Mexico · Federal Commission for the Protection against Sanitary Risks · Vaccines
Review target
-
Not published
Legal time limit
-
Not published
Steps
4
5 requirements
Application fee
-
Vaccines use the same medicine registration procedure as other allopathic medicines, plus the standards for biological products. Before sale or distribution, each lot needs prior authorization based on laboratory results. Toxoids, bacterial vaccines and viral vaccines, and other biological products such as blood products.
1. File the registration application; 2. Review; 3. Registration decision; 4. Lot release for sale or distribution.
Outcome: A sanitary registration, then a sale or distribution permit for each lot. Valid for 5 years.
Legal basis: Ley General de Salud, articles 229 and 230; Reglamento de Insumos para la Salud, articles 43 and 169
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 an innovative biotechnology 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 (11 facts checked). Parts of the approvals data are official open data reused under open licences. Data sources.