What health registration is
It is the procedure by which a pharmaceutical product undergoes a prior assessment before being marketed (Law 1737, article 6).
Who files it
Industrial pharmaceutical laboratories and importers with a valid operating authorization. That is why opening the company comes before registering its products.
The manual and its amendments
The base framework is the Manual for Health Registration (RM 0909/2005), organized into general provisions, requirements, procedures, flowcharts, instructions, batch registration and related services. The file gathers legal, administrative, technical and informational content.
AGEMED circulars and resolutions amend the manual item by item, without republishing it. That is why each item must be read together with its amendments. For example, Form 005 is filled in on the MISA platform since October 17, 2022 (CR-70-2022), and the dossier for the second part of the evaluation is handled digitally (CR-2-2025).
Renewal
AGEMED also regulates the renewal of medicines on the MISA platform (CR-60-2022). The applicable date depends on each registration.
Sources
- RM-0909-2005: Manual for Health Registration (chapters I to VII)
- Medicines Law No. 1737, art. 6 (cited in the CADA Directive, RA-24-2024)
- CR-70-2022: Form 005 on the MISA platform
- CR-2-2025: digital dossier for the second part of the evaluation
- CR-60-2022: renewal of medicines on MISA
General information. Requirements are subject to the current AGEMED regulations.