This proposal sent by COFEPRIS on February 9, 2024, addresses the equivalence of requirements for health product registration, aiming to establish the criteria for importing medicines and medical devices without health registration, particularly in emergencies in Mexico. Additionally, it defines criteria for recognizing decisions made by Reference Regulatory Authorities and the World Health Organization's Prequalification Programme.
Update
This proposal can potentially nullify the previous provisions of the same agreement issued in January 2020 and June 2021. Its objective is to simplify granting health registrations by recognizing requirements from more reference regulatory authorities. Below are highlighted the most relevant points:
General criteria for the use and recognition of decisions from Reference Regulatory Authorities and the WHO Prequalification Program:
WHO's Reliance Good Practices will be adopted to recognize requirements equivalent to those established by the General Health Law.
Regulatory decisions will be based on risk analysis and evaluations from Reference Regulatory Authorities.
The Federal Commission for Protection against Sanitary Risks (COFEPRIS) has exclusive competence to decide on health registration requests, and decisions from Reference Regulatory Authorities are not binding.
Authorizations issued by Regulatory Authorities must undergo thorough and independent review.
Holders of health registration must request post-approval changes authorized by the reference regulatory authority.
Health products must have essential characteristics identical to those authorized by the reference regulatory authority.
Evaluation of health registration requests through an abbreviated regulatory pathway when requirements are met.
Criteria for Medical Devices:
Registration requests must include information and documentation to demonstrate quality, safety, and performance.
Health registration requests for importing drugs and medical devices without registration in Mexico, including a registration code in case of involving other reference regulatory authorities not covered in previous sections.
Provisions for importing health products without registration in Mexico:
Health registration requests for importation without registration in Mexico, if prequalified by the WHO or if they have valid marketing authorization or health registration issued by one of the National Regulatory Authorities designated by the WHO, without active health alerts. The holder must request health registration from COFEPRIS within 10 business days after importation for exclusive use in the health sector.
The Secretariat will determine supplies for emergencies related to emerging diseases, neglected tropical diseases, or national emergencies through the PAHO Strategic Fund. No health registration is required in Mexico for vaccines, medicines, and devices acquired by the Secretariat through appropriate mechanisms.
Requirements for importing health products without registration in Mexico:
Import requests for medical devices, under the code “COFEPRIS-01-014-A”, will reduce their legal term to one-third. COFEPRIS may take samples of imported products for analysis.
This Agreement will enter into force 60 business days after its publication in the Official Gazette of the Federation. It will issue provisions announcing the requirements for submitting requests referred to in Chapters II, III, and IV of this agreement.
It is worth mentioning that this proposal agreement is currently undergoing internal processes between the National Commission for Regulatory Improvement (CONAMER) and COFEPRIS and is in a public consultation period so that we will report progress towards the final version of the update.
Regulatory framework
Following the provisions established in the legal frameworks contained in the Organic Law of the Federal Public Administration, specifically in articles 39; the Federal Law of Administrative Procedure; the General Health Law; the General Law of Regulatory Improvement in its articles 4 and 69-C, 13, 17 bis, 194, 194 Bis, 204, 222 and 376; and the Health Supplies Regulation, specifically in its articles 2nd, 161 Bis, 166, 167, 169, 170, 177, 177 Bis 1, 177 Bis 2, 179, and 180. Additionally, the Internal Regulation of the Ministry of Health provisions are considered.
Effects from the RA update
The proposed update to the agreement will significantly affect the registration process for health products such as medicines and medical devices in Mexico. It streamlines the registration and importation process for these products without registration, facilitating access to safe and effective medicines and medical devices to address public health needs or emergencies. This regulatory framework aims to ensure the quality of imported products, expand their availability, and reduce associated costs. Additionally, it establishes specific requirements and codes for health registration applications, with defined maximum deadlines for COFEPRIS resolutions.
The proposal agreement is currently undergoing internal processes between the National Regulatory Improvement Council (CONAMER) and COFEPRIS and is in a public consultation period.
Written By:
Ana Carla Díaz
About ips
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