Advertising Regulations for Medicines and Medical Devices in Portugal

1. Overview

Advertising of medicines and medical devices in Portugal is regulated by the Legal Regime of Human Medicinal Products (Decree-Law 176/2006 of 30 August) for medicines and the Regulation on Medical Devices and Related Accessories (Decree-Law 145/2009 of 17 June) for medical devices. General advertising rules from the Portuguese Advertising Code apply where specific laws do not cover. These ensure true, scientifically proven, and ethical information to promote rational use without misleading. Self-regulatory codes like Apifarma's Code of Conduct supplement the framework. INFARMED issues clarifying circulars. Source: https://cms.law/en/int/expert-guides/cms-expert-guide-to-advertising-of-medicines-and-medical-devices/portugal

2. General Rules and Approvals

No licenses or fees are needed for advertising, but marketing authorization holders notify INFARMED within 10 days of release using specific forms, including ad descriptions and dissemination details. For medical devices, similar notifications for HCP promotions. Ex post control allows complaints. Advertising must be ethical and verifiable. Source: https://cms.law/en/int/expert-guides/cms-expert-guide-to-advertising-of-medicines-and-medical-devices/portugal

3. Advertising to HCPs vs. the Public

To the General Public

Prohibited for prescription-only medicines, narcotics, psychotropics, and subsidized medicines. Ads must not suggest unnecessary consultations, guarantee effects without side effects, imply improved health from use or impaired without (except vaccinations), target children, use celebrities, treat as food/cosmetics, claim natural safety, induce self-diagnosis, misuse cure guarantees, or use abusive visuals. No free samples or offers. Comparative ads prohibited. For medical devices, bans on ads for professional-intervention devices unless conformity-assessed; ads identify as device, include name, safe use info, and advise reading instructions. Source: https://cms.law/en/int/expert-guides/cms-expert-guide-to-advertising-of-medicines-and-medical-devices/portugal

To Healthcare Professionals

Allowed for restricted products in technical publications or HCP media. Prohibited in prescription apps. Free medicine samples at HCP request, limited quantities, for prescribers/dispensers. For devices requiring mediation, limited to HCP media. Materials include review date, accurate performance/safety info, sourced quotes. Mandatory info: For medicines, name, composition, indications, dose, contraindications, effects, classification, reimbursement; for devices, similar accuracy requirements. Source: https://cms.law/en/int/expert-guides/cms-expert-guide-to-advertising-of-medicines-and-medical-devices/portugal

4. Online Advertising

Same rules as offline; testimonials must be genuine and verifiable; depersonalized allowed without qualified attributions. For devices, no non-genuine endorsements. Medicines restrict prescription content access to HCPs via barriers. Social media influencers comply with authenticity. Source: https://cms.law/en/int/expert-guides/cms-expert-guide-to-advertising-of-medicines-and-medical-devices/portugal

5. Samples and Inducements

Medicine samples restricted to HCP requests, specific products, limited quantities. No public samples or offers. Source: https://cms.law/en/int/expert-guides/cms-expert-guide-to-advertising-of-medicines-and-medical-devices/portugal

6. Meetings and Sponsorships

Regulated by Apifarma Code for HCP interactions. Source: https://cms.law/en/int/expert-guides/cms-expert-guide-to-advertising-of-medicines-and-medical-devices/portugal

7. Specific Requirements and Restrictions

Comparative ads: Prohibited for public; for HCPs, must be relevant, non-misleading, based on credible data. Enforcement: INFARMED initiates proceedings; fines €2,000 to 15% turnover (up to €180,000), possible conviction publication, ad suspension up to 2 years. Additional sanctions: forfeiture, bans, authorization suspensions. Definitions: Medicines are human products; devices require assessment/notification for public ads. Last updated: 08 May 2024. Source: https://cms.law/en/int/expert-guides/cms-expert-guide-to-advertising-of-medicines-and-medical-devices/portugal