By: Gabriela Solis
Circular REF ANRS – DLCC FRUG001 2024 in Nicaragua
The national health regulation authority issued a new circular, which came into force as of March 1. Applies to renewals of chemically synthesized pharmaceutical products for human use, nutritional supplements, natural medicinal products, medicinal cosmetics, biological products and vaccines.
Once the request for product renewal analysis has been made in the Karplus system, the person responsible for the procedure must present, within a period of three business days, a true copy of the dossier in the pharmacy division, together with samples of a commercial presentation of the product. finished product for analysis according to the type, and what is established in the quality verification, (see page 9 of the RTCA) before the National Quality Control Laboratory.
Biological, vaccine or biotechnological pharmaceutical products for human use will undergo renewal analysis in accordance with each NTON standard.
The renewal of the registration will be conditional on the release of the analysis
For pharmaceutical products for human use with current health records to be imported, marketed and distributed in Nicaragua, they must have authorization to carry out the analysis of the first marketing batch, based on the following guidelines:
- This analysis is not omitted in the renewals of the first import batch.
- In the process of renewal of products with a sworn declaration of non-marketing (as stipulated in RTCA), it is exempt from the analysis.
- Samples are presented for renewal analysis of a (commercial) presentation.
- For mutual recognition procedures (Central Americans) it is not a requirement to present samples of the finished product, therefore, the circular does not apply.