Dear all,
In accordance with Ministerial Resolution No. 29-2026, which establishes the inclusion of the substances HEXAHYDROCANNABINOL (HHC) and CARISOPRODOL (as a single-ingredient or in combination), issued by the National Health Regulatory Authority (ANRS) of the Ministry of Health of Nicaragua and published on March 10, 2026, we hereby inform you:
- This Resolution shall be mandatory for national and foreign laboratories, as well as for duly authorized importers, distributors, and marketers.
- From the entry into force of the resolution, establishments must submit, within a maximum period of ten (10) calendar days, to the Directorate of Pharmacy of ANRS, an inventory report of available products containing the aforementioned substances, duly signed by the Responsible Pharmacist and the authorized Legal Representative. Note: The format to be submitted shall follow Annex I.
- The Supervision and Inspection Department of the Directorate of Pharmacy of ANRS will carry out verification processes through sanitary surveillance in establishments that have products containing these substances.
- Establishments must withdraw medical samples of products containing the aforementioned substances within a maximum period of thirty (30) working days from the entry into force of the circular.
- Once the withdrawal has been completed, a detailed report must be submitted to the Directorate of Pharmacy within a maximum period of five (5) calendar days, including quantities imported, distributed, and withdrawn. The Directorate of Pharmacy may carry out sanitary surveillance inspections to verify the submitted information.
Note: The format to be submitted shall follow Annex II.
- The holder of the Sanitary Registration for products containing these substances must submit, within a maximum period of sixty (60) calendar days, the modifications to the Sanitary Registration (in accordance with RTCA and other applicable provisions), including:
6.1 Update of sales modality
6.2 Update of monograph and package insert (if applicable)
6.3 Update of secondary packaging project information, including special labeling and sales modality
6.4 Discontinuation of presentations (medical samples, if applicable)
- All advertising materials, whether authorized or not by the Directorate of Pharmacy, related to products containing these substances, are automatically canceled; therefore, their distribution must be suspended and all previously distributed materials must be immediately withdrawn.
- The establishment’s Responsible Pharmacist must request quota authorization for the substances, complying with the established requirements.
- An Import Permit must be obtained for the importation, distribution, and commercialization of the aforementioned substances (as a single-ingredient or in combination), whether as raw material, finished product, samples for Sanitary Registration, and/or reference standard.
Note: The import permit shall have a validity of one (1) calendar year from the date of authorization and shall be non-transferable.
- For invoice endorsement of the aforementioned substances, whether as raw material, finished product, samples for Sanitary Registration, and/or reference standard, current requirements must be complied with.
- Establishments must submit, within the first ten (10) days of each month, to the Directorate of Pharmacy, the monthly inventory report of products containing the aforementioned substances (as a single-ingredient or in combination).
- The circular includes a QR code with the list of products containing the aforementioned substances (attached for reference).
For any additional questions, please feel free to contact us.
Sincerely,
Claudia Vanessa Perén
AARSA