Sanitary Registration of Medicines

In order to market a drug in Mexico, it is necessary to have a sanitary authorization for the product, the name of such authorization is called SANITARY REGISTRY.

LEGAL BASIS:

Medications , narcotics, psychotropic substances and products that contain them require health registration; medical equipment, prostheses, orthotics, functional aids, diagnostic agents, dental supplies, surgical and healing materials and hygienic products, the latter in the terms of section VI of article 262 of this Law, as well as pesticides, nutrients vegetables and toxic or dangerous substances.

CLASSIFICATION OF DRUGS:

ACCORDING TO THE PREPARATION:

Magisterial : When they are prepared according to the formula prescribed by a doctor  

 

II. Office : When the preparation is carried out according to the rules of the Pharmacopoeia of the United Mexican States  

 

III. Pharmaceutical specialties : When they are prepared with formulas authorized by the Ministry of Health, in establishments of the chemical-pharmaceutical industry.

ACCORDING TO NATURE:

Allopathic: Any substance or mixture of substances of natural or synthetic origin that has therapeutic, preventive or rehabilitative effect, that is presented in pharmaceutical form and is identified as such by its pharmacological activity, physical, chemical and biological characteristics, and is registered in the Pharmacopoeia of the United Mexican States for allopathic drugs

 

II. Homeopathic: Any substance or mixture of substances of natural or synthetic origin that has therapeutic, preventive or rehabilitative effect and that is prepared in accordance with the manufacturing procedures described in the Homeopathic Pharmacopoeia of the United Mexican States, in those of other countries or other sources of national and international scientific information

 

III. Herbalists: Products made with plant material or a derivative thereof, whose main ingredient is the aerial or underground part of a plant or extracts and tinctures, as well as juices, resins, fatty and essential oils, presented in pharmaceutical form, whose therapeutic efficacy and safety has been scientifically confirmed in the national or international literature.

PROCEDURES WITH WHICH REGULATE CAN SUPPORT YOU

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ADVISORY

Allopathic, vitamin and herbal medicines

  • Do you want to market your product and have no idea where to start?

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ASSEMBLY OF DOSSIER

Medicine, herbal remedy and specialized enteral formula

  • Do you want to enter a sanitary registration request or alphanumeric code for your project but you have no idea about its characteristics  format and you even have a question about administrative documentation?

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DOSSIER VALIDATION

Allopathic and vitamin medicine

  • You have already assembled your dossier, but do you want us to review the format and content prior to submitting it to COFEPRIS?

  • Our experts have worked in COFEPRIS and authorized third parties, so you will have an effective validation.

TYPES OF DOSSIER IN WHICH REGULATE CAN SUPPORT YOU

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New records

Allopathic, vitamin and herbal medicines

  • Allopathic: New or generic molecule.

  • Vitaminic

  • Herbalist

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Extensions

Allopathic, vitamin and herbal medicines

  • Extension of validity

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Modifications

Allopathic, vitamin and herbal medicines

Administrative  

  • Cession of rights

  • Change in name of holder

  • Distinctive denomination

  • Distributor