PORTUGAL Law and Practice Contributed by: Eduardo Nogueira Pinto, Hugo Monteiro de Queirós, Eliana Bernardo and Ricardo Rocha, PLMJ
1. Life Sciences Regulatory Framework 1.1 Legislation and Regulation for Pharmaceuticals and Medical Devices The rules on medicines for human use come from Decree-Law 176/2006 of 30 August 2006, while the rules on medical devices come from Decree-Law 189/2000 of 12 August, Decree- Law 145/2009 of 17 June, Decree-Law 29/2024 of 5 April, Regulation (EU) 2017/745 of the Euro- pean Parliament and of the Council of 5 April 2017 (the Medical Devices Regulation – MDR) and Regulation (EU) 2017/745 of the European Parliament and of the Council of 5 April 2017 (In Vitro Medical Devices Regulation – IVMDR). There are also several sets of regulations that implement decree laws in different matters. The regulatory body that applies and enforces pharmaceutical and medical device regulation is INFARMED (the National Authority of Medicines and Health Products, IP), which is part of the State’s indirect administration and is endowed with administrative and financial autonomy. It is responsible for carrying out the responsibilities of the Ministry of Health under the supervision and guidance of the Minister of Health. As a rule, the Minister of Health takes decisions regarding expenditure on medicines and medi- cal devices, who may delegate these decisions to INFARMED. 1.2 Challenging Decisions of Regulatory Bodies That Enforce Pharmaceuticals and Medical Devices Regulation INFARMED’s decisions regarding medicines and medical devices may be challenged through administrative and/or judicial channels within a given period.
Individuals and entities affected by these deci- sions can react against them, mainly on the grounds of breach of the law. These means of reaction are common to decisions that affect other products (eg, food supplements and cos- metics), although there may be specific details. 1.3 Different Categories of Pharmaceuticals and Medical Devices Certain categories of medicines and medical devices are subject to specific regulations. As an example, medicines containing psycho- tropic and narcotic substances are regulated by Decree-Law 15/93 of 22 January 2022, Decree-Regulation 61/94 of 12 October 1994, Law 33/2018 of 18 July 2018 and Decree-Law 8/2019 of 15 January. Different pieces of legislation regulate clinical tri- als of medicines and clinical studies of medical devices. Medicines Regulation regulates clinical trials of medicines (EU) 536/2014 of the European Parliament and of the Council of 16 April 2014 (“Clinical Trials Regulation” ) and Law 21/2014 of 16 April 2014 (“Clinical Trials Law” ). The entry into force of the Clinical Trials Regula- tion on 31 January 2022 involved the entry into force of the Clinical Trials Information System (CTIS), through which all clinical trial submission, assessment and supervision processes in the EU are to be submitted. The three-year transition period provided by the Clinical Trials Regulation has elapsed on 31 January 2025, after which all 2. Clinical Trials 2.1 Regulation of Clinical Trials
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