SERVICES HUMAN SECTOR

Manufacturing and Distribution of food, drinks, parfums, beauty and cleansing products.

  1. Consulting advice for management and compliance with requirements and paperwork before COFEPRIS: Start of Operation Notice (Aviso de Funcionamiento), Import Permit, Free for-sale certificate (certificado de Libre Venta)
  2. Consulting for compliance with Good Manufacture and Distribution Practices and HACCP programs stablished by Mexico Official Rules.
  3. Good Manufacturing Practice Programs and Quality System audit under Mexico Official Rules and ISO standard.
  4. Design and Implementation for integral management systems under international standard (ISO 9001:2015, ISO 17025, ISO 17020, ISO 22000) and Mexico Official Rules.

Medication and Medical Devices, vaccines and biotechnology products.

  1. Complete strategies for develop, marketing, Pharmacovigilance and techno vigilance of medications, bioproducts, biotech products and medical devices.
    1. Clinical study for phase, bioequivalence test, Bio comparative and Biocompatibility trials.
    2. Lab Test couching
    3. Characterization study for bio comparison
    4. Product summit before the New Molecules Committee and the Biotech products Sub-committee at COFEPRIS.
    5. Conduct paper dossier integration for Sanitary Registration.
    6. Paperwork management for import and export, sanitary License, Good manufacture Practice certification.
    7. Development for Risks Management plan and Pharmacovigilance and techno vigilance surveillance plans.
  2. We have agreements and contracts with authorized third persons, research units and credited licensed labs with the best recognition.
  3. Conducting Good Practices audits for manufactures and distributors of drugs, medications and medical devices and the supply chain.
  4. Validation and qualification of pharmaceutical and medical devices factory plants.
  5. Design and implementation of integral management systems under international standards: ISO 9001:2015, ISO 17025, ISO 17020, ICH guidelines and Mexico Official Rules.

Plant nutrition, Pest control, and Toxic substances.

  1. Integral Strategies for Product Registration in Mexico.
    1. Lab Analysis.
    2. Paper Dossier compilation for Sanitary Register.
    3. Paperwork flown management for import and export of products and issue of Sanitary Licenses.
    4. We have agreements and contracts with authorized third persons, research units and credited licensed labs with the best recognition.
    5. Good Practices audits for manufactures and distributors.
    6. Design and implementing of Integral Management Systems under international standards; ISO 9001:2015 and Mexico Official Rules.

Health Clinics and Hospitals

  1. Couching, training and management for Credits and Certification for Hospitals and Clinics with Mexico Health Secretariat and Popular Insurance Program
  2. Paperwork Management before COFEPRIS: Sanitary Licenses
  3. Design and implementing integral management systems under international standards: ISO 9001:2015, ISO 17025, ISO 17020 and Mexico official rules.

FRECUENTLY ASKED QUESTIONS – HUMAN SECTOR.

  1. What activities and products are regulated under Mexico Sanitary Authority (COFEPRIS) because of having sanitary impact?
    • Health Facilities (Clinics, Hospitals)
    • Medications
    • Health Medical Devices
    • Disposing Human cells, tissues, organs and its components.
    • Food and Beverage.
    • Cosmetic Products (parfum and beauty items)
    • Cosmetic Products (parfum and beauty items)
    • Tobbaco
    • Pesticides, plant nutrients, toxic or Health hazardous substances.
    • Biotechnology products.
    • Food supplement.
    • Prevention and Control on harmful effects from environment factors affecting man, occupation and basic sanitation.
  2. What sanitary activities are regulated by State Governance?
  3. Only those related to food and drink selling.

  4. What are the Authorization or Licenses public must summit before COFEPRIS?
    • Sanitary License for locations.
    • Sanitary Registry for medications, medical devices, pesticides, plant nutrients and toxic substances.
    • Import and advertising Permits.
  5. What are the costs of such Authorizations from COFEPRIS?
  6. The amounts as payments are classified as ‘Derechos’ revised every year for updates under the federal laws.

  7. What types of facilities are required for Sanitary License in order to operate?
    • Medication and pharmaceuticals manufacturing plants.
    • Storage and distribution deposits for Medication Drugs type I y II (stupefacient or psychotropic substances).
    • Storage and distribution deposits for medication or biological products for human usage and biotechnology products.
    • Chemical, Biological, pharmaceutical or Toxicology reference control laboratory.
    • Facilities devoted to process veterinary usage medication drugs.
    • Plants manufacturing and blending pesticides and plant nutrient mixtures.
    • Clinics and hospitals.
  8. What products are required to obtain a sanitary registry from COFEPRIS prior going marketing process?
    • Drug medications, biological and biotechnology products, herb medications and remedies.
    • Medical devices.
    • Pesticides, plant nutrients and toxic substances.
  9. What products are considered medical devices?
  10. Medical equipment, prosthetics, orthotics, functional helpers, oral dent use articles, surgical materials and hygienic products.

  11. What other paperwork are needed before COFEPRIS beyond authorizations?
    • Good manufacture practice certifications (only for medications, drug, pharmaceuticals and medical device manufacturers).
    • Free-for-sale Certificates (for export).
    • Operation Notice for facilities not operating under a sanitary license (food manufacturers, parfum and beauty products manufacturers, cleansing products manufacturers).
    • Advertising adverts for such publicity not requiring a permit.
  12. What is the difference in an authorization with a Notice of Operation?
  13. Authorizations are subject to a resolution from COFEPRIS according to an stablished legal time frame and the notice is not, only is to present the completed paper form y wait for the seldom received advice stamp.

  14. What happens if my solicitude is rejected?
  15. Paperwork submissions can not be rejected as de facto, authorities are obligated to send an advice as notice to the applicant if is not in fulfillment for requirements or some information is missing and must give the applicant a legal time frame in order to fulfil and complete the required or missing information.

  16. Whose can present paperwork submission before COFEPRIS?
  17. Only Legal representatives for business and facilities, they must register as actives prior and before COFEPRIS.

  18. What are the must requirements in order to obtain a sanitary registry in Mexico?
    • For drug medications, herb remedy and Medical Devices as required in Federal regulation for Health supplies.
    • For pesticides, plant nutrients and toxic substances as required in the regulation on the matter of registry, authorization for import and export, Pesticide export certificates, plant nutrients and toxic o hazardous materials.
  19. Which and where are the solicited paperwork forms submitted before COFEPRIS?
  20. At ‘Centro Integral de Servicios’ located at Oklahoma 14, Col. Nápoles, Ciudad de México. C.P. 03810 by appointment only.Paperwork Forms are public published in ‘Diario Oficial’ (Mexico CFR) in the final resolution: “ACUERDO por el que se dan a conocer los trámites y servicios, así como los formatos que aplica la Secretaría de Salud, a través de la Comisión Federal para la Protección contra Riesgos Sanitarios, inscritos en el Registro Federal de Trámites y Servicios de la Comisión Federal de Mejora Regulatoria”. DOF-30/11/2018 1aSecc V p108.You can obtain all paperwork forms download from the COFEPRIS website or at ‘Centro Integral de Servicios’ directly.

  21. What is next for the facilities and products not requiring soliciting Authorization from COFEPRIS?
  22. Business are only to submit the corresponding Operation Notice Advise and obtaining the seldom received seal is enough. Such facilities can operate at once and products not requiring authorizations can be manufactured for sale.Very important to note is you must comply with rules and requisites as issued in all moments. COFEPRIS is entitled to show in a verifying visit at any time without notice.

News (Human)