Colombia’s New Pharmacovigilance Regulations: What MAHs Need to Know Are you up to date with Colombia’s latest pharmacovigilance regulations?

 INVIMA (Instituto Nacional de Vigilancia de Medicamentos y Alimentos) is the entity responsible for the surveillance activities of medicines in Colombia, and new regulation has recently come into effect, impacting all Marketing Authorization Holders (MAHs) .

Here’s what every MAH should know

Pharmacovigilance System Master File (PSMF):

MAH must establish a PSMF describing the pharmacovigilance activities, responsibilities, and verification activities performed for the marketed products; this file must be available in Spanish.

In addition to the documentation framework, INVIMA has emphasized the importance of having a qualified local representative, as follows.

Appointing a Local Person Responsible for Pharmacovigilance (LPPV):

MAH must nominate a LPPV before INVIMA; this person must be a physician or pharmacist, reside in the country, and be available permanently and continuously. This person will be the point of contact for safety matters related to the marketed products.  

Once the local role is established, companies must also ensure accurate and timely reporting of adverse events.

ICSR (Individual Case Safety Report) Submission: Timelines and Platform Requirements

MAH must submit ICSR to INVIMA through “e-Reporting.” This web-based application is compliant with ICH E2B-R3 requirements, and the use of MedDRA terminology and WHODrug Dictionary is mandatory. INVIMA has established different timelines for ICSR submission according to its seriousness:

  • Serious ICSR: Must be notified within 15 calendar days after the awareness date.
  • Non-serious ICSR: Must be notified within 90 calendar days after the awareness date. 

Additionally, if no adverse events are received for the marketed products during a quarter, a report indicating this must be submitted to INVIMA.

PSUR/PBRER Preparation and Submission Rules:

Periodicity and data lock point (DLP) for preparation will be determined as per EURD list2. Submission is mandatory only upon request from INVIMA, but it must always be available. These reports can be prepared in English or Spanish. In the case of preparing them in English, a translation of the executive summary is required. 

In addition to periodic reporting, companies are also expected to maintain proactive risk planning through RMPs.

When to Submit a Risk Management Plan (RMP)

RMP submission is required under the following circumstances3:

  • For innovative medicines, it must be submitted along with the market authorization application (MAA).
  • For biological products, it must be submitted along with the MAA or renewal application.
  • If there is new evidence affecting the risk balance profile or relevant modifications an update of RMP must be submitted.

Partnering with an expert pharmacovigilance provider can make all the difference to comply with these evolving requirements. Let us be your partner for pharmacovigilance in Colombia.

Key Takeaways

  • A new INVIMA regulation is now in force, introducing clear responsibilities for MAHs in Colombia, including documentation, safety reporting, and risk planning.
  • MAHs must appoint a qualified LPPV based in Colombia and ensure the timely submission of ICSRs via the e-Reporting system in compliance with ICH E2B-R3.
  • PSURs, PBRERs, and RMPs must be prepared proactively and made available upon INVIMA request, even if the submission is not always mandatory.
  • Partnering with an expert pharmacovigilance provider like Freyr can ensure full compliance and help you confidently navigate Colombia’s regulatory environment.

How Freyr Supports Your Pharmacovigilance Strategy in Colombia

Freyr Solutions offers specialized support to navigate INVIMA regulations and streamline your post-marketing surveillance processes, including LPPV, ICSR processing and submission, PSUR and RMP preparation and submission, global and local literature monitoring, and safety regulatory intelligence.

Connect today with our pharmacovigilance experts to ensure compliance and optimize your strategies for success in Colombia's healthcare ecosystem.

Comments

Post a Comment

Popular posts from this blog

Medical Device Regulation Report, Morocco, Registration

This report provides information on regulations imposed on medical device in Morocco for product registration, import permit, validity & renewal process, variations filing, legal representative and labeling. Summary Product definition and governing regulations; Information on medical device registration; Explains the process of registration through flowcharts; Precise information on health authority fees & timelines for registration; Additional information on the validity of registration, renewal process and variation filing Presents the regulations applicable on labeling; and Describes the information on import regulations, and the requirement of a legal representative. Check out more details at  Medical Device Regulation Report, Morocco, Registration
Read more

Medical Device Registration in Germany, IVDs, CE marking, EU MDR

Freyr offer Regulatory services for Medical Device & IVDs that includes registration with EMA, licensing, EU-MDR Transition, Classification, Dossier Review, Compilation & Submission, CE mark & ISO 13485 certification, provides support to certify medical devices from TUV, DQS, DEKRA, SGS in Germany region – Freyr Webpage Link – Medical Device Registration in Germany Freyr Expertise European Medical Device Classification ISO 13485 Compliance CE Technical File or Design Dossier Review, Compilation and Submission EU-MDR Transition and Support Clinical Evaluation Reports (CER) for Medical Devices ISO 14971 Risk Management Consulting Medical Device Regulatory Strategy Report Testing Support- Biocompatibility, Electrical Safety and Mechanical & Performance Labeling and GMP Support Post-market Monitoring and Adverse Event Reporting European Authorized Representative Support
Read more

Health Authority Queries – Responses | Interactions

The appropriate and timely communication with Health Authorities (HAs) is a key factor for the speedy approval and uninterrupted commercialization of a medicinal product either during initial approval or during Life Cycle Management (LCM, i.e. through post approval changes submissions). When a  Marketing Authorization Holder (MAH)  or applicant submits an initial or post approval activity application, upon evaluating the submitted data HAs may revert with their concerns or recommendations, if the submitted data is insufficient or requires any further clarification or for any further commitments post approval to ensure quality, safety and efficacy of the product. Either the Information Requests (IRs), Refuse to Review (RTR), or Request for Further Information (RFI), the expertise lies in understanding the concerns, response compilation while answering, so that it avoids further queries and delays in the approval procedures. While responding to HA queries, the communication ...
Read more