On 6 March, Law no. 9/2026 ("Law") was published, setting-forth the regime for clinical trials of medicines for human use and implementing the Clinical Trials Regulation ("Regulation") in Portugal.
Although the Law maintains, in many aspects, the regime previously provided for in the Clinical Research Law ("CRL"), we highlight the following:
COMPETENT AUTHORITIES
INFARMED - National Authority of Medicines and Health Products, I.P. (“INFARMED”) and the National Ethics Committee for Clinical Research (“CEIC”) remain the competent authorities.
INFARMED is responsible for the application of the Regulation and the Law, in general terms, and is specifically tasked with authorising clinical trials, ordering their suspension or termination, as well as adopting the necessary guidelines for the application of these instruments, in coordination with CEIC.
In turn, CEIC is responsible for assessing ethical aspects associated with clinical trials, including by issuing an ethical opinion as part of the trial authorisation procedure.
INFORMED CONSENT
Rules on informed consent of participants are developed, including provisions regarding minors and incapacitated subjects. Specific rules are also enacted for emergency situations.
In cases where the patient is at serious or imminent risk and it is not possible to obtain consent in a timely manner, he/she may, on an exceptional basis, participate in the trial, provided that:
- the trial is directly related to the participant’s clinical situation and cannot be performed under other circumstances; and
- the trial protocol has prior approval from CEIC, ensuring minimal risks and a well-founded expectation of direct benefit for the participant.
Consent must, however, be obtained as soon as possible.
LIABILITY AND COMPENSATION FOR DAMAGES
The regime provided for under the CRL is essentially maintained:
- the sponsor and the investigator are jointly liable, regardless of fault, for damages caused by the trial;
- the sponsor must contract an insurance covering this liability, which should be "appropriate to the nature and extent of the risk".
- damages occurring during the trial and up to one year after its completion are presumed to have been caused by the trial, a period that may be extended by CEIC upon justification.
FREE SUPPLY AND COMPASSIONATE USE
The obligation for sponsors to provide participants, free of charge, with experimental and auxiliary medicines, medical devices used for administration, appointments and complementary diagnostic tests necessary for the trial is maintained, in line with the Regulation and the CRL.
Such an obligation is also maintained after termination of the trial, in what medicines and medical device are concerned, provided that the investigator considers the continuation of treatment by the participant indispensable and there are no therapeutic alternatives of equivalent efficacy and safety.
This obligation survives until the effective introduction of the product in the distribution chain and the guarantee of access within the NHS, under terms to be defined by an order of the Ministry of Health.
FINANCIAL CONTRACTS
Regarding contracts to be entered into between sponsors and trial sites, the Law refers to the regime set-out in the Regulation. INFARMED may, however, issue guidelines in this regard, similar to what CEIC already did under the CRL.
The Law clarifies, in line with current practice, that contracts may be entered prior to authorisation of the trial but may only be effective after said authorisation.
LANGUAGE
All documents submitted for trial authorisation applications may be written in Portuguese or English.
Information addressed to participants, including recruitment and consent materials, must be written in Portuguese, except in duly justified exceptional cases, with CEIC’s prior approval.
SANCTIONS FRAMEWORK
INFARMED is responsible for supervising and monitoring compliance with the Regulation and the Law and may inspect the sponsor's premises, trial sites, and laboratories responsible for complementary tests.
Non-compliance with the Regulation and the Law constitutes an administrative offence punishable with a fine that can range from € 5.000 to €750.000 for legal entities.
The liability of governing bodies is also provided for, subject to the same sanctions applicable to the legal entity, unless a more severe penalty is imposed to them under another legal provision. Finally, ancillary sanctions may also be applied, such as suspension or prohibition from conducting trials for up to two years.
Administrative offence proceedings are conducted by INFARMED, which is also responsible for issuing a decision.
ENTRY INTO FORCE
The Law enters into force on 5 April 2026.
