Register your product for animal use or consumption (Biologicals, pharmaceuticals: injectables, premixes, orals, soluble powders, ectoparacitides; diagnostic kits, homeopathic, biotechnological, autogenous biologicals) for free commercialization in Mexico for 5 years. Applies to products for animal use or consumption included in Section I - VII of Article 151 of the regulations of the Federal Animal Health Law that are to be imported and marketed in national territory. Comply with Articles 91, 92, 93, 94 and 95 of the Federal Animal Health Law and Articles 149, 150, 153, 154, 155, 156, 157, 158, 159, 160 of the Regulations of the Federal Animal Health Law.
Services Included: The entire process from import to approved registration; import authorization letter for samples for verification with payment of duties $704.00, import process by CVM (includes permits), import advice; customs declaration, customs clearance, storage payment, customs clearance, maneuvers, etc., payment to customs agent, payment of import zoosanitary certificate ($10,000.00); verification process, sending samples, review of results, payment to official laboratory ($10,000.00); Preparation of forms, payment of duties for $1,638.00 pesos, document review, submission of the procedure to SADER - SENASICA, settlement of warnings, sending of originals, packaging and session of registration fees to designated distributor and payment of duties ($934.00).
Processing time: maximum 12 months.
Deliverable: Approved document, card and label with SADER health registration number (Includes all necessary costs for importing samples and products).
Recommendation: If you have any questions regarding the legislation applicable to your product, we recommend requesting the service (Evaluation and classification of veterinary products; SRV0074) to determine whether it requires Registration, Authorization, or is Deregulated.
Essential requirements: GMP Certificate, Free Sale Certificate, and Distribution Authorization duly legalized, in addition to stability tests.
Questions and support prior to payment: regulatory@cvmexico.com.mx Tel. 378 121 10 60.
Requirements: Once you have made payment for your application, you must send the following requirements in (pdf) format to tramites@cvmexico.com.mx:
- File (Dossier) in PDF format.
- Billing information (company name, RFC, address, email, telephone number and contact information of the manufacturer and registrant).
- Address for receiving documents.
Within 24 hours, a specialist will be in touch to support you throughout the process.
IMPORTATION, VERIFICATION AND REGISTRATION OF PHARMACEUTICALS
Within 24 hours of making the payment for the procedure and receiving your documents by email, we will follow these steps:
1.- A specialist will contact you by phone to provide instructions and support throughout the process.
2.- An analyst will review the documents received and, if necessary, request additional documents or information.
3.- Your application will be submitted to SADER - SENASICA.
4.- Once the process is complete, the registration documents or the SADER - SENASICA resolution will be sent to your address via DHL.
Processing time: maximum 12 months.

