Articles | Law 26842 of 1997 and D.S. 010–97-SA [10] | |
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Type of pharmaceutical product | - Brand medicines - Generic medicines - Diet products and sweeteners - Homeopathic products - Diagnostic agents - Biologic products - Radiopharmaceutical agents | - Medicines * Pharmaceutical specialties * Diagnostic agents * Radiopharmaceutical agents * Medicinal gases - Herbal medicines - Diet products and sweeteners - Biologic products - Compounding preparations |
Requirements for registration and re-registration | - Affidavit assuring the quality, safety and efficacy of the product - Analysis protocol based on an authorized pharmacopeia of finished product - Free sale certificate and certificatea of consumption (if product is imported) | - Application form with character of affidavit - Specifications and analytical techniques of APIs, excipients, final product - Validation of analytical techniques of finished product - Flow chart and validation of process of manufacture - Stability studies - GMP certificate granted by Digemid or from a country with HRS - Free sale certificate or certificate of pharmaceutical producta (for import) |
Timeframe application/evaluation process | Automatic with presentation of requirements, no more than 7 days | Between 45 days to 1 year according to the product’s category |
Amount paid to get the registration license | 10% of TU | 59.74% of TU (category 1) 99.95% of TU (category 2) 99.65% of TU (category 3) |
Term validity | 5 years | 5 years |