Mexico Profile Updated

The Mexico profile in ClinRegs has been reviewed and updated with the most current requirements. Key updates include: 

• New pharmacovigilance reporting guidelines providing procedures required to prepare reports and extend sanitary registrations for drug products (See Safety Reporting and Manufacturing & Import)
• Decree amending sanitary registration requirements for biosimilar biotechnological drug products including COFEPRIS’s acceptance of data produced abroad for foreign manufactured products (See Scope of Assessment)
• Updated fee information to submit requests for research protocol amendments or modifications and observational studies (See Regulatory Fees)

Sources Added During this Update:

(Regulation) Decree Amending, Adding and Repealing Various Provisions of the Regulation of Health Products (Reg-HlthProdAmd - Spanish) (Effective June 1, 2021)
Ministry of Health

(Guidance) Pharmacovigilance Guide for the Preparation of the Periodic Safety Report (G-PharmPerSafRpt) (February 10, 2021)
Federal Commission for the Protection Against Sanitary Risks (COFEPRIS), Ministry of Health

(Guidance) Guidelines for Requesting the Pharmacovigilance Report (G-PharmRptReq - Spanish) (May 3, 2021)
Federal Commission for the Protection Against Sanitary Risks (COFEPRIS), Ministry of Health

(Article) Mexico: Major Change to the Regulatory Approval System for Biosimilars, Medicines and Medical Devices (MEX-91) (June 5, 2021)
López-Silva, Christian, Campos-Carmona, David; Baker McKenzie

(Webpage) Adverse Reaction Reporting by Health Registration Holders or Legal Representatives, Contract Research Organizations, Distributors and Marketers (MEX-45 - Spanish) (October 26, 2021)
Federal Commission for the Protection Against Sanitary Risks (COFEPRIS), Ministry of Health

(Webpage) Adverse Reaction Reporting by Patients/Consumers/Healthcare Professionals (MEX-78 - Spanish) (October 21, 2021)
Federal Commission for the Protection Against Sanitary Risks (COFEPRIS), Ministry of Health

(Webpage) Adverse Reaction Reporting by State Centers, Institutional Coordinating Centers, Institutional Centers, and Pharmacovigilance Units of the National Health System (MEX-77 - Spanish) (October 22, 2021)
Federal Commission for the Protection Against Sanitary Risks (COFEPRIS), Ministry of Health

(Webpage) To the Community that Executes Research Projects for Health in Human Beings: Compliance with NOM-012-SSA3-2012 (MEX-28 - Spanish) (July 30, 2020)
Federal Commission for the Protection Against Sanitary Risks (COFEPRIS), Ministry of Health

(Webpage) UANL Enabled Pre-Assessment Support Unit (UHAP) (MEX-90 - Spanish) (Current as of January 28, 2022)
Faculty of Medicine and University Hospital, Autonomous University of Nuevo León (UANL)

Sources Revised During this Update:

(Legislation) General Health Law (GenHlthLaw - Spanish) (Amended through November 22, 2021)
Congress of the United Mexican States

(Document) Applicable Rates for Health Records, Health Licenses, Import Permits, Export Procedures, and Other Permits or Authorizations - January 1 to December 31, 2022 (MEX-11 - Spanish) (December 27, 2021)
Federal Commission for the Protection Against Sanitary Risks (COFEPRIS), Ministry of Health

(Document) Mexico: Data Protection Laws and Regulations 2021 (MEX-4) (June 7, 2021)
Olivares, Abraham Diaz Arceo and Olivares, Giustavo Alcocer; ICLG

(Document) e-Reporting Instructions for Health Professionals and Patients/Consumers – Notification of Adverse Drug Reactions (MEX-12 - Spanish) (October 2021)
Federal Commission for the Protection Against Sanitary Risks (COFEPRIS), Ministry of Health

(Webpage) Amendment or Modification to the Research Protocol or Inclusions to the Protocol (MEX-74 - Spanish) (Current as of February 15, 2022)
Federal Commission for the Protection Against Sanitary Risks (COFEPRIS), Ministry of Health

(Webpage) Health Permit for the Importation of Medicines and Raw Materials for Human Research (MEX-63 - Spanish) (Current as of February 15, 2022)
Federal Commission for the Protection Against Sanitary Risks (COFEPRIS), Ministry of Health

(Webpage) Modification to Import or Export Permit for Cells and Tissues Including Blood, Its Components and Derivatives, and Other Human Products (MEX-60 - Spanish) (Current as of February 15, 2022)
Federal Commission for the Protection Against Sanitary Risks (COFEPRIS), Ministry of Health

(Webpage) Permission to Export Cells and Tissues Including Blood Components and Derivatives and Other Human Products (MEX-62 - Spanish) (Current as of February 15, 2022)
Federal Commission for the Protection Against Sanitary Risks (COFEPRIS), Ministry of Health

(Webpage) Permission to Import Cells and Tissues Including Blood Components and Derivatives and Other Human Products (MEX-61 - Spanish) (Current as of February 15, 2022)
Federal Commission for the Protection Against Sanitary Risks (COFEPRIS), Ministry of Health

(Webpage) Pharmacovigilance Guidelines and Requirements (MEX-54 - Spanish) (May 14, 2021)
Federal Commission for the Protection Against Sanitary Risks (COFEPRIS), Ministry of Health

(Webpage) Research Protocol Authorization Without (Observed) Risk in Humans (MEX-73 - Spanish) (Current as of February 15, 2022)
Federal Commission for the Protection Against Sanitary Risks (COFEPRIS), Ministry of Health