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 at a 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 the ones which are prepared as per doctor’s prescription

  • Officinal Drugs: These are as per the Mexican Pharmacopoeia

  • Pharmaceutical Specialties: These are the ones prepared with formulas authorized by the Ministry of Health, in collaboration with the pharmaceutical industry

  • Further it is classified on based of 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 Pharmacopoeia of the United Mexican States for allopathic medicines

  • Herbal: Products made from 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 security has been scientifically confirmed in 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 the manufacturing procedures described in the Homeopathic Pharmacopoeia of the United Mexican States, in those of other countries or other national and international sources of scientific information



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 and can be filled up to two times, Medicines which 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 be sold anywhere other than pharmacies.


Product can be classified as New Molecule which could be:

· New drug substances (new in the world or new for Mexico)

· New combinations of drug substances (for Mexico)

· New indications


The process of registration with COFEPRIS starts with


Consultation Meeting with COFEPRIS New Molecules Committee (NMC):

  • A meeting request is submitted to the committee

  • The NMC reviews the request and share their decision within 60 days

  • NMC schedules meeting with applicant

  • Post meeting with the applicant and reviewing the presentation and documents shared by applicant, NMC issue technical opinion within 20 days

  • Applicant can submit the dossier upon receiving details from NMC


Request GMP inspection from COFEPRIS

  • GMP inspection must be requested to COFEPRIS as Mexico abides to their own CMP practices and standards

  • GMP certificates for other country of origin is exempted

  • GMP certificate is must for all the manufacturing sites


Checklist documents for GMP Inspection

1. Name and general information of the establishment

2. Name of the drug or medicine for which you are requesting verification of GMP

3. Name and full address of the establishment(s) involved in each stage of manufacturing

4. Description of the process that is carried out in each of the establishments involved

5. The manufacturing process for which verification of GMP is requested

6. A list and description of products that are made

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

8. Organization charts (general, of the production and quality departments, indicating the reporting lines)

9. Plans of the establishment and production areas

10. Block diagram of the manufacturing process

11. General summary of the quality system including validation and qualification

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 dossier to third party or directly to COFEPRIS for review and approval


Module I: Legal/Administrative Information:

  • 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 Information Required as per COFEPRIS
  • GMP certificate API manufacturing sites

  • GMP Certificate for Finished product manufacturing sites

  • Certificate of Pharmaceutical Product (This is applicable for drug manufactured outside Mexico)

  • Commercial name of products

  • Intellectual property/Patent Information

  • Information on the waiver for the local manufacturing facility requirement.


Module II: Quality Information

  • API: Manufacturing information, General Information, Quality Control (Literature/Pharmacopoeial references. Specifications. Analytical methods. Validation reports. Certificates of analysis (CoAs).

  • Excipients and additives: For new additives, usage safety information, Quality control ((Literature/Pharmacopoeial references. Specifications. Analytical methods. Validation reports. Certificates of analysis (CoAs).

  • Finished product: Pharmaceutical development, Formulation/Manufacturing information, in process controls, Quality control, Monographs specifications, Analytical methods certificates of analysis, Stability studies and stability data, Packaging materials (description and capacity)


Module III: Preclinical Studies (as applicable for new molecules, Vaccines and Orphan Drugs)

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

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


Registration Process for Foreign Manufacturer: The process would be different for organizations with prior registration in reference countries or without registration in reference countries


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

  • Request meeting with COFEPRIS New Molecule Committee (NMC)

  • Using 3rd party for evaluation of technical files

  • 3rd Party issues evaluated report to Manufacturer

  • Submit registration request to COFEPRIS


No Prior Registration in reference countries


  • Request GMP certificate in country of origin

  • Conduct clinical studies on Mexican Population

  • Request meeting with COFEPRIS New Molecule Committee (NMC)

  • Using 3rd party for evaluation of technical files

  • 3rd Party issues evaluated report to Manufacturer

  • Submit registration request to COFEPRIS


Timeline

The response time for New Molecules and Generics is anywhere around 180 days whereas requesting a meeting with COFEPRIS New Molecule committee takes around 60 days and another 20-40 days for receiving New Molecule committee conclusions after meeting.


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

  • Preparation and submission of dossier, complying to necessary guidelines to ensure a smooth process of submission for pharmaceutical products

  • We have a team of consultants who have experiences handling GMP audits for manufacturing sites updating system as per GMP requirements

  • Artixio team can partner as your authorized legal representative for Mexico helping with health authority (COFEPRIS) communication on a regular basis

  • We have our partners who can also assist you with local clinical and non-Clinical testing of your products at ISO compliant laboratories in Mexico


Our team would be happy to assist you with your requirements for Medicinal/Pharmaceutical Product registrations in Mexico.