Mexico · Federal Commission for the Protection against Sanitary Risks · New drugs
Review target
-
Not published
Legal time limit
45 working days
regulation
Steps
3
4 requirements
Application fee
MX$26,398
2026
Herbal, homeopathic and vitamin medicines have a shorter registration procedure. The regulation gives the agency 45 days to decide. For homeopathic medicines, no answer in time means the application is approved. Medicines made from plant material, homeopathic medicines, and vitamin medicines.
The application and registration of a homeopathic, herbal or vitamin medicine is MX$26,398 for 2026.
1. File the application; 2. Review and decision period (45 days); 3. Decision.
Outcome: A sanitary registration valid for 5 years, renewable for 10-year periods. Valid for 5 years.
Legal basis: Reglamento de Insumos para la Salud, articles 172 to 175
Each box is one step; arrows show the order. Dashed boxes happen only in some cases; the orange arrows go back (for example after questions).
About 45 days end to end with the official step targets. Targets, not actual times.
In order, with the official target for each step
What the applicant must provide or meet
Targets, not actual review times
| Legal time limitregulation. Legal limit, not an actual review time. Shorter times have been announced; see the list of rule changes. | 45 working days |
Official amounts in the local currency
| Fee | Amount |
|---|---|
| Application and registration of a homeopathic, herbal or vitamin medicineApplication · 2026 | MX$26,398 |
Other routes in Mexico: Registration of a medicine with a new molecule, Registration of a medicine with active substances and indications already registered, Registration of a generic medicine, Registration of a nonprescription medicine, Abbreviated reliance route for medicines. See all routes on the Mexico page or explore them in the Regulatory section.
Not legal or regulatory advice. Check the current official rules before you act. This summary was checked against the official laws, regulations and regulator guidance on October 3, 2026 (13 facts checked). Parts of the approvals data are official open data reused under open licences. Data sources.