The Early Access Programme (Programa de Acesso Precoce, PAP) and the Exceptional Use Authorisation (Autorização de Utilização Excecional, AUE) are the mechanisms that allow patients in Portugal to be treated with medicines that do not yet have a marketing authorisation in the country, or that have one but still have no reimbursement decision by the National Health Service (SNS).
They exist for situations where there is no satisfactory therapeutic alternative and the patient cannot wait for the assessment to finish. The PAP is requested by the company, the AUE by the hospital, and the two work together.
What is the Early Access Programme (PAP)?
The PAP is an authorisation from INFARMED, the Portuguese medicines authority, for a medicine to be used before its marketing authorisation or its pricing and reimbursement assessment is complete. The current rules were approved by INFARMED Deliberation no. 80/CD/2017 and cover two cases:
- Medicines without a marketing authorisation in Portugal, intended to treat, prevent or diagnose rare, serious or extremely debilitating diseases when no satisfactory authorised alternatives exist. Efficacy and safety must be shown by previous clinical trials, with a benefit-risk balance that can be presumed favourable.
- Medicines with a marketing authorisation, or a new indication, but no reimbursement decision in the SNS. From the date of authorisation and during the legal period of the prior assessment, supply under an AUE takes place within a PAP.
Medicines under a PAP are for hospital use only. Investigational medicines in clinical trials, magistral preparations, homeopathic and traditional herbal medicines are excluded.
What is the Exceptional Use Authorisation (AUE)?
The AUE is the authorisation, granted by INFARMED, to use a medicine in a specific patient, under article 92 of the Portuguese Medicines Statute (Decree-Law no. 176/2006). It is requested by the clinical director of the SNS hospital where the medicine will be used, with prior approval of the hospital board and an opinion from the pharmacy and therapeutics committee.
By requesting an AUE, the hospital commits to follow the approved conditions of use, inform the patient and obtain informed consent, report adverse reactions and record all information collected during treatment.
Who applies, and to whom
- PAP. The holder of the rights to the medicine, or the marketing authorisation holder, applies to the INFARMED Board. The application states, among other things, the target population, the maximum number of patients and the duration of the programme.
- AUE. The hospital applies to INFARMED, patient by patient, within the conditions of the approved PAP.
INFARMED has 5 days to approve the PAP or ask for clarifications. The applicant has 5 days to reply and INFARMED a further 5 days to decide. For authorised medicines, in proven urgency due to an imminent risk to life, justified by the hospital, these deadlines are reduced to 24 hours.
Who pays for the medicine?
As a rule, medicines under a PAP are supplied to the hospital by the rights holder free of charge to the SNS. For authorised medicines awaiting the prior assessment, the free-of-charge period is capped at 105 or 210 calendar days, depending on the case set out in the law. After that, the purchase and supply conditions are agreed between INFARMED and the company, and the PAP continues until the assessment is complete.
For companies, this means the PAP has a real cost that should be included in launch planning and in the budget impact estimate. See our guide to budget impact analysis in Portugal.
How long does a PAP last?
- For medicines without a marketing authorisation, the authorisation expires after 6 months or when the maximum number of patients is reached, unless a longer period has been approved.
- For medicines with a marketing authorisation, it ends when the prior assessment deadlines expire or when there is a final reimbursement decision.
INFARMED publishes the approved PAPs every month, with the medicine, the target population and the number of patients included. We analysed every decision since 2017 on our early access data page.
What about the new SiNATS?
Decree-Law no. 118/2026, of 17 June, established a new regime for the National Health Technology Assessment System (SiNATS), in force since 1 July 2026. Pending procedures continue under the previous rules, and the regulations for the new regime are being prepared. Until they are published, the rules that apply to early access should be confirmed case by case. Read our article on what changes with the new SiNATS.
Frequently asked questions
Does the PAP replace the reimbursement assessment?
No. The PAP allows patients to be treated while the assessment is ongoing, but it does not replace the prior assessment or the reimbursement decision.
Can a patient apply directly for a medicine under a PAP?
No. The AUE is requested by the SNS hospital where the patient is treated, through its clinical director, within the conditions of the PAP approved by INFARMED.
Does the PAP apply to medicines in clinical trials?
No. Investigational medicines covered by the clinical research law are excluded from the PAP rules.
Final thoughts
The PAP and the AUE bridge the gap between the approval of a medicine and the reimbursement decision, for patients with no alternative. For the company, a well-planned PAP brings forward access and builds experience of use in Portugal. A poorly planned one can weigh on the launch budget and on the negotiation with INFARMED.
At Clevidence, we support companies with their market access strategy in Portugal, including the feasibility of early access, the preparation of the prior assessment and the reimbursement dossier. See our integrated support for the HTA process and financing in Portugal, or learn more about our HTA and market access services.