FAQs

 

1- What is the scope of Law No 9/2026 of 6 March?

Law No 9/2026 of 6 March has as its main scope the regulation of clinical trials of medicinal products for human use in Portugal, ensuring the direct and operational application of the European legal framework in this area.

This Law ensures the implementation, within the domestic legal order, of Regulation (EU) No 536/2014, relating to clinical trials of medicinal products for human use, which has become the central regime applicable in the European Union. Law No 9/2026 of 6 March also establishes the legal regime applicable to the procedures for authorisation, assessment, conduct, modification and supervision of clinical trials of medicinal products for human use in national territory.

It amends the Clinical Research Law (Law No 21/2014 of 16 April), introducing its third amendment, in order to align it with the new European clinical trials regime.

 

2- What is the date of entry into force of Law No 9/2026 of 6 March?

Law No 9/2026 of 6 March entered into force on 5 April 2026.

 

3- What changes did Law No 9/2026 of 6 March introduce to Law No 21/2014 of 16 April?

Law No 9/2026 removes clinical trials with medicinal products for human use from the scope of Law No 21/2014, which are now regulated:

  • Directly by Regulation (EU) No 536/2014
  • And by Law No 9/2026 itself

Law No 21/2014 now applies essentially to:

  • Observational studies with medicinal products
  • Clinical research not covered by Regulation (EU) No 536/2014
  • Trials and studies with medical devices and other health products, where applicable.

 

4 - What is the scope of the Law no. 21/2014 of 16 April?

The Law No. 21/2014 of 16 April establishes the legal framework for conducting clinical studies in Portugal, regulating all clinical research activity understood as the systematic study aimed at discovering or verifying the distribution or effect of health factors, health states or outcomes, health or disease processes, as well as the performance and/or safety of interventions or the provision of healthcare.

Its scope includes, in particular, non-interventional clinical studies (observational studies), clinical research on medical devices, resulting from the partial transposition of Directive 2007/47/EC of the European Parliament and of the Council of 5 September, as well as other forms of clinical research in human beings not covered by directly applicable European legislation.

Following the entry into force of Law No 9/2026 of 6 March, clinical trials of medicinal products for human use are now regulated by Regulation (EU) No 536/2014 of the European Parliament and of the Council, and by the aforementioned Law No 9/2026, and are no longer within the substantive scope of Law No 21/2014. The latter nonetheless retains full application to all other forms of clinical research.

Law No 21/2014 duly repealed Law No 46/2004 of 19 August with regard to the national clinical research framework.

 

5 - What is the date of entry into force of the Law no. 21/2014 of 16 April?

The Law no. 21/2014 of 16 April, entered into force on the 16th of June 2014.

 

6 - What does the meaning of "clinical study" in the context of the Law no. 21/2014 of 16 April?

For the purposes of the Clinical Investigation Law:

The term "clinical studies" includes:

- "Non-interventional clinical studies" and

- "Interventional clinical studies"

The term "interventional clinical studies" includes (in addition to others not specified) as follows:

  1. "Clinical trials" and
  2.  "Interventional clinical studies with medical devices" and "clinical studies with cosmetics products".

 

7- What is required to conduct a clinical trial in Portugal in accordance with Regulation (EU) No 536/2014 and Law No 9/2026 of 6 March?

Clinical trials of medicinal products for human use are subject to prior authorisation by INFARMED - National Authority of Medicines and Health Products, IP (INFARMED, IP), following the technical-scientific and ethical assessment of the clinical trial application, under the terms set out in Regulation (EU) No 536/2014 of the European Parliament and of the Council of 16 April 2014, and in Law No 9/2026 of 6 March.

 

8- What are the timelines for the approval of clinical trials by INFARMED, I.P. and the timelines for the issuance of an opinion by CEIC, in accordance with Regulation (EU) No 536/2014 and Law No 9/2026 of 6 March?

The timelines for the assessment of a clinical trial application under Regulation (EU) No 536/2014 are harmonised throughout the European Union through the CTIS (Clinical Trials Information System).

The standard assessment process typically takes up to 60 days, although this period may be extended if requests for additional information (RFI) are issued.

 

9 - How to submit clinical trials applications and notifications to INFARMED and CEIC, following the entry into application of Regulation (EU) No 536/2014 and Law No 9/2026 of 6 March?

The Clinical Trials Information System (CTIS) is the single entry point for the submission of information relating to clinical trials in the European Union (EU) and the European Economic Area (EEA).

 

10 - How is the procedure for record and notification of adverse reactions and events laid down in Article 18 of Law No 9/2026 of 6 March?

Notifications relating to the progress of the trial, the safety of participants, unexpected events, as well as notifications relating to trial compliance issues, must be submitted exclusively through the European portal CTIS (Clinical Trials Information System), under the provisions of Regulation (EU) No 536/2014.

 

11 - Which types of studies can I submit through RNEC electronic platform?

The submission of Clinical Studies through RNEC portal is applicable to:

A  Interventional studies with Medical Devices

B Interventional studies with cosmetic products

C Non-interventional Post Authorization Efficacy Studies (PAES)

D Non-interventional Post Authorization Safety Studies (PASS)

Only Categories A studies  should be submitted to CEIC. Studies from categories B,C and D should be submitted to the Clinical Site` s Ethics Committee (CES) according to the respective procedures.

Only when the Clinical Site does not own a local Ethics Committee (CES), Categories B, C and D studies can be submitted through RNEC portal to CEIC.

NOTE: All Studies that are submitted to CEIC outsider of the scope of its evaluation will be automatically  stored without any evaluation or associated procedure according to Law 21/2016 from April 16.