The National Health Regulatory Authority of Nicaragua (ANRS) has issued Administrative Resolution No. 0009/2026, establishing the full digitalization of procedures for products intended for human consumption and definitively eliminating the use of paper in the registration and renewal processes for food and beverages.
The Karplus System as the central platform
The new regulation requires that all applications be processed exclusively through the Karplus System. This platform now centralizes all procedures related to new sanitary registrations, renewals (with or without changes), and modifications.
The process begins with technical accreditation. Access to the Karplus System is not freely created; the responsible professional must obtain user credentials from the ANRS by submitting a Power of Attorney Acceptance issued by Legal Counsel. This step legally links the professional to the product holder, granting full responsibility for the accuracy of the information submitted. Once the “Food and Beverages” module is enabled, the system requires personalized credentials to ensure traceability of all actions.
Operational restrictions: daily submission limits
A key aspect of the resolution is the implementation of daily limits for submitting applications. Companies must adjust their regulatory timelines, as the ANRS has established the following caps:
- New registrations and renewals: Maximum of 5 applications per user per day.
- Modifications: Maximum of 8 applications, permitted only on Mondays, Wednesdays, and Fridays.
These limitations mean that companies with large product portfolios will need to plan submissions further in advance to avoid delays in their commercialization processes. Additionally, the system will operate strictly on business days, from 8:00 a.m. to 5:00 p.m.
Strict controls for Type A Foods
The resolution also strengthens food safety requirements by mandating that products classified as Type A Foods must submit their physicochemical and microbiological analyses. This ensures that higher-risk products meet rigorous quality standards prior to distribution in the domestic market.
Pre-evaluation procedure
To improve processing times, the ANRS has introduced a mandatory initial screening. Once documents are uploaded, the system subjects the application to a pre-evaluation stage. During this phase, technical staff verify that the file is consistent with the type of procedure (new registration, renewal, or modification) and that all documents are legible.
If the application passes this stage, the system generates a unique Application Number. Otherwise, the application is immediately rejected, preventing users from advancing with formal deficiencies that could affect the subsequent technical evaluation.
Correction process and risk of automatic cancellation
The correction process is now fully automated. If deficiencies are identified during the technical review, the professional will receive an electronic notification. The user must address the observations directly within the platform, in accordance with the deadlines established by applicable law.
Failure to comply within the specified timeframe will result in automatic cancellation of the application. This entails the loss of the fee paid and the inability to reuse the application number, requiring the process to be restarted from scratch.
Legal safeguards and remedies
The resolution ensures due process through two administrative remedies:
- Motion for reconsideration: The interested party may request the same authority to review the decision if it is believed to lack technical or legal basis.
- Appeal: If the response is unfavorable, the decision may be challenged before a higher authority, in accordance with the General Health Law.
