New Ordinance and INFARMED Informative Note set access rules and procedures
Don’t miss our content
SubscribeOrdinance No. 82/2025/1, dated March 4, establishes an exceptional reimbursement scheme for health technologies related to enteral nutrition, aimed at beneficiaries of the National Health Service (SNS) who require this type of nutritional support. The INFARMED Informative Note No. 091/CD/100.20.200, dated July 30, 2025, details the procedures and access conditions for this new scheme, clarifying operational aspects relevant to healthcare professionals, manufacturers, distributors, and patients.
Scope and Objectives
The exceptional scheme covers enteral and modular formulations for enteral nutrition, with the objective of ensuring access to essential products for patients who, for clinical reasons, cannot meet their nutritional needs through conventional food intake. The measure aims to standardize access, reimbursement, and prescription criteria, promoting equity within the SNS.
Reimbursement Rates
State reimbursement will be progressive, according to the following schedule:
- During 2025: 37% of the maximum retail price (MRP) approved by INFARMED;
- From January 1, 2026: 69%;
- From January 1, 2027: 90%.
These rates apply to both enteral formulations (products with a volume equal to or greater than 250 ml) and modular formulations (products containing only one macronutrient or component, such as proteins, carbohydrates, fats, or fiber).
Definitions and Covered Products
- Enteral nutrition: A clinical feeding method that uses the gastrointestinal tract, orally or via tube, to partially or fully meet the patient’s nutritional needs.
- Enteral formulations: Clinical nutrition products administered orally, by tube, or stoma, with a volume equal to or greater than 250 ml.
- Modular formulations: Products containing only one macronutrient or component.
- Oral nutritional supplements: Products with a volume less than 250 ml, used when the patient’s food intake is insufficient. These supplements are not yet covered by the scheme, but the ordinance foresees the possibility of future reimbursement, following evaluation and monitoring of the use of enteral and modular formulations.
Prescription and Dispensing
Prescription of these products is restricted to medical specialists in medical oncology, internal medicine, endocrinology-nutrition, gastroenterology, and pediatrics. Dispensing is carried out exclusively in community pharmacies, ensuring traceability and pharmaceutical follow-up.
Reimbursement Procedures
The reimbursement request must be submitted to INFARMED by the manufacturer or representative, accompanied by specific documentation, including:
- Identification of the applicant, manufacturer, importer, and distributor;
- Commercial name of the product, labeling, and proposed MRP;
- Clinical studies, if applicable;
- Notification number to the Directorate-General for Food and Veterinary (DGAV).
INFARMED has 20 working days to review the application, and may request additional information. The applicant has 10 working days to respond. The process may be summarily rejected if requirements or deadlines are not met. The decision is notified electronically to the applicant, and the inclusion or exclusion of products is published by INFARMED. The start, suspension, or cessation of commercialization must be communicated by the applicant.
Pricing and Commercial Conditions
Covered products are subject to a maximum retail price (MRP) approved by INFARMED. Price variations are allowed, provided they do not exceed the approved MRP.
Technical Specifications and Monitoring
The Shared Services of the Ministry of Health, INFARMED, and the Central Administration of the Health System must issue, within a maximum of 90 days, the technical specifications necessary for the prescription and dispensing of the reimbursed health technologies.
Don’t miss our content
Subscribe