By Exempt Resolution No. 2747 of December 2, 2022 and published in the Official Gazette on December 23, 2022, the Public Health Institute approved the “Guide to manufacturing regimes for pharmaceutical products and related health establishments” (hereinafter, the “Guide”).
The approved Guide, of a complementary nature to the regulations, informs, clarifies concepts and orients on the functions that authorized health establishments can perform, in order to facilitate the presentations before the Institute of Public Health and thus avoid rejections and delays of the applications that refer to manufacturing regimes of pharmaceutical products and their relationship with the health establishments authorized to do so.
The document establishes definitions that are used depending on the status of the pharmaceutical product in its production, the types of health establishments, the activities that they can perform and, finally, the existing manufacturing regimes.
The validity of this guide began on December 23, 2022.