applicants must complete the application form before submitting it. Incomplete applications will not be accepted.
• Applicants must provide genuine information while applying for this procedure.

Required Information

• Name of the applicant
• Address of the applicant
• Age
• Plan
• Email ID
• Mobile number
• Fax
• Mailing address
• Nationality
• Declaration
• Date
• Signature

Need for the Document

• Products for veterinary use of a pharmaceutical nature in Brazil refer to pharmaceutical products specifically formulated and intended for use in animals for therapeutic, diagnostic, or preventive purposes.
• These products are designed to treat or prevent diseases, promote animal health, and improve the overall well-being of animals.

Information which might help

In Brazil, products for veterinary use of a pharmaceutical nature are regulated by the Ministry of Agriculture, Livestock and Supply (MAPA). These products include, but are not limited to, the following:

• Vaccines: Vaccines are used to prevent diseases in animals.
• Antibiotics: Antibiotics are used to treat bacterial infections in animals.
• Pain relievers: Pain relievers are used to relieve pain in animals.
• Antiparasitics: Antiparasitics are used to treat parasitic infections in animals.
• Other medications: Other medications, such as hormones and vitamins, may also be used for veterinary purposes.

Other uses of the Document/Certificate

Please explain what are other uses for obtaining this document/certificate.
e.g. Birth Certificate can be used as proof of identity.

External Links

Link

Others

• In order to be marketed in Brazil, products for veterinary use of a pharmaceutical nature must be registered with MAPA. The registration process includes a review of the product's safety and efficacy data. Once a product is registered, it must be labeled in accordance with Brazilian law.