By: Gabriela Solis
- What is the technical documentation's importance in the sanitary registration process of pharmaceutical products for human use in Nicaragua?
The sanitary registration for medicines process constitutes the main approval procedure by the Nicaraguan sanitary regulation authority, for pharmaceutical product marketing for human use, which must be submitted through a technical, pharmacological, and legal evaluation process to verify prior compliance. Therefore, everything related to the requirements for Pharmaceutical Products for human use Health Registry in Nicaragua is 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.
- What elements are essential for your presentation?
- Current legal documents in original or notarized copy.
- Pharmacological information, reference regulatory 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.
- How to manage changes and updates to documentation?
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.