Mexico - Obtain Sanitary Permit or License for the Import of Medicines with Sanitary Registration

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Procedure

Apply In-Person:

1. To Obtain Sanitary Permit or License for the Import of Medicines with Sanitary 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. Once the Sanitary Permit or License is approved, present the permit or license documentation to Mexican customs authorities during the importation process to facilitate customs clearance.
13. This entire process can be completed within 15 days or as per the timeline advised by the respective department authority.

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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 and specifications.
• Certificates of analysis, quality, or origin.
• Product labeling and packaging information.
• Proof of compliance with relevant standards and regulations.
• 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

The applicant is eligible to obtain a Sanitary Permit or License for the Import of Medicines with Sanitary Registration in Mexico if you meet the following requirements:

• You are a legal entity in Mexico.
• You have a physical address in Mexico.
• You have a responsible person who is a certified pharmacist.
• The medicines you are importing have a sanitary registration in Mexico.

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 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
• 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

• A Sanitary Permit or License for the Import of Medicines with Sanitary Registration in Mexico is a document that is issued by the Mexican Ministry of Health (Comisión Federal para la Protección contra Riesgos Sanitarios, COFEPRIS) that allows for the import of medicines that have a sanitary registration in Mexico. The permit ensures that the medicines are imported legally and that they meet the quality standards set by the COFEPRIS.

Information which might help

The following goods are not exempt from obtaining a Sanitary Permit or License prior to importing them into Mexico for samples or personal consumption:

• Food and beverages for commercial use: This includes items such as snacks, drinks, and candy that will be sold in Mexico.
• Cosmetics for commercial use: This includes items such as shampoo, soap, and toothpaste that will be sold in Mexico.
• Toiletries for commercial use: This includes items such as deodorant, toothpaste, and shaving cream that will be sold in Mexico.
• Household products for commercial use: This includes items such as cleaning supplies, laundry detergent, and dish soap that will be sold in Mexico.
• Pet products for commercial use: This includes items such as food, toys, and bedding that will be sold in Mexico.

Other uses of the Document/Certificate

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

External Links

link

Others

If you are importing goods for samples or personal consumption, it is important to note that you are limited to importing a certain quantity of goods. The maximum quantity of goods that you can import for samples or personal consumption is as follows:

• Food and beverages: 10 kilograms or liters per person.
• Cosmetics: 100 milliliters per person.
• Toiletries: 100 milliliters per person.
• Household products: 100 milliliters per person.
• Pet products: 100 milliliters per person.