MoH

Costa Rica, Ministry of Health

MoH Website

https://www.ministeriodesalud.go.cr/

Timeline for Registration

12-15 months.

Local Authorized Representative

Yes, with power of attorney.

Free Sale Certificate

Yes

License Validity

5 Years

Regulatory Authority

Ministry of Health and WHO oversees all the regulations and market authorizations.

Generic Drug Registration Process

• In Costa Rica, MOH is the regulatory agency.
• Generic medicine registration requires filing a dossier with the MOH, and marketing of the medication requires Caja Costarricense De Seguro Social (CCSS) approval.
• The following requirements should be submitted to the MOH for receiving the marketing of the generic drug:

1. COPP
2. Generic Letter
3. Qualitative-Quantitative Formula
4. Method of Analysis (Finished Product)
5. Validation of Method of Analysis (Finished Product)
6. Specifications of Finished Product
7. Stability Studies
8. Monograph/ Leaflet
9. Samples
10. Working Standard
11. CoA of Finished Product
12. CoA of Working Standard/Raw Material 13 Safety Data 14 Artworks 15 Power of Attorney