Source: http://www.ptcrin.pt/p61-regulatory-pt
Timestamp: 2017-08-19 15:03:12
Document Index: 543146977

Matched Legal Cases: ['Art 25', 'Art 26', 'Art 26', 'Art 18', 'Art 19', 'Art 22', 'Art 22']

Regulatory - PTCRIN - Universidade Nova de Lisboa
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This database contains the Portuguese regulatory clinical trial information. It includes contact addresses of national authorities, national legislation and documents.
Study Specific Requirements
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
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.
Submission/ Notification
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:
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
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 €
(Status 2014/ Fees are being revised annually)
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).
Timelines (Submission & Approval)
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.
(Co-) Sponsorship
It is mandatory to have a sponsor. Co-sponsorship is not allowed.
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:
Quality Assurance /Quality Control (QA/QC) in the centers
Monitoring - Center Option (not mandatory) Audit by Sponsor - Center Option (not mandatory) Standard Operating Procedures (SOPs) - Center Option (not mandatory)
AE reporting/ Safety
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)
Ethical Review - General
Single-Centre Studies - Ethical Review
(1) Law 21/2014 on clinical research (pt) published 16 April 2014 in Diário da República/ Lei n.º 21/2014, of 16th of April. This law repeals Law 46/2004 of 19 August 2004 (Clinical Trials on Medicinal Products for Human Use) that incorporated the principles of the Clinical Trials Directive 2001/20/EC. This law covers all clinical research with humans including not only clinical trials with IMP but also investigations with MD and all kind of observational studies. It also regulates the organization of the Comissão de Ética para a Investigação Clínica / National Ethics Committee for Clinical Research (CEIC ). Law 73/2015 of 27th July is an amendment to Law 21/2014 and sets the conditions in which monitors, auditors and inspectors have access to the registries of clinical studies’ participants.
(3) Data Protection Act – Act 67/98 of 26 October (en)/ Lei n.o 67/98- Lei da Protecc?a?o de Dados Pessoais (pt)
There is no specific Portuguese law for orphan diseases. We follow the European regulation for orphan Diseases and their human medicines (e.g. EC 141/2000).
There are however specific Portuguese ministry of health lists of orphan drugs not for investigational purposes, but for reimbursement.
A list of applicable Portuguese legislation is available on the
INFARMED website via: Medicamentos Uso Humano> Ensaios Clinicos> Normativos de referência – Nacional: Legislação nacional aplicável)
IMP Definition:
An “investigational medicinal product” (IMP) is a pharmaceutical form of an active substance or placebo being tested or used as a reference in a clinical trial, including products already with a marketing authorization but used or assembled (formulated or packaged) in a way different from the authorised form, or when used for an unauthorised indication, or when used to gain further information about the authorised form.
Medicinal products with a marketing authorisation (MA) are classified as IMPs when they are to be used as the test substance or reference substance in a clinical trial, provided they are used or assembled (formulated or packaged) in a way different from the authorised form, or used for an unauthorised indication, or used to gain further information about the authorised form. On this basis, provided that the requirement(s) are met, reference products used as comparators should be considered as IMPs.
ECRIN CAMPUS is a central resource for information about International clinical trial regulatory and ethical requirements covering 26 European countries. Please visite ECRIN CAMPUS.