Alternative medicine · Category 3

Sanitary Registration of Homeopathic Products in Costa Rica

Comprehensive management of sanitary registration for homeopathic medicines for human use before the Ministry of Health under Decree N° 39294-S (RTCA 470:2014 Regulation). New registrations, renewals, and post-registration changes.

Homeopathic products registration Costa Rica
Registration characteristics

Distinct regulatory framework for alternative medicine

Homeopathic products have a regulatory framework distinct from conventional medicines. The registration includes specific provisions on formulation, analytical methods, and labeling adapted to their nature.

5
Years of registration validity
100%
RTCA 470:2014 compliance
3
Modalities: Registration, Renewal, Post-registration
2
Submission methods: digital and physical
Service scope

Complete procedures

Types of procedures

  • Registration of new homeopathic products under the current regulatory framework
  • Renewal of sanitary registration upon expiration of the 5-year validity
  • Post-registration changes in accordance with Annex 1 of RTCA 11.03.59:18 Regulation

Documentation managed

  • WHO-type Pharmaceutical Product Certificate
  • Free Sale Certificate
  • Good Manufacturing Practices Certificate
  • Qualitative-quantitative formula per dosage unit
  • Validated analytical methods
  • Finished product specifications
  • Primary packaging, secondary packaging, and insert labels
Homeopathic documentation
Saluvexis service

What does the service include?

1

Assessment

Product feasibility analysis and classification

2

Documentation

Dossier compilation with all certificates

3

Submission

Physical or digital path before the Ministry of Health

4

Follow-up

Response to inquiries and post-registration maintenance

Have homeopathic products for Costa Rica?

Let's discuss your entry to the Costa Rican market.

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Health brings us together

Your homeopathic product in compliance in Costa Rica

Complete management of registration, renewal, and post-registration changes.