Pharmaceutical compliance support in Portugal
Local rules, connected to your global model.
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.
Discuss this service
What we can take on
Pharmaceutical compliance in Portugal: scope of support
HCP and patient organisation engagement review
Local transparency and disclosure requirements
Promotional and non-promotional material review
Market-entry compliance assessment
Responsible person and local representative support
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
What shapes compliance in Portugal…
A short guide to the main legal and self-regulatory frameworks. Each summary links to its official source below.
Transparency: Article 159 of the Estatuto do Medicamento
Decreto-Lei n.º 176/2006 of 30 August (the Estatuto do Medicamento), as amended by Decreto-Lei n.º 20/2013 and Decreto-Lei n.º 128/2013, requires any entity working in the medicines circuit to declare any economic advantage granted or received.
INFARMED's transparency platform
Declarations are made through INFARMED's Plataforma de Comunicações – Transparência e Publicidade, which records sponsorships granted or received and produces a public listing from the declarations made.
Advertising of medicines
Advertising of medicines for human use is supervised by INFARMED, Portugal's national authority for medicines and health products.
Industry code: APIFARMA
APIFARMA, the Portuguese pharmaceutical industry association, publishes a Código Deontológico covering promotional practices and interactions with healthcare professionals, and has its own ethics council (Conselho Deontológico).
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
Pharmaceutical compliance in Portugal FAQs
What has to be declared to INFARMED?
Article 159 of the Estatuto do Medicamento covers economic advantages granted or received by entities in the medicines circuit. We help identify which interactions are in scope and set up the process and evidence behind each declaration.
Can you review promotional materials for Portugal?
Yes. We review materials and HCP interactions against Portuguese requirements, the APIFARMA code and your global standards, with local input from our Portugal-based partner.
Can Portugal be covered as part of a wider European model?
Yes. Local requirements are mapped into your global processes so Portugal is handled consistently with your other European markets.
Tell us what is on your desk.
We will listen, ask a few questions and recommend the right scope—without obligation or pressure.
Start a conversation