Legal & Regulatory > Portugal

Part of PharmaBoardroom’s new country-focused series on market access and health technology assessment (HTA), this piece gives the lowdown on post-market approval processes and regulations in Portugal. Buy The Pharma Legal Handbook: Market Access & HTA – Portugal here for £359.   What are the pricing principles and processes in your country? Prices of medicinal products are regulated by the System of Assessment of Health Technologies (SiNATS), approved by Decree-Law 97/2015, 1 June 2015, which established the provisions applicable to pricing,…

Key legal info on biosimilars & biologics in Portugal. Prepared in association with Cuatrecasas, a leading Iberian law firm, this is an extract from The Pharma Legal Handbook: Portugal, available to purchase here for GBP 99.     1. Are biosimilar medicines considered the same as generic medicines in your country? Biosimilar medicines are defined by exclusion, i.e. a biosimilar medicine is a biological medicine which does not fulfil the conditions of the definition of a generic medicine (amongst other,…

Want to know more about localization in Portugal? Prepared in association with Cuatrecasas, a leading Iberian law firm, this is an extract from The Pharma Legal Handbook: Portugal, available to purchase here for GBP 99.     1. Are there any rules or regulations requiring and/or encouraging localization in your country? What is the legal framework defining these localization rules and policies? Generally, in the pharmaceutical sector, there are no rules and policies requiring localization in Portugal. However, it is…

An intro to the legal situation for orphan drugs and rare diseases in Portugal. Prepared in association with Cuatrecasas, a leading Iberian law firm, this is an extract from The Pharma Legal Handbook: Portugal, available to purchase here for GBP 99.     1. What is the definition of Rare Diseases in your country? There is no legal definition for Rare Disease within the national legislation. However, within the European Union, diseases that affect less than five in ten thousand…

All legal aspects surrounding cannabinoid drugs, medicinal cannabis and opioid drugs in Portugal. Prepared in association with Cuatrecasas, a leading Iberian law firm, this is an extract from The Pharma Legal Handbook: Portugal, available to purchase here for GBP 99.   Cannabinoid Drugs 1. Are Cannabinoid Drugs authorized in your country? The placing in the Portuguese market of products or substances based on cannabinoid drugs for medicinal purposes is subject to a specific authorization from Infarmed – National Authority on…

Regulatory reforms to watch out for in Portuguese pharma. Prepared in association with Cuatrecasas, a leading law firm in Portugal, this is an extract from The Pharma Legal Handbook: Portugal, available to purchase here for GBP 99.     1. Are there proposals for reform or significant change to the healthcare system? As far as publicly made available by the Portuguese Government and Parliament, there is no proposals for reform or significant changes to the healthcare system. In any case, with respect…

Read all about the legal situation around patents and trademarks in Portuguese pharma. Prepared in association with Cuatrecasas, a leading law firm in Portugal, this is an extract from The Pharma Legal Handbook: Portugal, available to purchase here for GBP 99.     1. What are the basic requirements to obtain patent and trademark protection? The main Portuguese legal framework for industrial property rights is enshrined in the Industrial Property Code (CPI), as approved by Decree-Law 110/2018, of 10 December 2018 (as…

A brief overview of the situation regarding product liability in Portuguese pharma. Prepared in association with Cuatrecasas, a leading law firm in Portugal, this is an extract from The Pharma Legal Handbook: Portugal, available to purchase here for GBP 99.     1. What types of liability are recognized in your jurisdiction? The Portuguese legal system provides for two fundamental types of civil liability: liability arising from failure to comply with contractual obligations (contractual liability) and liability resulting from the infringement of…

Want to know more about traditional medicines and OTC products in Portugal? Read on! Prepared in association with Cuatrecasas, a leading law firm in Portugal, this is an extract from The Pharma Legal Handbook: Portugal, available to purchase here for GBP 99.     1. What are the regulatory requirements for traditional, herbal, complementary, or alternative medicines and devices? Traditional, herbal, complementary, or alternative medicines are subject to a registration procedure before Infarmed. The registration procedure may be national, based on a…

All about marketing, manufacturing, packaging and labeling and advertising of drugs in Portugal. Prepared in association with Cuatrecasas, a leading law firm in Portugal, this is an extract from The Pharma Legal Handbook: Portugal, available to purchase here for GBP 99.     1. What is the authorization process for the marketing of new drugs, biologics, medical devices, over-the-counter medications, and other medicinal products? (i) Medicinal products The marketing of any medicinal products, including new drugs, biologics and over-the counter medicinal products,…

Preclinical and clinical trials in Portugal – a legal guide. Prepared in association with Cuatrecasas, a leading law firm in Portugal, this is an extract from The Pharma Legal Handbook: Portugal, available to purchase here for GBP 99.     1. Are clinical trials required to be conducted locally as a condition (stated or implicit) for marketing approval? No, clinical trials may be conducted abroad. In those cases, and whenever clinical trials are conducted outside the European Union, the applicant of the…

The key legal info around regulation, pricing and reimbursement in Portuguese pharma. Prepared in association with Cuatrecasas, a leading law firm in Portugal, this is an extract from The Pharma Legal Handbook: Portugal, available to purchase here for GBP 99.     1. What are the regulatory authorities with jurisdiction over drugs, biologicals, and medical devices in your country? Jurisdiction over drugs, biologicals and medical devices is centralized in Infarmed, the Portuguese Medicine Regulatory Authority (Autoridade Nacional do Medicamento e…

Joana Silveira Botelho of Cuatrecasas argues for the need for an EU-wide regulatory update on the advertising of pharmaceutical products online, given current rules do not take into account the spread and influence of social media today.   Today’s internet is so much more than a company’s website It is undeniable that the internet has changed the world. It is also undeniable how little laws have changed to accommodate the internet and the new reality that emerged from its foundation.…