NLClinicalTrialsIMP object
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
Amendment Lei n.º 73/2015 (auditors, monitors, inspectors – access to clinical trial registries)
ad Law 21/2014: 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.
Insurance:
- General Liability Insurance Law, DL 72/2008 (pt): Art 137-148 provides the legal requirements of the insurance contract.
- Norma Regulamentar n.º14/2008-R (de 27 de Novembro) is a liability law for mandatory insurance (applicable to many cases including clinical trials).
Orphan diseases:
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.
NB! Up until April 2014, the procedure for submitting and requesting an approval of a clinical trial in Portugal was governed by Law 46/2004 of 19 August 2004. This law was revoked by Law 21/2014, of 16 April 2014, which introduced some new considerations that sponsors have to be aware when seeking to conduct clinical trials in Portugal.
Both laws incorporate the principles of the Clinical Trials Directive 2001/20/EC. It is worth noting that while Law 21/2014 introduced new procedures for submitting a clinical trial authorization request, some of the procedures are still not fully operational. Thus, some of the principles of previous law are still in use.
