Costa Rica Drug Product Registration
MoH
Costa Rica, Ministry of Health
MoH Website
https://www.ministeriodesalud.go.cr/
Timeline for Registration
12-15 months.
Local Authorized Representative
Yes. A local authorized representative is required for drug product registration in Costa Rica and must be appointed through a Power of Attorney (PoA).
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:
- COPP
- Generic Letter
- Qualitative-Quantitative Formula
- Method of Analysis (Finished Product)
- Validation of Method of Analysis (Finished Product)
- Specifications of Finished Product
- Stability Studies
- Monograph/ Leaflet
- Samples
- Working Standard
- CoA of Finished Product
- CoA of Working Standard/Raw Material 13 Safety Data 14 Artworks 15 Power of Attorney
Preparing a complete regulatory dossier is an important step in obtaining marketing authorization. Learn more about pharmaceutical dossier preparation
Frequently Asked Questions
Drug product registration in Costa Rica typically takes around 12–15 months, depending on the completeness of the submitted dossier and the review process of the Ministry of Health (MoH).
Yes. Foreign manufacturers must appoint a local authorized representative through a Power of Attorney (PoA) to support regulatory communication and registration procedures.
The required documents include a Certificate of Pharmaceutical Product (COPP), Generic Letter, qualitative and quantitative formula, analytical methods, stability studies, product specifications, Certificate of Analysis (CoA), product samples, safety data, artwork, and Power of Attorney.
A drug product registration license in Costa Rica is generally valid for five years. Renewal must be completed according to the applicable Ministry of Health requirements.
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