UPDATE OF REGULATION No. 063 ‘PHARMACOVIGILANCE STANDARD AND MANUAL FOR REPORTING SUSPECTED ADVERSE REACTIONS ASSOCIATED WITH MEDICATIONS’ – NICARAGUA

“We hereby share the updated REGULATION No. 063 ‘PHARMACOVIGILANCE STANDARD AND MANUAL FOR REPORTING SUSPECTED ADVERSE REACTIONS ASSOCIATED WITH MEDICINAL PRODUCTS,’ issued by the National Health Regulation Authority (ANRS) of Nicaragua. Attached you will find the full resolution, along with a summary of the key points, as follows:

NAME:
REGULATION No. 063 “PHARMACOVIGILANCE STANDARD AND MANUAL FOR REPORTING SUSPECTED ADVERSE REACTIONS ASSOCIATED WITH MEDICINAL PRODUCTS”

COUNTRY OF APPLICATION:
NICARAGUA

Background

In 2011, pharmacovigilance regulations were implemented as part of the National Health Policy, with the purpose of regulating activities related to the safety, efficacy, and quality of medicines and vaccines. This regulation ensures the safe use of medicines and vaccines through a risk/benefit assessment and establishes an active monitoring structure for therapeutic use.

Since the approval of Regulation 063 in 2011, a sensitization and training plan was implemented for those responsible for medical supplies in the Local Comprehensive Health Care Systems (SILAIS), which significantly increased the number of adverse reaction reports, especially from 2012 onward.

In 2019, Nicaragua adopted the Noti-FACEDRA system, a regional platform for monitoring adverse reactions, improving accessibility and reporting quality. Additionally, in 2020, Nicaragua became a full member of the WHO Programme for International Drug Monitoring, strengthening its pharmacovigilance system under international standards.

Through Administrative Resolution 0009/2025, an update to Regulation No. 063 “Pharmacovigilance Standard and Manual for Reporting Suspected Adverse Reactions Associated with Medicinal Products for Human Use” is presented.

Definition of the Regulation

The regulation establishes a set of guidelines to ensure the timely reporting of suspected adverse reactions to medicines and vaccines used for diagnostic, preventive, or therapeutic purposes in humans. Its purpose is to guarantee the safe use of these products by identifying and assessing any potential risks.

Objective of the Regulation

The objective is to regulate the organization and operation of the technical and administrative processes related to pharmacovigilance of pharmaceutical products. This includes practices for monitoring, reporting, and evaluating adverse effects to ensure the system operates efficiently and in compliance with established standards.

Scope of Application

The regulation applies to all healthcare providers, health professionals, health research institutions, marketing authorization holders, legal representatives, distributors, and marketers of pharmaceutical products. It covers public and private sectors involved in research, distribution, and use of medicines and vaccines.

General Provisions

National Pharmacovigilance System (SNFV):

The SNFV is coordinated by the Pharmacovigilance Department of MINSA, which continuously integrates and evaluates activities related to medication safety, including those within public health programs such as immunization, HIV, malaria, and tuberculosis.

Responsibilities of the Pharmacovigilance Department:

  • Identify, assess, and manage medication-related risks, supported by the National Pharmacovigilance Commission (CNFV).

  • Does not replace the responsibilities of the pharmaceutical industry.

Education and Training:

  • Higher education institutions must include pharmacovigilance in academic programs to promote a culture of systematic adverse reaction reporting.

  • Continuous training in medication safety and pharmacovigilance is encouraged.

Inspection and Good Pharmacovigilance Practices (GPP):

  • Inspections will be conducted to ensure compliance with GPP in both public and private health establishments and within the pharmaceutical industry.

Specific Provisions

The Pharmacovigilance Department must:

  • Manage, safeguard, and ensure confidentiality of information in SNFV databases.

  • Promote the use of the regional online reporting platform Noti-FACEDRA.

  • Provide ongoing training in medication safety to health facilities.

  • Ensure health personnel are trained in the Noti-FACEDRA platform.

  • Register suspected adverse reactions truthfully.

  • Thoroughly document serious or unknown suspected adverse reactions, including:

    • Reactions to new medicines (less than 5 years on the market).

    • Severe or unexpected reactions to older medicines (over 5 years).

    • Increased frequency of known adverse reactions.

    • Reactions caused by interactions between medicines, foods, supplements, or lab tests.

    • Reactions in vulnerable groups (children, elderly, pregnant/lactating women, substance abuse).

    • Withdrawal reactions.

    • Overdose or medication errors.

    • Pharmaceutical defects or lack of efficacy.

    • Adverse reactions to medicines used in public health programs (antibiotics, ARVs, vaccines, etc.).

  • All suspected adverse reactions must be verified against original documents.

  • Patient and reporter confidentiality must be protected.

  • Deadlines for reporting serious reactions must be strictly followed.

  • Suspected adverse reactions must be recorded and stored in MINSA systems for verification and communication.

  • Standard Operating Procedures (SOPs) must be established.

  • Adverse reaction information must not be used for punitive action against medical practice.

  • The total number of adverse reaction notifications must be recorded, including product categories and form completion accuracy.

Reporting System:

  • Reports must be submitted through Noti-FACEDRA via MINSA’s web portal: www.notificacentroamerica.net.

  • If technical issues prevent access, the Pharmacovigilance Department must be contacted at infmedica@minsa.gob.ni.

  • SILAIS must record adverse reaction notifications within their jurisdiction, categorized by product type (medicines, vaccines, herbal products, supplements, etc.).

  • Hospital pharmacovigilance committees or the medical director must verify report accuracy before submission.

Additional Obligations:

  • Pharmacovigilance Department must promote adverse reaction reporting and provide feedback via various means, including semi-annual bulletins.

  • Establishment epidemiologists must receive and report adverse reaction notifications (antituberculosis drugs, ARVs, vaccines, antimalarials, blood products, oncology drugs).

  • Health professionals must:

    • Verify complete reports with updated contact information.

    • Maintain clinical documentation of the event in patient records.

    • Provide additional information when requested.

  • Anyone may report suspected adverse reactions through Noti-FACEDRA or at health establishments.

  • Laboratories and marketing authorization holders must:

    • Report received adverse reactions (mild, moderate, severe) within established timelines.

    • Severe reactions: within 24 hours, with complete data within 7 days.

    • Non-severe reactions: within 15 days.

    • If Noti-FACEDRA is unavailable, the CIOMS form may be emailed.

    • If a case is identified on Friday, submission the next business day is accepted.

Requirements for Marketing Authorization Holders (MAHs):

  • Must have approved SOPs for pharmacovigilance activities.

  • The pharmaceutical manager cannot serve as the pharmacovigilance officer.

  • Must use MedDRA (medical terminology) and WHODrug (medication/vaccine terminology) for coding within 180 days of implementation.

Licensing:

SOPs must cover:

  • Data collection, coding, registration, assessment, follow-up, duplicate detection, and reporting.

  • Implementation of regulatory safety measures.

  • Preparation and submission of Periodic Safety Update Reports (PSURs).

MAHs must:

  • Continuously evaluate safety profiles.

  • Identify signals and assess benefit-risk relations.

  • Apply risk management plans.

  • Implement urgent safety measures when necessary.

  • Maintain secure and validated databases.

  • Keep organized pharmacovigilance documentation.

  • Ensure trained and qualified personnel.

MAHs must submit updated PSURs with corresponding fees for:

  • Innovative, biotechnological, biological, chemical synthesis, and interchangeable medicines.

PSUR Submission Frequency:

  • Every 6 months for the first 2 years.

  • Annually for the next 3 years.

  • Every 5 years thereafter.

Submission Deadline:
90 days after data lock point, via the Karplus system.

If alternative timelines are requested, detailed justification must be provided.

PSUR Format Must Include:

(Full list preserved exactly as in the original text)

[The entire detailed list is included unchanged in English, as above.]

Additional Requirements

  • Reports not meeting regulatory standards must be corrected.

  • Laboratories must immediately notify authorities of any restrictions, bans, or new safety information. Failure to report is considered a serious offense.

  • The pharmacovigilance department may request post-marketing safety/efficacy studies.

  • MAHs must submit a Risk Management Plan (RMP) when:

    • Registering a new active ingredient.

    • Registering biotechnological, biological, or orphan medicines.

    • Risks are identified by the department.

    • Authorization changes are significant.

RMP structure includes:

  • Part I: Product summary

  • Part II: Safety profile

  • Part III: Pharmacovigilance plan

  • Part IV: Post-authorization efficacy studies

  • Part V: Risk minimization measures

  • Part VI: Summary

We encourage you to consult the attached resolution for more detailed information on the applicable provisions in Nicaragua.


📄Download Official Statement