INFARMED- National Authority of Medicines and Health Products, IP/ Autoridade Nacional do Medicamento e Produtos de Saúde I.P.;
(Government agency accountable to the Health Ministy)
Health Products Directorate
Parque de Saúde de Lisboa
Avenida do Brasil, 53
1749-004 Lisboa
Portugal
Tel +351 21 798 7283
Fax: +351 21 798 7248
Email: cimi@infarmed.pt (general information on clincial trials); ensaios.clinicos@infarmed.pt (information on procedures)
Website: http://www.infarmed.pt/
(The English web pages contain selected items from its Portuguese language site and will be continuously expanded)
No local CAs.
(Government agency accountable to the Health Ministy)
Health Products Directorate
Parque de Saúde de Lisboa
Avenida do Brasil, 53
1749-004 Lisboa
Portugal
Tel +351 21 798 7283
Fax: +351 21 798 7248
Email: cimi@infarmed.pt (general information on clincial trials); ensaios.clinicos@infarmed.pt (information on procedures)
Website: http://www.infarmed.pt/
(The English web pages contain selected items from its Portuguese language site and will be continuously expanded)
The sponsor must apply for a clinical trial authorisation to the national CA (INFARMED) according to Art 25-27 Law 21/2014 (pt).
Required submission format of the application dossier:
Detailed guidance for the applicant regarding the trial submission and the definite structure of the documentation on the CD-ROM is provided on the website in section:
Medicamentos Uso Humano> Ensaios Clinicos> Submissão ao INFARMED
Required submission format of the application dossier:
- Application letter (“Carta de requerimento”) in paper format
- Confirmation of payment (in electronic format on CD-ROM)
- Standard application form: Annex 1: Clinical trial Application Form/ Formulário de pedido de AEC (in electronic format on CD ROM)
- Further documentation as specified in Art 26 (1) Law 21/2014 (pt)
Detailed guidance for the applicant regarding the trial submission and the definite structure of the documentation on the CD-ROM is provided on the website in section:
Medicamentos Uso Humano> Ensaios Clinicos> Submissão ao INFARMED
Portuguese, English accepted (for official application documents and scientific documents only; NOT for documents intended for study subjects)
Fees for the authorization of
Academic Studies: No submission fees.
Related information plus detailed guidance on the payment procedure is available on the INFARMED website in section Taxas > Ensaios Clínicos: „Guia para pagamento de taxa sobre ensaios clinico“ (in Portuguese only).
- Clinical trial Phase I-III: 1.023,00 €
- Clinical trial Phase IV: 460,35
- Studies on Bioavailability and Bioequivalence: 255,75 €
- Substantial amendment to protocol: 102,30 €
Academic Studies: No submission fees.
Related information plus detailed guidance on the payment procedure is available on the INFARMED website in section Taxas > Ensaios Clínicos: „Guia para pagamento de taxa sobre ensaios clinico“ (in Portuguese only).
Approval timeline: 30 days
One clock stop is possible if CA requests complementary information or documentation from applicant. INFARMED usually sends an email confirmation and a letter.
+20 days: for clinical trials involving gene therapy, somatic cell therapy, GMOs.
+50 days: if additional consultation and involvement of a qualified expert committee is required No time limit: for clinical trials involving xenogeneic cell therapy medicinal products.
Explicit authorization might be necessary for clinical trials involving gene therapy, somatic cell therapy, GMOs xenogeneic cell therapy Respective timelines for CA approval is provided in Art 26 & 77 of Law 21/2014 (pt).
Submission to the EC, CA and Data Protection Authority can be done in any order or in parallel.
One clock stop is possible if CA requests complementary information or documentation from applicant. INFARMED usually sends an email confirmation and a letter.
+20 days: for clinical trials involving gene therapy, somatic cell therapy, GMOs.
+50 days: if additional consultation and involvement of a qualified expert committee is required No time limit: for clinical trials involving xenogeneic cell therapy medicinal products.
Explicit authorization might be necessary for clinical trials involving gene therapy, somatic cell therapy, GMOs xenogeneic cell therapy Respective timelines for CA approval is provided in Art 26 & 77 of Law 21/2014 (pt).
Submission to the EC, CA and Data Protection Authority can be done in any order or in parallel.
It is mandatory to have a sponsor. Co-sponsorship is not allowed.
Idem EC! The investigator must inform the sponsor immediately (not later than 24 hours) on the occurrence of any SAEs. A detailed written report must follow within 5 days. The sponsor shall ensure that any SUSARS being fatal or life-threatening are reported to the competent EC, the national CA and the CA of any EEA State in which the trial is being conducted, not later than 7 days after sponsor’s first knowledge All other SUSARS are reported to the competent EC, the national CA and the CA of any EEA State in which the trial is being conducted as soon as possible and in any event not later than 15 days after the sponsor is first aware of the reaction. The reporting timelines are provided in Art 22 Law 21/2014 (pt). An Annual Safety report shall be submitted to the competent EC and the national CA by the sponsor pursuant to Art 22 (10) Law 21/2014 (pt)
The sponsor has to submit any substantial amendments to the study protocol to the CA, pursuant to Art 18 Law 21/2014 (pt). Standard notification form to be used by the applicant for submission of substantial amendments is provided on the INFARMED website in section: Medicamentos Uso Humano> Ensaios Clinicos> Formulários: “Substantial Amendment Notification Form (pdf)”/ “Formulário de pedido de alteração (pdf)”
The sponsor is obliged to notify the competent EC and the national CA of the end of the trial within 90 days (counted form last visit of study participant). Premature trial termination must be declared within 15 days with clearly stating the reasons for it. (Art 19 Law 21/2014 (pt)) The standard notification form (“Declaration of the End of Trial Form (pdf)”/ “Formulário de declaração de fim de EC”) to be used for declaration of the end of a clinical trial to the CA and the EC is provided on the INFARMED website in section Medicamentos Uso Humano> Ensaios Clinicos> Formulários:
Monitoring - Center Option (not mandatory) Audit by Sponsor - Center Option (not mandatory) Standard Operating Procedures (SOPs) - Center Option (not mandatory)
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