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Table 1 A comparison between the registration laws before and after the Free Trade Agreement presenting the main changes related to medicines

From: Trade agreements and drug access: assessment of the impact of the 2009 Peruvian new drug policy on anti-infectives registration and availability

Articles Law 26842 of 1997 and D.S. 010–97-SA [10] Law 29459 of 2009 [14] and D.S. 016–2011-SA [13, 14]
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
  1. aThe Free Sale Certificate is an official document issued by the authority from the country of origin of the exported product that certified that the product is sold in the country of the manufacturer or exporter. The ‘certificate of pharmaceutical product’ from the International Commerce of WHO is a Free Sale Certificate
  2. APIs Active pharmaceutical ingredients, HRS High regulatory surveillance, TU Taxation Unit