Paraguay Temporary Use Authorization: Unregistered Product Imports under Resolución 203/2025

1. Key takeaways

1. Resolución DINAVISA N° 203/2025 (June 3, 2025) regulates the import of medicines and medical devices, addressing situations of temporary use authorization for products that do not hold a Paraguayan sanitary registration. It is an exceptional instrument, not a second door into the ordinary market.
2. The applicable situations are the prevention, management or control of epidemics, pandemics, public health emergencies, disasters or other exceptional situations posing a serious risk to human health or life. The trigger is a public health necessity, not a commercial timetable.
3. This channel is a supplement to, not a substitute for, ordinary registration: devices intended for ordinary commercial sale in Paraguay must still obtain a sanitary registration certificate or an NSO under Resolución DINAVISA N° 226/2024.
4. Article 3 of the resolution was the subject of a draft amendment in public consultation in 2026, which shows that this rule itself is still in adjustment; the officially published text is the only reliable reference (a practical estimate based on the public consultation information).

2. Legal basis

The three instruments occupy adjacent but distinct spaces. Ley N° 6788/2021, at Article 5 inc. b, is the source of DINAVISA’s competence over the sector. Resolución N° 203/2025, dated June 3, 2025, governs the exceptional import of unregistered products for temporary use in defined emergency situations. Resolución N° 226/2024 governs the ordinary market authorization, including the registration mandate of Articles 5 and 7 and the cost allocation rule of Article 29, under which, in the absence of a certificate, testing costs are borne by the importer or the manufacturer. A project touching unregistered product imports must be mapped against all three.

The applicant profile confirms the emergency character of the instrument. The requests under this type of authorization typically originate from health institutions or specialist physicians acting for identified patients or identified public health needs, and the resulting document is an import authorization for temporary use rather than a registration certificate with a 10-year validity. Nothing in the file converts into ordinary market access: the product still holds no sanitary registration at the end of the process, and any commercial ambition for the same product must run through the ordinary pathway of Resolución N° 226/2024, with its own application, its own review and its own fees, from the beginning.

3. Expert insights

Insight one: the temporary use authorization addresses urgent clinical need, not market access. The applicants for this type of channel are typically health institutions or specialist physicians acting for specific patients, and the scope covers individual cases or urgent public health needs. Using this channel as a way to start selling first and complete the registration later collides directly with the registration mandate of Resolución N° 226/2024 and with the cost allocation rule of Article 29, under which, in the absence of a certificate, the costs of testing are borne by the importer or the manufacturer. The economics of that exposure reverse any perceived speed advantage within a single consignment.

Insight two: the relationship with Resolución N° 226/2024 is parallel, not overlapping. Resolución N° 203/2025 deals with the import and temporary use of products without a registration certificate; Resolución N° 226/2024 deals with ordinary market authorization. The applicants, the documentation and the resulting documents differ between the two, and neither instrument can be cited as the compliance basis under the other. Mixing the two frameworks in one project creates exposure under both: the emergency file does not legitimize commercial sale, and the commercial file does not accelerate an emergency import.

Insight three: this rule is in flux and is a regulatory development requiring continuous tracking. The draft amendment to Article 3 entered public consultation in 2026, which means the conditions of application may change. Projects involving this channel must verify the latest published version of the text before starting, and any interpretation based on the earlier wording should be treated as pending verification until confirmed against the revised text. For a channel that exists to solve emergencies, regulatory certainty about its own terms is the scarce resource, and monitoring it is part of the project plan rather than an afterthought.

4. Practical recommendations

1. Position the temporary use authorization strictly as a contingency instrument; ordinary commercial projects should continue to be planned under Resolución N° 226/2024, with the emergency channel reserved for genuine necessity.
2. For projects involving urgent public health needs, first verify the latest version of Resolución N° 203/2025, including whether Article 3 has been revised following the consultation, and record the version relied upon.
3. Organize the application material around the urgent necessity and the technical and regulatory evidence for the product, and allow for the possibility of supplementary review by an expert committee, which extends the timeline beyond the applicant’s control.
4. Where the product has no registration certificate, clarify in advance which party bears the testing costs under Article 29 of Resolución N° 226/2024, and document the allocation to avoid later disputes between importer and manufacturer.

5. Verification checklist

• □ Confirmed that the project is not an ordinary sale situation (otherwise, proceed by registration under Res. 226/2024)
• □ Latest text of Resolución N° 203/2025 obtained, with the version recorded
• □ Verified whether Article 3 has been revised following the 2026 consultation
• □ Application material includes the urgent necessity and the technical and regulatory evidence for the product
• □ Bearer of the testing costs identified and documented (no-certificate scenario, Article 29)

Regulatory information verified as of October 29, 2026.

GRZAN provides registration support for manufacturers, importers and authorized representatives in Paraguay, covering emergency use pathways, import compliance and registration planning under Resoluciones N° 203/2025 and N° 226/2024. Contact: info@grzanglobal.com