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Pharmaceutical Registration Process in Mexico (COFEPRIS)

Pharmaceutical Registration Process in Mexico (COFEPRIS)

Mexico is a major market in LATAM region. Pharmaceutical importation is expected to grow to $4.4 bn by 2024 ata CAGR of 2.2%. The regulations for Mexico are governed by COFEPRIS. It classifies drugs on the basis of preparation mode which categorizes drugs as:

  • Magisterial Drugs: These are theones which are prepared as perdoctor’s prescription

  • Officinal Drugs: These are as perthe Mexican Pharmacopoeia

  • Pharmaceutical Specialties:These are the ones preparedwith formulas authorized by theMinistry of Health, incollaboration with thepharmaceutical industry

  • Further it is classified on basedof origin:

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

  • Herbal: Products made from plant material or a derivative thereof, whose main ingredient isthe aerial or underground part ofa plant or extracts and tinctures, as well as juices, resins, fatty and essential oils, presented in pharmaceutical form, whose therapeutic efficacy and securityhas been scientifically confirmedin national or international literature.

  • Homeopathic: Any substance or mixture of substances of natural or synthetic origin that has a therapeutic, preventive or rehabilitative effect and that is prepared in accordance with themanufacturing procedures described in the Homeopathic Pharmacopoeia of the United Mexican States, in those of othercountries or other national and international sources of scientificinformation

The third classification is based upon the mode of delivery for products; it is further divided into six categories:

Medicine that needs prescription or special permission issued by MoH, Medicines which needs prescription and every sale should be recorded andcan be filled up to two times, Medicineswhich can be obtained only with prescriptions and can be filled up to three times, Medicines that requires prescriptions but can be refilled multiple times, Non-Prescription drugs for sale in pharmacies, Medicines that don’t require prescriptions and cane besold anywhere other than pharmacies.

Product can be classified as NewMolecule which could be:

  • New drug substances (new inthe world or new for Mexico)

  • New combinations of drugsubstances (for Mexico)

  • New indications

The process ofregistration withCOFEPRIS starts with Consultation Meeting withCOFEPRIS New MoleculesCommittee (NMC):

  • A meeting request is submittedto the committee

  • The NMC reviews the requestand share their decision within60 days

  • NMC schedules meeting withapplicant

  • Post meeting with the applicantand reviewing the presentationand documents shared byapplicant, NMC issue technicalopinion within 20 days

  • Applicant can submit the dossierupon receiving details from NMC

Request GMP inspection fromCOFEPRIS:

  • GMP inspection must berequested to COFEPRIS asMexico abides to their own CMPpractices and standards

  • GMP certificates for othercountry of origin is exempted

  • GMP certificate is must for all themanufacturing sites

Checklist documents for GMP Inspection:

1. Name and general information ofthe establishment

2. Name of the drug or medicine forwhich you are requesting verification ofGMP

3. Name and full address of theestablishment(s) involved in each stageof manufacturing

4. Description of the process that iscarried out in each of theestablishments involved

5. The manufacturing process forwhich verification of GMP is requested

6. A list and description of productsthat are made

7. Name of the legal representative,health officer or person designated bythe establishment to attend thediligence

8. Organization charts (general, ofthe production and qualitydepartments, indicating the reportinglines)

9. Plans of the establishment andproduction areas

10. Block diagram of themanufacturing process

11. General summary of the qualitysystem including validation andqualification

12. Information from the last two annual review reports, specifically indicating: manufactured lots, rejected lots (indicating reasons), released lots that were subject to investigation, conclusion and actions carried out, number of reprocessed batches, complaints, returns and withdrawal of products from the market, as well as conclusions of the report.

Prepare and Submit registration dossierto third party or directly to COFEPRISfor review and approval

Module I: Legal/AdministrativeInformation:

  • Application Form

  • Proof of Fee Payment of fee

  • Sanitary authorization (This is applicable for site located outside Mexico, one has to provide license, certificate or other document authorizing the site to the activities related to manufacturing of pharmaceutical products of interest, issued by the competent authority of the country of origin, legalized or apostilled, translated to Spanish by an official translator).

  • Responsible Sanitario notice

Labeling InformationRequired as perCOFEPRIS

  • GMP certificate APImanufacturing sites

  • GMP Certificate for Finishedproduct manufacturing sites

  • Certificate of PharmaceuticalProduct (This is applicable fordrug manufactured outsideMexico)

  • Commercial name of products

  • Intellectual property/PatentInformation

  • Information on the waiver for thelocal manufacturing facilityrequirement.

Module II: Quality Information

  • API: Manufacturing information,General Information, QualityControl(Literature/Pharmacopoeialreferences. Specifications.Analytical methods. Validationreports. Certificates of analysis(CoAs).

  • Excipients and additives: Fornew additives, usage safetyinformation, Quality control((Literature/Pharmacopoeialreferences. Specifications.Analytical methods. Validationreports. Certificates of analysis(CoAs).

  • Finished product:Pharmaceutical development,Formulation/Manufacturinginformation, in process controls,Quality control, Monographsspecifications, Analyticalmethods certificates of analysis,Stability studies and stabilitydata, Packaging materials(description and capacity)

Module III: Preclinical Studies (asapplicable for new molecules, Vaccinesand Orphan Drugs)

  • Preclinical studies:Pharmacodynamic studies,Pharmacokinetic studies,Toxicology studies

Module IV: Clinical Studies- Phase I,Phase II, Phase III and Phase IVstudies

Registration Process for ForeignManufacturer: The process would bedifferent for organizations with priorregistration in reference countries orwithout registration in referencecountries

Prior registration in referencecountries (USFDA, Health Canada,Swissmedic, EMA, TGA)

  • Request meeting withCOFEPRIS New MoleculeCommittee (NMC)

  • Using 3rd party for evaluation oftechnical files

  • 3rd Party issues evaluatedreport to Manufacturer

  • Submit registration request toCOFEPRIS

No Prior Registration in reference countries

  • Request GMP certificate incountry of origin

  • Conduct clinical studies onMexican Population

  • Request meeting withCOFEPRIS New MoleculeCommittee (NMC)

  • Using 3rd party for evaluation oftechnical files

  • 3rd Party issues evaluatedreport to Manufacturer

  • Submit registration request toCOFEPRIS


The response time for New Moleculesand Generics is anywhere around 180days whereas requesting a meetingwith COFEPRIS New Moleculecommittee takes around 60 days andanother 20-40 days for receiving NewMolecule committee conclusions aftermeeting.

At Artixio, we have a team of experts who understand the Mexican market and comes with decades of experienceworking with the authorities in Mexico. Our team has helped numerous pharmaceutical companies complying to COFEPRIS’s regulatory needs. Our experts have expertise in providing endto end solution for Mexican registration requirements:

  • Preparation and submission ofdossier, complying to necessaryguidelines to ensure a smoothprocess of submission forpharmaceutical products

  • We have a team of consultantswho have experiences handlingGMP audits for manufacturingsites updating system as perGMP requirements

  • Artixio team can partner as yourauthorized legal representativefor Mexico helping with healthauthority (COFEPRIS)communication on a regularbasis

  • We have our partners who canalso assist you with local clinicaland non-Clinical testing of yourproducts at ISO compliantlaboratories in Mexico

Our team would be happy to assist youwith your requirements forMedicinal/Pharmaceutical Productregistrations in Mexico.


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