Four recent resolutions establish new procedures and requirements for medicines intended to treat rare diseases, compassionate-use imports, nicotine pouches and advanced therapy medicinal products.

Paraguay's National Directorate of Health Surveillance (DINAVISA) has issued four resolutions introducing new procedures, requirements and marketing authorization rules for pharmaceutical products and other regulated products in Paraguay.

New procedure for medicines intended to treat rare diseases

Resolution No. 391/2026, dated September 23, 2026, establishes a special marketing authorization procedure for medicines intended to treat rare diseases, defined as conditions affecting one in 2,000 people or fewer.

The procedure provides for processing periods of 60 to 180 business days, depending on the case, and a five-year validity period for the marketing authorization.

The resolution is already in effect.

New requirements for compassionate-use imports

Through Resolution No. 396/2026, dated September 25, 2026, DINAVISA introduces new requirements for companies involved in importing medicines and medical devices without marketing authorization for compassionate use.

These requirements include authorization from the manufacturer or exporter.

The resolution also establishes a 10-business-day response period.

The resolution is already in effect.

Mandatory registration for nicotine pouches

Resolution No. 412/2026, dated October 1, 2026, introduces specific regulations for nicotine pouches in Paraguay for the first time.

Its main provisions include mandatory sanitary registration, a ban on advertising and child-resistant packaging requirements.

The resolution also sets a maximum nicotine content of 16.7 mg per pouch.

It took effect on October 26, 2026.

New regulatory framework for advanced therapy medicinal products

DINAVISA has also established a regulatory framework for advanced therapy medicinal products (ATMPs), covering gene therapies, somatic cell therapies, tissue-engineered products and combined therapies.

The regulation requires marketing authorization and provides for technical evaluation periods of 90 to 180 days, depending on the case.

It also establishes patient follow-up periods ranging from 5 to 10 years.

The resolution is already in effect.