Single customs clearance and the non-extendable 150-calendar-day validity

1. Key takeaways

The easiest trap in the special import authorisation is not the documents but its boundaries in space and time. Article 75 of Acuerdo No. 0631-ARSA-2023, in its final paragraph on Disposiciones finales sobre autorizaciones sanitarias, gives 5 points, and point 1 is the hardest: a special import authorisation must be applied for separately for each import, is valid for a single customs clearance (desaduanaje) only, has a validity of 150 calendar days from the date of issue, and is non-extendable. The other four points: non-commercial storage premises must still meet the sanitary requirements guaranteeing safety, quality and effectiveness; products entering under a special authorisation are subject to inspection and supervision during and after customs clearance; ARSA may at any time require additional documents it considers necessary; and documents from abroad that are not in Spanish must be translated into Spanish. Read the processing clock together with item DÉCIMO TERCERO of Acuerdo No. 012-2020: the deadline runs from the day the application documents are complete, and where a correction is required, from the day the correction is completed.

2. Legal basis

The spatial and temporal limits of the special import authorisation come from the final paragraph of Article 75 of the regulation, while the timing mechanics come from the fee instrument. The table below consolidates the five points and the clock rules.

3. Expert insights

Insight 1: a single clearance is a quantity constraint, not a time constraint. Point 1 confines the effect of the authorisation to one único desaduanaje. The practical meaning is direct: if one shipment arrives on two flights, there are two clearances and two authorisations are needed; one authorisation cannot be stretched to cover multiple arrival batches.

Insight 2: 150 calendar days, non-extendable, is the only benchmark for back-planning logistics. The text reads ciento cincuenta (150) días calendario improrrogable, using calendar days rather than working days and stating expressly that no extension is possible. Production planning must be reverse-engineered from the date of issue: manufacturing, international transport, arrival and clearance must all fit inside the 150 days, with no fallback route of applying for an extension.

Insight 3: a correction resets the clock, the most underestimated risk. Item DÉCIMO TERCERO of Acuerdo 012-2020 provides that the deadline runs from the date the application contains all technical and legal elements, and where a correction is required, from the date of completion of the correction. Document quality therefore directly determines the cycle: an application with a missing item can turn 5 working days (AENG, item SÉPTIMO) into several weeks.

Insight 4: institutional corrections are free, a rule that can be used proactively. Item DÉCIMO PRIMERO provides that institutional corrections (correcciones institucionales) discovered by the applicant before receiving the decision notice are handled by ARSA within the original deadline and free of charge. This differs from the refusal situations of Article 87 or the sale prohibitions of Article 38; it is an error-correction window at the acceptance stage, and GRZAN proactively re-checks ARSA’s keyed-in data after filing.

Insight 5: non-commercial does not mean unregulated. Points 2 and 3 of the final paragraph make clear that non-commercial storage premises must still meet sanitary requirements and that the products remain subject to inspection and supervision during and after clearance. The special authorisation exempts the registration step, not the state of being supervised.

4. Practical recommendations

• Back-plan applications by arrival batch: one authorisation per clearance; file separately for each arrival batch and do not consolidate the declaration.
• Make the 150 calendar days a master project milestone: back-plan production, shipment, arrival and clearance from the date of issue, leaving no margin that depends on an extension.
• Run a full completeness self-check before filing to minimise the risk of a correction, since a correction restarts the processing deadline.
• After receiving the acceptance receipt, proactively verify the entity, product name and quantity data keyed in by ARSA; request a free institutional correction before the decision notice (item DÉCIMO PRIMERO of Acuerdo 012-2020).
• Submit Spanish translations of non-Spanish documents together with the application (point 5 of the final paragraph); do not wait for the correction notice.
• Where acceleration is genuinely needed, apply in writing for a shorter deadline and pay the difference under item DÉCIMO SEGUNDO of Acuerdo 012-2020, rather than chasing verbally.

5. Verification checklist

• □ Arrival batches have been counted and the number of authorisations matches the number of clearances one to one
• □ A back-plan against the 150 calendar days exists and contains no assumption of extension
• □ Application documents have passed a completeness self-check against the 9 items of Article 75
• □ Spanish translations accompany all non-Spanish documents
• □ Storage premises meet the sanitary conditions for non-commercial storage
• □ A named person tracks ARSA correction notices and decision progress
• □ Acceleration needs have been raised under item DÉCIMO SEGUNDO with the fee difference budgeted

How GRZAN can help. GRZAN provides medical device and IVD registration, quality system, authorised representative and local testing support for the Honduran market. Our team manages Secretariat of Health (SESAL) registration applications, prepares Spanish-language dossiers, and supports post-market vigilance obligations. Business enquiries: info@grzanglobal.com

Regulatory information verified as of October 29, 2026.