Local compliance support for pharmaceutical and biotech companies working in Portugal, covering INFARMED transparency declarations, advertising rules and the APIFARMA code, with a named Portuguese business partner.
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Local expertise · Global delivery
For pharmaceutical and biotech companies with Portuguese activities, regional teams covering Iberia or Lusophone markets, and companies setting up their first Portuguese operations. Start with the entities involved and the economic advantages they grant or receive.
Portugal's transparency obligation is statutory and applies to any entity working in the medicines circuit, with declarations made through INFARMED's platform. Companies used to annual code-based disclosure need a process that captures each benefit as it is granted and declares it within 30 days, with evidence, rather than one year-end report. Recipients then validate the entries, so recipient data must be accurate.
From requirements to action
With local input from our Portugal-based partner, we can map your activities against Article 159 of the Estatuto do Medicamento, INFARMED advertising requirements and the APIFARMA code, and build the declaration process into your approval and payment workflows. Outputs can include an activity register, a responsibility matrix and a prioritised action plan. Where Portuguese legal advice is required, we identify that need before delivery.
What we can take on
What this gives you
Portugal requirements built into your global processes
A named local partner for questions and escalation
Local support without unnecessary fixed headcount
The rules in Portugal
A short guide to the main legal and self-regulatory frameworks. Each summary links to its official source below.
Decreto-Lei n.º 176/2006 (the Estatuto do Medicamento) sets the advertising rules in Chapter IX (Articles 150–164). Advertising prescription-only medicines to the general public is prohibited, as is public advertising of narcotic or psychotropic medicines and of medicines reimbursed by the SNS (Article 152). Prescription-only medicines may be advertised only in technical publications or media intended for, and accessible only to, healthcare professionals (Article 154).
INFARMED, Portugal’s national authority for medicines and health products, registers and assesses medicines advertising. Companies must send INFARMED a copy of each advertisement within 10 days (Article 164).
Companies and wholesalers may not give healthcare professionals prizes, gifts or benefits, except items of insignificant value that are relevant to the practice of medicine or pharmacy, and healthcare professionals may not ask for or accept them (Article 158). Fees for active participation, such as presentations, are allowed if they are not linked to prescribing. Hospitality at scientific events is limited to registration, travel and accommodation, from the day before to the day after the event (Article 161).
Any entity covered by the Estatuto must report any benefit it grants to any person or organisation, including healthcare professionals, SNS staff, patient associations and scientific societies, on INFARMED’s website within 30 days of granting it (Article 159(5)). A benefit means any advantage, value, good or right that can be valued in money. Sponsoring an event must be notified to INFARMED in advance, and event records kept for five years.
Declarations are made through INFARMED’s Plataforma de Comunicações – Transparência e Publicidade, used both to report benefits granted and to validate benefits received. Recipients are notified and have 30 days to confirm or dispute an entry; if they do nothing it is treated as tacitly valid. The resulting public listing is published immediately and automatically.
APIFARMA’s Código Deontológico covers promotion and interactions with healthcare professionals and healthcare organisations. The current version was approved on 25 November 2022 and has applied since 1 January 2023. Patient organisations are covered by a separate APIFARMA code of conduct. The Conselho Deontológico, made up of three independent people elected by the General Assembly, enforces the code, and sanctions are published.
Your local partner
Jalmira Mulchande is a healthcare consultant based in Portugal and the Co-founder and General Manager of Xtrategical Pharma Consulting. A pharmacist and global health advocate with a PhD, she brings over 15 years of experience spanning health policy, regulatory and medical affairs, ethical and legal compliance, health technology assessment, and patient access to innovative health technologies.
This overview is informational and does not constitute legal advice. Scope and application should be confirmed for the organisation, market, activity and counterparty in question. Sources checked September 2026.
Questions, answered
Under Article 159 of the Estatuto do Medicamento, any benefit granted to a person or organisation, including healthcare professionals, must be reported on INFARMED’s platform within 30 days of granting it. Event sponsorship must be notified in advance.
Yes. Recipients are notified and have 30 days to confirm or dispute the entry on INFARMED’s platform. If they do not respond, the entry is treated as tacitly valid.
Only items of insignificant value that are relevant to the practice of medicine or pharmacy (Article 158). Any benefit granted must still be declared under Article 159.
No. The APIFARMA code requires disclosure of transfers of value under national law, so the 30-day declaration rule in Article 159 applies.
Yes. We map Portuguese requirements into your global processes, with local input from our Portugal-based partner, so Portugal is handled consistently with your other European markets.
We will listen, ask a few questions and recommend the right scope—without obligation or pressure.
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