We share with you a brief of the New Resolution 550 dated May 29, 2019 regulates the Registration of VITAMINIC, DIETETIC AND FOOD SUPPLEMENTS WITH THERAPEUTIC PROPERTIES as follows:
- The issuance and renewal service fee are set at US $ 500.00, and the cost of any type of change or modification will be US $ 200.00.
- One additional requirement is included: Affidavit stating that the product to be registered and marketed is the same in terms of manufacturing and formulation as declared in the CFS or CPP. In addition, it must indicate that both the owner and the manufacturer are jointly and severally liable for compliance with the standards, as well as the conditions of manufacture and quality control, and for the proven adverse effects on the individual or collective health that the probation may experience, user of the products, caused by the transgression of the norms or of the health conditions.
- Only Stability Studies are required if the shelf life is greater than 24 months.
- The deadline to amend any observations is of 2 MONTHS from the communication, and if it is not corrected, the abandonment will be declared.
- It is not necessary to provide samples or perform analysis on the product.
- The validity of the Certificate of Registration will be 5 years.
- Renewals must be submitted at least 3 months before expiration in order to continue importing
The mentioned Resolution 550 entered into effect the day of publication, June 12, 2019.
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Yolianna Arosemena Benedetti
Regional IP Director