PORTUGAL Law and Practice Contributed by: Eduardo Nogueira Pinto, Hugo Monteiro de Queirós, Eliana Bernardo and Rúben do Carmo Pereira, PLMJ
PLMJ Av Fontes Pereira de Melo 43 1050-119 Lisboa Portugal
Tel: +351 213 197 300 Fax: +351 213 197 400 Email: plmjlaw@plmj.pt Web: www.plmj.com/en
1. Life Sciences Regulatory Framework 1.1 Legislation and Regulation 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 European Parliament and of the Council of 5 April 2017 (the Medical Devices Regula- tion – MDR) and Regulation (EU) 2017/745 of the Euro- pean 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 responsible for applying and enforcing pharmaceutical and medical device regula- tions is INFARMED (the National Authority of Medi- cines and Health Products, IP), which is part of the State’s indirect administration and is endowed with administrative and financial autonomy. It is respon- sible for carrying out the Ministry of Health’s respon- sibilities under the supervision and guidance of the Minister of Health. As a rule, the Minister of Health makes decisions regarding public funding for medicines and medi- cal devices, which may delegate these decisions to Infarmed.
1.2 Challenging Decisions of Regulatory Bodies INFARMED’s decisions regarding medicines and med- ical devices may be challenged through administrative and/or judicial channels within a given period. Individuals and companies affected by these deci- sions can challenge them, mainly on the grounds of: • breach of the law; • errors of fact; • errors of law; and • breach of procedural requirements. These means of reaction are common to decisions that affect other products (eg, food supplements and cosmetics), although there may be specific details. 1.3 Categories of Pharmaceuticals and Medical Devices Certain categories of medicines and medical devic- es are subject to specific regulations. For example, medicines containing psychotropic and narcotic sub- stances 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.
In addition, some medicines, in addition to being pre- scription-only, are subject to further restrictions, such as those for hospital use only.
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