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Costa Rica Drug Product Registration

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Costa Rica Drug Product Registration

Safeguarding Public Health Through Comprehensive Regulation

MoH

Costa Rica, Ministry of Health

MoH Website

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

Sanatory Registration Fees

US$ 520.00

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

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