Mexico - Apply for Veterinary Product Registration

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Procedure

Apply In Person

1. To Apply for Veterinary Product Registration, the applicant has to approach the Federal Commission for the Protection against Sanitary Risks. link
2. An application form will be provided to the applicant by the concerned officer.
3. The applicant has to fill in all the necessary details in the application form. (Incomplete applications are not accepted)
4. Make sure that the applicant has attached all the necessary documents that are mentioned in the “Required Documents” section of this page.
5. The applicant has to attach the photocopies of the required documents along with the application form while submitting.
6. Submit all the documents with the completed form to the concerned officer.
7. The applicant has to pay the prescribed fee as requested by the authority.
8. 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.
9. Some products may require local testing in Mexico to support the registration application.
10. Then the application will be processed further. All the updates on the application status will be sent via SMS to the applicant’s mobile number.
11. Once the process gets completed, the applicant gets a call from the office regarding the application.
12. If the registration is approved, you will receive an authorization certificate. Keep up-to-date with post-approval requirements, including reporting adverse events, updates to the product information, and compliance with any post-marketing commitments.
13. Veterinary product registrations are typically valid for a specific period and may require renewal to remain on the market.
14. This entire process can be completed within 15 days or per the timeline the respective department authority advised.

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Required Documents

• Application form
• Identification documents (e.g., passport, national ID card).
• Proof of address (e.g., utility bills, lease agreement).
• Product technical information, including composition, formulation, and specifications.
• Preclinical and clinical trial data (if applicable).
• Manufacturing processes and quality control data.
• Stability data.
• Product labeling and packaging information.
• Information on potential adverse effects and safety measures.
• Proof of compliance with Good Manufacturing Practices (GMP) and other relevant standards.
• Any other documents (If required)

Office Locations & Contacts

Federal Commission for the Protection against Sanitary Risks.
Oklahoma 14 Col. Nápoles 03810 Mexico City
Telephone: 55 5080 5200
Citizen Service: 800 033 50 50
Email - [email protected]
Contact link

Eligibility

According to the Mexican Federal Commission for Protection against Sanitary Risks (COFEPRIS), the following are the eligibility requirements to apply for veterinary product registration in Mexico:

• The applicant must be a Mexican national or a foreign national with a legal residence in Mexico.
• The product must have been developed in Mexico or in a country that has a reciprocal sanitary agreement with Mexico.
• The product must be a veterinary medicinal product, a veterinary biological product, a veterinary diagnostic product, or a veterinary device.
• The product must meet the requirements of the Mexican Official Norms (NOMs) for veterinary products.

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 15 days or per the timeline the respective department authority advised.

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
• Surname
• Address
• ZIP code
• Date of Birth
• Gender
• Mobile number
• Fax
• Email
• Parents name
• Nationality
• Education details
• Mailing address
• Other details
• Declaration
• Date
• Signature

Need for the Document

• In Mexico, Veterinary Product Registration is a process overseen by the Federal Commission for the Protection against Sanitary Risks (Comisión Federal para la Protección contra Riesgos Sanitarios, COFEPRIS). It is a mandatory requirement for any company or individual wishing to market and sell veterinary products within the country.

Information which might help

• Veterinary products include a wide range of items, such as veterinary drugs, vaccines, nutritional supplements, pesticides for veterinary use, and other products intended for use in animals for medical or health-related 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

• The purpose of the Veterinary Product Registration is to ensure that these products meet specific safety, efficacy, and quality standards and that they do not pose a risk to the health of animals, humans, or the environment.
• By regulating these products, COFEPRIS aims to protect animal health, safeguard food safety, and promote responsible use of veterinary medications and treatments.