Guidelines for decree 334 of 2022
August 04 2023
INVIMA published last week 3 guidelines regulating Decree 334 of 2022, originally enacted to simplify the procedures for the renewal or modification of marketing authorizations (MAs) for medicinal products:

1. ASS-RSA-GU77-Guideline for the ex officio review of chemical synthesis medicinal products, medicinal gases, biologicals, homeopathic medicinal products, radiopharmaceuticals, antivenoms and phytotherapeutic medicinal products. This guideline explains the procedure the authority will follow to determine whether a product complies with the conditions under which its MA was granted (e.g. safety and efficacy, quality or legal conditions).

2. ASS-RSA-GU75-Guideline for Mandatory Reporting of Temporary Non-Commercialization of Medicinal and Phytotherapeutic Products. This guideline states that any MA Holder (MAH) must notify INVIMA within 30 calendar days from the date on which it becomes aware of a situation or incident that would lead to the non-commercialization of a medicinal product. The MAH is not obligated to make said notification if the first MA is less than 12 months old or if the situation can be resolved within 30 days.

3. ASS-RSA-GU76 Guideline for Depletion Authorisations for Chemically Synthesised Medicinal Products, Medicinal Gases, Biological Products, Homeopathic Medicinal Products, Radiopharmaceuticals, Antivenoms and Phytotherapeutic Products. This guideline defines the conditions where a depletion authorization is not required and where an authorization is required (e.g. those related to changes in safety and efficacy).

The above-mentioned guidelines can be accessed through this link (in the “Autorización de Comercialización” view). Other relevant guidelines are expected to be published before 8 September 2023 (e.g. quality and safety and efficacy guidelines).