By: Olga Torres
This day it has been announced that on 18/09/2023 Deputies of the Finance Commission of the Legislative Assembly approve a favorable opinion of the new law on rates for services of the National Directorate of Medicines, where the following changes can be identified starting January 2024:
Table 1: Pharmaceutical Products
| PHARMACEUTICALS | ||
| Service | Current rate | Approved rate |
| Biological, biotechnological, vaccines, innovative health registry | $ 352- $ 536 | $1,500 |
| Generic bioequivalence health registry | $ 352- $ 536 | $1,000 |
| Other pharmaceutical products | $400 | $600 |
| Complex modifications: in vivo or in vitro bioavailability and bioequivalence study evaluation | $ 25- $ 250 | $420 |
| Change in therapeutic indication or joint marketing authorization | $ 25- $ 250 | $120 |
| Modifications of medium complexity | $ 25- $ 250 | $120 |
| Modifications to the professional or additional representative due to the record affected by the modification | $ 25- $ 250 | $0.60 |
| Other modifications to the registry | $ 25- $ 250 | $48 |
| Annual renewal of marketing authorization | $ 50- $ 75 | $45 |
| Annual maintenance fee for market surveillance | Does not exist | $100 |
| Release or exemption of batches of biological products | Does not exist | $100 |
Table 2: Cosmetic and Hygienic Products
| COSMETIC AND HYGIENIC PRODUCTS | ||
| Service | Current rate | Approved rate |
| Obtaining health registration, marketing authorization, renewal | $75 and $25 renewal | $240 |
| Modifications to the professional or representative 1 record | $25 | $48 |
| Additional fee for registration affected by modification | $25 | $0.60 |
| Other later modifications | $25 | $48 |
| Annual renewal of authorization or marketing | $25 | $25 |
| Annual Maintenance Fee for Market Surveillance (registered products sold within the country) | Does not exist | $35 |
In addition, the new regulations establish new rates for services related to medicines, cosmetics, chemicals and medical materials:
| OTHER SERVICES | |
| Service | Approved rate |
| Annual maintenance fee for market surveillance for pharmaceutical products. | $100 |
| Annual maintenance fee for market surveillance for cosmetic and hygiene products. | $35 |
| Annual maintenance fee for market surveillance for medical devices and other health technologies. | $85 |
| Laboratory analysis for quality control of medical devices and other health technologies for antiseptic and disinfectant products for hospital medical use, surgical sutures, endotracheal tubes or tracheostomy tubes | $750 |
| Laboratory analysis for quality control of medical devices and other health technologies for surgical masks, particulate respirators, scalpel blades, medical adhesive tapes, urine collection bags, condoms or condoms | $1,000 |
| Laboratory analysis for quality control of medical devices and other health technologies for analysis of biosafety suits for medical use, needles, catheters, gloves, clothing and surgical fields of material or fabric | $1,500 |
| Laboratory analysis for quality control of “other” medical devices and other health technologies | $1,200 |
| Laboratory analysis for cosmetic and hygiene products, and raw materials for pharmaceutical use | $750 |
| Exemption of batches of biological products | $100 |
To know the total changes per procedure, consult the National Directorate of Medicines.