Colombia Requerimiento Response Window and Deficiency Strategy

1. Key takeaways

A requerimiento is the deficiency notice INVIMA issues during review, with a response period of 90 days (public sources vary between calendar days and business days; GRZAN treats this on a practical-estimate basis). The legal meaning of this window runs longer than its literal text: failure to respond within the window causes the application to be deemed suspended, and a continuing suspension moves toward cancellation proceedings under the administrative procedure rules of Ley 1437 de 2011 (CPACA).

GRZAN emphasizes two points. First, a deficiency is not an opportunity to resubmit materials; it is a formal procedural node at which review has already formed a preliminary judgment and demands a response, and the quality of the response directly determines how many further rounds follow. Second, the authority’s review clock is suspended during the deficiency period — the 90 business days statutory period pauses when the requerimiento issues and resumes when the response is submitted. The longer the window is used, the later the delivery, but the window itself grants preparation time. Treating the 90 days as a grace period and delaying the response is the least economical choice available.

2. Legal basis

3. Expert insights

#### The deficiency window runs in both directions: it grants time and fixes accountability

The 90-day response period is preparation time from the applicant’s perspective, but a compliance deadline from the administrative procedure perspective. If the window lapses without a response, the legal consequence is not that the application quietly keeps waiting — it is deemed suspended. GRZAN’s handling in projects: register the window’s start and end dates on the day the requerimiento arrives and build the internal preparation nodes backwards, splitting the 90 days into four segments — decoding the deficiency points, assembling evidence, finalizing the Spanish text, and the local apoderado’s review and submission. Any segment that slips squeezes the segments behind it.

#### The scarcity of deficiency opportunities means the response must be complete in one pass

Under the current approach, failing to respond within the window means suspension, and applicants are not given multiple costless deficiency opportunities. This dictates response strategy: not submitting a partial answer to probe, but mapping every deficiency point to its evidence and answering completely in a single pass. GRZAN’s position is that a deficiency response must be prepared to a final-round standard — if this round falls short, what awaits next may not be a second requerimiento but suspension and cancellation proceedings.

#### Deficiencies point mostly at consistency, not at missing documents

Items hit by a requerimiento in practice are rarely a missing file; they are mostly two statements that do not match — the premises of the classification determination conflicting with the intended use in the instructions for use, technical parameters taking different values across annexes, or the signing entity not matching the record in the power of attorney (Art. 29). This connects to the checklist-style requirements of Art. 18 and Art. 19: a checklist can be ticked item by item, but the mutual corroboration between checklists must be actively constructed. GRZAN therefore runs an independent consistency check before submission, moving the trigger points of deficiencies upstream.

#### The cost of deficiencies can be quantified in the budget

A deficiency carries more than a time cost. If responding requires substantive adjustments to the filing content, modification fees may be triggered — a technical-nature modification at COP 1,060,243 and a legal-nature modification at COP 826,546. In addition, the authority’s clock is suspended during the deficiency period and the market launch plan slips, a commercial cost that usually exceeds the official fees themselves. GRZAN recommends a dedicated deficiency-response line in the project budget, covering both possible modification fees and internal response hours plus translation costs. Without this line, the project loses the initiative on funding and staffing midway.

4. Practical recommendations

1. On the day the requerimiento arrives, the GRZAN regulatory team registers the window’s start and end dates and delivers a deficiency-point mapping sheet that annotates the corresponding Art. 18 or Art. 19 document item for every point.
2. The technical documentation lead prepares the response to a final-round standard, answering every point completely in one submission, never in exploratory batches.
3. The titular’s local apoderado reserves sufficient review time before the window closes, submits through SIRIS, and retains the submission receipt.
4. The project manager updates the schedule in parallel: the authority’s review clock is suspended during the deficiency period and resumes on submission; the delivery range is recalculated accordingly.
5. Finance adds a dedicated deficiency-response line to the budget, covering the technical-nature modification fee of COP 1,060,243, the legal-nature modification fee of COP 826,546, and internal response costs.
6. The quality team writes the deficiency points of this round back into the pre-submission consistency checklist as prevention for the same titular’s future products.

5. Verification checklist

• □ The start and end dates of the 90-day window were registered on the day the requerimiento arrived
• □ A deficiency-point mapping sheet has been delivered, annotating the document item for every point
• □ The response is prepared for single complete submission, without exploratory batching
• □ The local apoderado has reserved review time and retains the SIRIS submission receipt
• □ The schedule has been recalculated on the premise that the authority’s clock is suspended during the deficiency period
• □ The budget carries a dedicated deficiency-response line, including modification fees and internal costs
• □ Deficiency points have been written back into the pre-submission consistency checklist
• □ It has been confirmed the response introduces no new conflicts with existing documents

Regulatory information verified as of October 29, 2026

All external conclusions rest on the current regulatory texts published by the competent authority, verified provision by provision before delivery.

GRZAN manages INVIMA requerimiento responses end to end for the Colombian market — window tracking, deficiency-point mapping, Spanish finalization and SIRIS submission — so a deficiency never becomes a suspension. For inquiries, contact info@grzanglobal.com.