Peru’s Law 32319: The 45-Day Expedited Pathway and What It Actually Takes to Use It

2025–2026 · Pharmaceuticals & Specialty Products · Peru

Peru’s Law 32319 took effect on May 1, 2025. For companies with products approved by recognized international authorities, it introduced something the Peruvian market had not previously offered: a defined, time-bound pathway to registration for a specific category of products.

The headline (45 days) is accurate. What it doesn’t tell you is who qualifies, what the pathway still demands, and how to position now for what comes next.

What the Law Covers

Law 32319 established an expedited registration timeline for High Standard Country (HSC) products. The priority focus is specific: rare diseases, orphan conditions, and cancer treatments. This is not a broad fast-track for any product with FDA or EMA approval; the eligibility criteria matter.

The law also introduced a provision known as positive administrative silence: if DIGEMID does not respond within the established deadline, approval is considered granted. That mechanism shifts the default outcome in the applicant’s favor.

A technical requirement worth noting: products must be designed for climatic zones IV-A or IV-B to qualify.

Which Authorities Are Recognized

The pathway recognizes approvals from the FDA, EMA, Health Canada, Japan, Australia, and Switzerland. The required documentation includes a certificate of free sale, a risk management plan, and Spanish-language labeling.

The 45-day clock starts when you submit your application. Getting the documentation right before submission is where the timeline is actually won or lost.

Where the Pathway Stands Today

DIGEMID began processing expedited applications under the law, and the pathway was well-established by the end of 2025. Companies that moved early had an advantage not just in speed, but in building familiarity with how DIGEMID applies the new standards in practice.

For 2026 and beyond, the pathway is operational. The strategic question is no longer whether it works; it’s whether your portfolio is positioned to use it, and whether the product categories it covers today will expand.

The Strategic Calculation

For companies with qualifying products and the right reference authority approvals, Law 32319 dramatically changes the Peru entry equation. Earlier registration means earlier revenue. Reduced compliance costs change the margin math. For rare disease and oncology portfolios specifically, the combination of expedited access and positive administrative silence removes two traditional market friction points.

For companies whose products fall outside the current eligible categories, the law is still worth tracking. Potential expansion to additional product categories beyond the current scope is a development to monitor through 2026 and into 2027.

Rebexa monitors regulatory developments across 16+ markets in real time. If you have questions about whether your products qualify under Law 32319 or how to structure a submission to DIGEMID, contact us.