The mexican registration Holder (MRH) pays. The receipt must be included in the final dossier.

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If distributors will not be added to the registration at the time, they must be added later through a modification process.

All Mexican distributors are legally required to have these notices. An electronic copy of the notices is sufficient for the registration.

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Issuing authority to the legal representative in order to apply for renewals and/or registration submissions to COFEPRIS. And original or certified copy is required.

Simple copy of the document.

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Labels must be in Spanish, and should meet the requirements of the Mexican Labeling Norm NOM-137-SSA1-2008. Whenever Mexican Labels are not yet finalized and compliant, it is necessary to prepare and submit the Label Design.

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It must include: name, description of the product, intended use and directions of use, list of components or parts, assembly and disassembly (if applicable), operation and clean up instruction (if applicable), operation conditions and storing, warnings, cautions, contraindications and adverse events. For contrast media, indicate route of administration, pharmaceutical form and content of active ingredient per dose unit.

Report summarizing latest post marketing surveillance of the product. It include all adverse events recorded since the product was first made avaulable on the market (if applicable). It also includes the corective and preventive actions taken.

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This doesn't need to be submitted to COFEPRIS, but it needs to be kept on file by the Mexican Registration Holder.

Issued by the manufacturer, for any company to act as your Mexican Registration Holder. You will receive the template for the letter from the consultant during the dossier compilation process. Original or Certified copies are required.

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You will receive the template for the letter from the consultant during the dossier compilation process. Original or Certified copies are required.

Coded certificate issued within the last year, including the device to be registered before COFEPRIS. Original or Certified copy.

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It must include: description, intended of use, codes or presentations, formula and/or compositions, when applicable, shelf life when applicable, sterility period if applicable, primary and secondary packaging description. Original or Certified copy.

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It must include: description, intended of use, codes or presentations, formula and/or compositions, when applicable, shelf life when applicable, sterility period if applicable, primary and secondary packaging description. Original or Certified copy.

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