By: Gabriela Solis
1. What is the importance of technical documentation in the sanitary registration process of pharmaceutical products for human use in Nicaragua?
The sanitary registration process for medicines constitutes the main approval procedure by the Nicaraguan sanitary regulation authority, for the marketing of a pharmaceutical product for human use, which must undergo a technical, pharmacological and legal evaluation, in order to verify prior compliance. Therefore, everything related to the requirements for the Health Registry of pharmaceutical products for human use in Nicaragua are established in the Central American technical regulation RTCA 11.03.59:18 and Law No. 292 “Medicines and Pharmacy Law and its Regulations” .
It is a key aspect that guarantees the safety and quality of medicines for human use.
2. What elements are essential elements for your presentation?
- Current legal documents in original or notarized copy.
- Pharmacological information regulatory reference authority level IV of the pharmaceutical product.
- Technical information (signed and sealed original formula, quality specifications, validated analytical methodology, finished product certificate, stability study, packaging projects, sample of the current finished product.
- All documentation must be presented in Spanish and in its original language.
3. How to manage documentation changes and updates?
Likewise, during the Pharmaceutical Product Health Registry validity period, it may undergo modifications either in the technical, pharmacological, or legal part, which must be reported to the health regulation authority, scientifically supporting the reasons for the change, to that they are authorized.
Any modification to the registry must comply with the Central American technical regulation RTCA 11.03.59:18. (see annex 1 classification and requirements for modifications to the health registry).
The responsible professional may request any post-registration changes if the power granted by the owner of the product grants him that power.