Mexico · Federal Commission for the Protection against Sanitary Risks · Over-the-counter
Review target
-
Not published
Legal time limit
-
Not published
Steps
3
3 requirements
Application fee
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There is no separate registration route for nonprescription medicines. They get a sanitary registration as allopathic medicines. The law sorts medicines into sale groups, including medicines sold without a prescription only in pharmacies and medicines that can be sold in other stores. Medicines intended for sale without a prescription.
1. File a medicine registration; 2. Review; 3. Decision and sale group.
Outcome: A sanitary registration for an allopathic medicine, placed in a sale group. Valid for 5 years.
Legal basis: Ley General de Salud, articles 226 and 227; Reglamento de Insumos para la Salud, article 167
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).
Official step durations
In order, with the official target for each step
What the applicant must provide or meet
Targets, not actual review times
| No time targets published. |
Official amounts in the local currency
| Fee | Amount |
|---|---|
| No fees published. |
Other routes in Mexico: Registration of herbal, homeopathic and vitamin 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 (9 facts checked). Parts of the approvals data are official open data reused under open licences. Data sources.