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Changing or Transferring Your MRH

Transferring a COFEPRIS sanitary registration from one Mexico Registration Holder (MRH) to another is a formal regulatory process. It is not instantaneous — the transfer process can take several months, during which market access may be affected.

Why you might need to change MRH​

  • Commercial dispute with current MRH or distributor (if they are the same entity).
  • MRH ceasing to operate or losing its regulatory standing.
  • Strategic decision to separate your regulatory and commercial relationships.
  • Merger or acquisition of the MRH entity.

The transfer process​

  1. Notify the current MRH of your intent to transfer.
  2. Identify and appoint a new MRH that meets all legal requirements.
  3. Prepare transfer documentation — new power of attorney, new MRH credentials, application for modification via DIGIPRiS.
  4. Submit a modification application to COFEPRIS requesting the change of registration holder.
  5. COFEPRIS review and approval — the registrations remain under the current MRH until COFEPRIS formally approves the transfer.
  6. Registration updated — COFEPRIS updates the register to reflect the new MRH.

Risks during transfer​

  • The current MRH legally holds your registrations until transfer is complete. If the relationship breaks down, you may lose access to your registration details.
  • COFEPRIS will continue to direct regulatory correspondence to the old MRH until the transfer is approved.
  • If the old MRH fails to cooperate, the process becomes more complex.
Protect yourself contractually

Ensure your MRH agreement includes clear cooperation obligations in the event of exit or transfer, and specify ownership of the technical dossier documentation.

Timeline​

Transfer timelines are not officially stipulated by COFEPRIS but typically range from 2 to 6 months in practice. Complex situations or uncooperative outgoing MRHs can extend this significantly.

Protecting continuity​

  • Begin the transfer process well before any relationship breakdown escalates.
  • Maintain copies of all dossier documentation independently — do not rely solely on the MRH's copies.
  • Consider naming rights to the technical dossier explicitly in your MRH contract.