On November 8th, INVIMA finally published the guidelines for modifications to health registrations for medicinal products pending since the issuance of Decree 334 in March 2022 and Decree 1474 in September 2023.
The above-mentioned Directives correspond to:
- 9ASS-RSA-GU044-Guideline for the submission of safety and efficacy variations to marketing authorizations for biological medicinal products.
- 9ASS-RSA-GU049-Guidelines for the submission of variations to marketing authorisations with an impact on the quality of biological medicinal products.
- 9ASS-RSA-GU73 -Guideline for administrative-legal changes to health registrations for chemically synthesized medicinal products.
- 9ASS-RSA-GU079 -Guidelines for the submission of safety and efficacy variations to Marketing Authorizations for chemically synthesized medicinal products and medicinal gases.
- 9ASS-RSA-GU82- Guideline for the submission of variations to marketing authorizations affecting the quality of medicinal products of chemical synthesis, medicinal gases and radiopharmaceuticals.
Additionally, resolution 2023052539 updating official fees for some of the above-mentioned changes was issued.
