Ministerio de Salud de Costa Rica
https://www.ministeriodesalud.go.cr/
Costa Rica’s Registered Drug database is very well managed by the Costa Rica’s Drug Regulatory Authority (Ministerio de Salud de Costa Rica).
Registered database is updated on monthly basis within a year and provides downloadable xls sheet for the following categories.
Registered product search is also available in the website year vise in the database.
· Foods
· Cosmetics
· Biomedical equipment and material
· Medicines
· Pesticides
· Natural products
· Hygiene products
· Hazardous chemicals
· Tattoo Inks
Pricing: is not available in the online database.
Languages: Spanish
Database xls sheet provide the detailed information of the registered product e.g.
- COUNTRY
- CONSECUTIVE
- EXPIRATION
- NAME REMARKS
- MANUFACTURER SESSION
- ARTICLE
- PRODUCT TYPE
- LABORATORIO HOLDER
Medicines
Legislation
· Law No. 5395. General Health Law
· Decree 28466-S. Regulation of registration, control, importation and advertising of medicines
· See more regulation for medicines >>
Products registered
· List of registered drugs
Applications
· Request for the return of money (Not applicable for registrations in the System Register it).
· Instructions for completing the application form for the return of money
Medication registration
· Applications
o Application for registration of medicines
o Application for registration of biological medicines
o Radiopharmaceutical registration application form
o Application form for prior review of advertising of products of health interest
· Documents
o Receipt by deposit for paperwork
o Requirements for registration of medicines
o Press release DRPIS-UR-484-2015. Register of Medicinal Gases
o Press release DRPIS-UR-097-2015. Clarification on radiopharmaceutical registration
o Proof of submission of medication dossiers
o Interpretation of the power of legal representative and certification of the contract of manufacture of third parties for the sanitary registration of medicines
o Communiqué on "Procedure for the application of the single prevention"
o Circular DRPIS-1554-12-2013. Interested in advertising Products of Health Interest
o Press Release DAC-400-2012. Bioequivalence Study Requirements and Comparative Dissolution Profile Studies
o Communiqué DAC-UPS-004-C-2012. Re-establishment of the requirement of bioequivalence studies (207.5 kB)
o Circular DRC-913-09-08. Stability Study
o Circular DRC-911-09-08. Change in state control procedure
o Circular DRC-785-07-08. Certification of bioequivalence
o Circular DRC-106-01-07. Omission of photocopies of bibliographical citations that support the monograph
o Circular DRC-067-01-07. Users of the System of Registration of Medicines, Cosmetics, Natural Products, Food and Biomedical Equipment and Material
· Guides
o Validation guide for analytical methods
o Medication registration application compliance guide
o Medication Registration Request Filing Guide
o Guide for the technical evaluation of drug labeling
o Technical assessment guide for stability studies
o Guide for the technical evaluation of monographs
o Technical evaluation guide of clinical studies for the sanitary registration of medicines
o Guide to the technical evaluation of the qualitative quantitative formula for the sanitary registration of medicines
Post-medication changes
· Applications
o Request for post-registration changes to medicines
· Guides
o Guide to filling out the request for post-registration drug changes
o Guide to compliance with the request for post-registration changes to medicines
Renewal of medicines
· Applications
o Request for drug renewal
· Documents
o Affidavit on the stability study for the renewal of the registration of medicines
o Affidavit on the Quali-Quantitative Form for Renewing the Registration of Medicines
o Press Release DAC-UPS-12-09 - Renewal of Drug Registration (Nov 16, 2006)
· Guides
o Medication Replacement Request Filing Guide
o Guide to compliance with the application for renewal of registration of medicines
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