The Federal Commission for Protection against Sanitary Risks (COFEPRIS), through an Agreement published in the Official Gazette of the Federation (DOF) on March 27, 2025, will simplify health supplies procedures. Starting 15 working days after publication, procedures for establishment operation notices (COFEPRIS-05-006) and modifications/cancellations (COFEPRIS-05-007) will be merged, and the requirement to submit the "Operation Notice, Sanitary Responsible, and Modification or Cancellation Notice" form and the "Original Responsible Notice, for the case of sanitary responsible cancellation" will be eliminated.
Update
In order to carry out actions to simplify procedures, on March 27, 2025, the Agreement that discloses the procedures that will no longer have to be submitted to the Federal Commission for Protection against Sanitary Risks (COFEPRIS) was published in the Official Gazette of the Federation (DOF).
Regulatory Framework
According to the provisions of the published Agreement, the presented modifications will come into effect 15 business days after its publication, so it is of utmost importance to consider the following changes:
For procedures related to establishments engaged in the manufacturing, storage, distribution, and points of sale of certain health supplies:
The procedures: COFEPRIS-05-006-A, COFEPRIS-05-006-B, COFEPRIS-05-006-C, COFEPRIS-05-006-D, and COFEPRIS-05-006-E, will be merged into the code COFEPRIS-05-006 “Notice of operation and sanitary responsible of health supplies establishments” and will include the following modalities:
A. Factory of Medical Devices or Herbal Remedies
B. Warehouse for Storage and/or Distribution of Medical Devices, or Herbal Remedies or Non-Controlled Medicines or Raw Materials for Non-Controlled Medicines
C. Drug Distributor (as Legal Representative in Mexico of a Foreign Company) D. Allopathic Pharmacy or Homeopathic Pharmacy (Without Preparation of Pharmaceutical Specialties) or Drugstore
E. Retail trade of Medical Devices or Herbal Remedies.
The procedures: COFEPRIS-05-007-A, COFEPRIS-05-007-B, COFEPRIS-05-007-C, COFEPRIS-05-007-D, and COFEPRIS-05-007-E, will be merged into the code COFEPRIS-05-007 “Notice of Modification or Cancellation of the Operation Notice and/or Sanitary Responsible of the Health Supplies Establishment” and will include the following modalities:
A. Factory of Medical Devices or Herbal Remedies
B. Warehouse for Storage and/or Distribution of Medical Devices, or Herbal Remedies or Non-Controlled Medicines or Raw Materials for Non-Controlled Medicines
C. Drug Distributor (as Legal Representative in Mexico of a Foreign Company)
D. Allopathic Pharmacy or Homeopathic Pharmacy (Without Preparation of Pharmaceutical Specialties) or Drugstore
E. Retail trade of Medical Devices or Herbal Remedies.
The requirement to submit the "Operation Notice, Sanitary Responsible, and Modification or Cancellation Notice" form is eliminated for the following procedures / codes and related modalities:
COFEPRIS-05-006 - Notice of operation and sanitary responsible of health supplies establishments.
COFEPRIS-05-007 - Notice of Modification or Cancellation of the Operation Notice and/or Sanitary Responsible of the Health Supplies Establishment. Additionally, the requirement to submit the “Notice of the original responsible, in the case of sanitary responsible cancellation” is eliminated.
Effects from the RA update
The simplification of the aforementioned procedures is in line with the regulatory improvement policy to streamline and modernize processes and services aimed at the digitization of procedures, seeking to obtain expeditious responses from the authority.
Written By:
Mariel Antonio
Israel Jiménez
About ips
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