Dear all,
In accordance with the User Guide for the submission of Risk Management Plans for Human Use Medicines, issued by the National Health Regulatory Authority (ANRS) of the Ministry of Health of Nicaragua and published on March 13, 2026, we hereby inform you:
The objective of the guide is to indicate the requirements and steps to follow for the submission of a Risk Management Plan for Human Use Medicines.
The scope of the guide covers the process from submission, evaluation, and issuance of the acceptance certificate for the Risk Management Plan.
Prerequisites:
3.1 Assignment of a responsible professional by the Marketing Authorization Holder before the Directorate of Pharmacy.
3.2 Payment of the corresponding fee for the procedure: Issuance of Certificates for the Risk Management Plan for Human Use Medicines, code DF-047.
General considerations:
4.1 The responsible professional is in charge of submitting the Risk Management Plans to the Directorate of Pharmacy.
4.2 The Risk Management Plan must be submitted mandatorily in the following cases:
a. Application for sanitary registration of a new active ingredient.
b. Application for sanitary registration of a biotechnological, biological, or orphan drug.
c. In cases where ANRS identifies health risks that require its submission.
d. In cases where significant changes occur in the initial authorization conditions of the medicine.
Steps to follow:
5.1 Payment for the issuance of the Risk Management Plan certificate for Human Use Medicines.
5.2 Request for evaluation of the Risk Management Plan.
5.3 Evaluation of the Risk Management Plan.
Contact: All information related to this guide can be consulted through the email addresses farmaciadir@minsa.gob.ni and infmedica@minsa.gob.ni.
For any additional questions, please feel free to contact us.
Sincerely,
Claudia Vanessa Perén
AARSA