On August 11, 2022, Exempt Resolution No. 1.263, of 2022, of the Institute of Public Health, which approves the guide of modifications to the sanitary registration of pharmaceutical products, was published in the Official Gazette.

This guide was issued due to the need to standardize different services associated to the sanitary registration and to present to the user, in a clear and precise manner, the requirements of each one of them, in order to correctly modify their sanitary registrations.

The guide provides a glossary of terms associated with the matters included in the document, a classification of the modifications according to the aspect that needs to be updated, clarifications on the background information that must be submitted to request a modification of legal aspects of the registration, technical aspects of the registration, analytical aspects of the registration and therapeutic aspects of the registration, as the case may be, and explains the procedure for minor changes in notifications.

If you require additional information on this matter, please contact Andrea Abascal (aabascal@jdf.cl), and/or Rocío Vergara (rvergara@jdf.cl).