Pharmaceutical advertising regulation and medical device advertising in Portugal

For all matters not foreseen in the Legal Regime of Human Medicinal Products or the Regulation on Medical Devices and Related Accessories, the rules of the Portuguese Advertising Code (Decree-Law No. 330/90) shall apply.

In addition, Decree-Law no. 5/2017 of 6 January establishes general principles applicable to advertising of medicines and medical devices, including transparency, integrity, and restrictions on benefits granted to healthcare professionals and organisations. 

1.1 Medicines

The primary legal source is the Legal Regime of Human Medicinal Products (Decree-Law 176/2006, of 30 August). 

1.2 Medical devices 

The legal framework applicable to medical devices is currently established by Decree-Law No. 29/2024 of 5 April, which ensures the implementation in the national legal order of Regulation (EU) 2017/745. Pending the adoption of a revised national regime on advertising, the provisions governing the advertising of medical devices set out on the Regulation on Medical Devices and Related Accessories (Decree-Law 145/2009, of 17 June) remain in force on a transitional basis.

Yes, the most relevant codes of conduct are:

• The APIFARMA Code of Conduct for Promotional Practices of the Pharmaceutical Industry and  Interactions with Healthcare Professionals, Healthcare Organizations and Patient Associations, which is aligned with the EFPIA Code and widely applied in practice in relation to the promotion of medicines and, where applicable, medical devices.
• Circulars, guidelines and interpretative communications issued by INFARMED – the National Authority of Medicines and Health Products, which clarify compliance expectations in advertising and promotional practices (available at: https://www.infarmed.pt/web/infarmed/circulares). More specifically, recent INFARMED guidance has introduced good practice rules for the digital advertising of non-prescription (OTC) medicines, including promotion through social media, online platforms and other digital channels. 

3.1 Medicines 

The advertising of medicines is not subject to prior licensing or prior approval. Only non-prescription (OTC) medicines holding a valid marketing authorisation may be advertised to the general public, whereas prescription-only medicines may only be advertised to healthcare professionals through technical and scientific channels.

However, advertising materials are subject to mandatory filing with INFARMED. Marketing authorisation holders must be registered with INFARMED’s GPUB platform (Medicines Advertising Management System) and must submit each advertising piece through GPUB within 10 calendar days of its first publication. Where GPUB is temporarily unavailable, notification may exceptionally be made by email to INFARMED with a short descriptive report.

3.2 Medical devices 

Medical device advertising is not subject to prior licensing or approval and is instead subject to ex post supervision by INFARMED, which may suspend, prohibit or require the correction of unlawful advertising.

However, advertising is only permitted for devices that are lawfully placed on the market. In practice, this means the device must meet the applicable EU regulatory requirements, including completion of the relevant conformity assessment route, bear the CE marking where required, and comply with the applicable registration obligations (currently fulfilled through national procedures with INFARMED and, progressively, through EUDAMED as modules become mandatory).

As regards to the advertising directed to health professionals, holders of marketing authorisation or registration of medicines, must submit a description of all and any advertisement of medicines before the INFARMED, through the form specifically made available. Said information must be sent within 10 days after the releasing date of the advertisement campaign.

Yes.

Advertising of prescription-only medicines to the general public is strictly prohibited. As a result, any promotional activity for Rx medicines must therefore be directed exclusively at healthcare professionals and conducted through professional channels. 

By contrast, over-the-counter medicines may be advertised to the general public, provided the content is consistent with the authorised product information, is not misleading, and includes the information needed for safe use (see further the restrictions outlined in question 5).

5.1 Medicines 

Advertising of medicines to the general public is prohibited in the following cases: 

• prescription-only medicines
• medicines reimbursed by the National Health Service (“SNS”)
• medicines containing narcotic or psychotropic substances

Where advertising to the general public is permitted, it must comply with strict content restrictions. In particular, advertising must not:

• suggest that medical consultation or surgical intervention is unnecessary, including by offering a diagnosis or promoting treatment at a distance;
• claim that the effects of the medicine are guaranteed, that it is free from adverse reactions, or that it is superior or equivalent to other treatments or medicines;
• imply that a person's normal state of health can be improved by taking the medicine, or that it will be adversely affected if the medicine is not used (except in the context of approved vaccination campaigns); 
• be directed exclusively or mainly at children;
• include endorsements by healthcare professionals, scientists or public figures likely to encourage consumption;
• present the medicine as a foodstuff, cosmetic or other consumer product;
• suggest that its safety or efficacy derives from it being “natural”;
• encourage self-diagnosis through detailed descriptions of symptoms or medical history;
• use alarming, exaggerated or misleading claims of cure, or disturbing visual representations of disease or of the product’s effects

In addition, the law expressly prohibits the distribution of free samples or promotional gifts to the public and any form of comparative advertising.

5.2 Medical devices 

Advertising of medical devices to the general public is subject to similar substantive principles. In particular, advertising must not:

1. suggest that medical consultation or surgical intervention is unnecessary, including by offering a diagnosis or promoting treatment at a distance;
2. claim that the device’s effects are guaranteed, that it is free from adverse reactions, or that it is superior or equivalent to other treatments or medical devices;
3. suggest that a person’s normal state of health can be improved through the use of the device, or that it may be adversely affected if the device is not used; 
4. be directed exclusively or mainly at children;
5. include endorsements or recommendations by healthcare professionals, scientists or persons whose notoriety may encourage use of the device;
6. present the device as a foodstuff, cosmetic or other consumer product;
7. suggest that its safety or performance derives from being “natural”;
8. encourage self-diagnosis through detailed descriptions of symptoms or medical history;
9. refer in an abusive, alarming or misleading manner to demonstrations or assurances of cure; 
10. use alarming or misleading visual representations of disease or of the device’s effects on the human body

Comparative advertising of medical devices is expressly prohibited.

In addition, advertising to the general public is prohibited for medical devices that require the intervention or decision of a healthcare professional. This includes implantable devices, long-term invasive devices, devices incorporating as an integral part a medicinal product or a stable derivative of human blood or plasma, and devices manufactured utilising cells or tissues of animal origin.

Finally, advertising is only permitted for devices that have completed the applicable conformity assessment procedures and have been duly notified or registered with the competent authority (currently with INFARMED and progressively through EUDAMED).

6.1 Medicines 

Prescription-only medicines may only be advertised to healthcare professionals through technical publications or information media that are intended for, and accessible exclusively by, such professionals. 

Advertising of medicines through electronic medical prescription systems, and through any  applications or software connected to those systems, is expressly prohibited.

The supply of free samples of medicines is permitted only exceptionally and only to healthcare professionals authorized to prescribe, subject to cumulative statutory conditions, including a prior written request, quantitative limits and specific labelling and documentation requirements. In addition, samples of prescription-only medicines may only be supplied during the first two years following the start of the medicine’s effective commercialisation.

Samples of narcotic or psychotropic medicines are prohibited.

6.2 Medical devices 

Medical devices that necessarily require the intervention and decision of a healthcare professional, including implantable devices, long- term invasive devices, devices incorporating a medicinal substance or a stable derivative of human blood or plasma, and devices manufactured using animal tissues and cells, may only be advertised or promoted in technical publications or by means of information media which are intended for use and accessible only by doctors and other healthcare professionals.

The provision of free samples of certain medical devices is also strictly regulated. Such samples may only be supplied, on an exceptional basis, to healthcare professionals authorised to decide on their use, subject to specific formal requirements and traceability obligations.

7.1  Medicines 

Advertisements of medicines addressed to healthcare professionals must include a defined set of core information enabling an informed assessment of the product.

At a minimum, promotional materials must identify the medicine and include the essential information consistent with the approved Summary of Product Characteristics. This comprises, in particular, the qualitative and quantitative composition, pharmaceutical form, therapeutic indications, posology and method of administration, contraindications and adverse reactions, as well as any other clinically relevant warnings or precautions where applicable.

In addition, the advertisement must indicate the legal classification of the medicine for supply, including whether it is subject to medical prescription, and, where applicable, its reimbursement status.

Promotional documentation must be clearly dated, indicating when it was prepared or last revised. All information must be accurate, up to date, verifiable and sufficiently complete to allow healthcare professionals to form a correct view of the medicine’s therapeutic value. Any quotations or illustrative material taken from scientific or medical publications must be faithfully reproduced and properly referenced.

Finally, advertising materials must include a statement indicating that further information can be obtained from the marketing authorisation holder ("Para mais informações deverá contactar o titular da autorização de introdução no mercado") or the register holder (“Para mais informações deverá contactar o titular do registo”), as applicable. 

8.1 Medicines 

Advertising of medical devices directed to healthcare professionals must contain sufficient and reliable information to enable an informed assessment of the device’s performance and safety.

Promotional documentation must clearly indicate the date on which it was prepared or last reviewed and must provide accurate, up-to-date, verifiable and sufficiently complete information on the device’s characteristics, intended purpose and safe use.

Any quotations or illustrative material drawn from scientific or medical publications must be reproduced faithfully and the source must be clearly identified.

8.2 Medical devices

It must be clearly recognisable as advertising and must expressly identify the product as a medical device.

Such advertising must include, at a minimum:

• Name of the medical device or its trademark;
• Information essential for its safe use, including its intended purpose and any relevant precautions; and
• A clear recommendation that users read carefully the labelling and the instructions for use.  

Portuguese law does not establish a closed list of admissible categories of scientific evidence to support promotional claims. Instead, the use of scientific data in advertising is governed by general requirements of accuracy, appropriate scientific support and a clear, non-misleading presentation.

Across both medicines and medical devices, promotional statements must be capable of objective verification and must rest on scientific evidence that is adequate in light of the nature of the claim and the audience addressed. The supporting data must be conveyed in a manner that is faithful, balanced and sufficiently contextualised to enable the recipient to form a correct understanding of the product’s characteristics, performance and safety. Where reliance is placed on published studies or scientific literature, quotations and illustrative material must be reproduced accurately, and the source must be identified in a clear and traceable manner.

Promotional claims must not be framed through selective or partial presentation of results. In particular, advertising should not overstate efficacy or performance, omit clinically relevant limitations, or otherwise create an overall impression that is inaccurate or misleading.

For advertising addressed to the general public, comparative advertising is expressly prohibited for both medicines and medical devices. This prohibition covers not only direct comparisons with named competitors, but also claims that imply superiority or equivalence in relation to other medicines, devices or treatments.

By contrast, communications addressed exclusively to health professionals may include comparative claims, subject to strict conditions. Comparative advertising is permitted only where it concerns relevant and genuinely comparable characteristics, is not misleading or disparaging, and is supported by robust and verifiable evidence, such as the authorised product information (e.g., the Summary of Product Characteristics or instructions for use), credible scientific or clinical data, or other objective criteria (including price).

National law does not create a separate regime depending on the medium used for dissemination, and the above requirements are the same for any medium used. Therefore, as a general rule, conditions that apply “offline” also apply “online”.

In relation to testimonial advertising, which is particularly relevant in the context of social media, for example where digital influencers are used, the Advertising Code provides that testimonial advertising must:

• include personalised testimonials that are genuine, verifiable, and linked to the experience of the person giving the testimony (or the person they represent); and
• allow depersonalised testimonials, provided they are not attributed to a specially qualified witness, including by the use of uniforms or garments characteristic of a particular profession.

For medical devices, particularly where advertising is carried out through endorsements or recommendations, additional caution is warranted. Accordingly, the Advertising Self-Regulation Code of Conduct provides that:

• advertising must not reproduce or quote any testimony, qualified recommendation or supporting documentation that is not genuine, responsible, verifiable and relevant.
• the truthfulness of the claims made by the individual providing the testimony must be verified.
• testimonials or qualified recommendations must be linked to the experience of the person providing them.

For medicines or in vitro diagnostic medical devices, digital promotion must comply with technical-scientific and professional standards and with all applicable statutory requirements. In particular, advertising of prescription-only medicines (and certain medical devices whose use depends on healthcare professional intervention) must be strictly restricted to healthcare professionals. In the online environment, this entails implementing effective access controls and audience-restriction measures to prevent access by the general public.

In addition, INFARMED has issued specific good-practice guidance for the digital advertising of non-prescription (OTC) medicines, clarifying how statutory requirements should be implemented online, particularly on social media and in space-limited formats. In practical terms, it reinforces that digital ads should remain clear, balanced and consistent with the authorised product information, and that users should be easily directed to complete, up-to-date information. Accordingly, advertising of OTC medicines should, in particular: (i) display the mandatory statutory warning in Portuguese, advising users to read the information on the packaging and in the package leaflet carefully and, in case of doubt or persistence of symptoms, to consult a doctor or pharmacist; (ii) ensure that this statutory warning is clearly visible and prominent in the digital advertisement; and (iii) provide, within the same statement (via the word “aqui” / “here”), a direct, single-click hyperlink to the most up-to-date package leaflet of the medicinal product.

Compliance with advertising rules for medicines and medical devices in Portugal is primarily supervised by INFARMED, the national authority responsible for regulating medicinal products and medical devices. INFARMED is competent to monitor advertising practices, investigate potential infringements and initiate and decide administrative offence proceedings.

Breaches of the advertising rules for both medicines and medical devices constitute administrative offences punishable by fines ranging from approximately EUR 2,000 to EUR 3,740 for individuals and up to approximately EUR 44,890 for legal entities, depending on the nature of the infringement and the applicable regime (medicines or medical devices).  In addition to fines, INFARMED may order the publication of the essential elements of the conviction in national media at the offender’s expense and the suspension of the advertising of the relevant medicine or medical device for a period of up to two years.

Liability for infringements may attach to several parties involved in the advertising chain, including:

• the advertiser/marketing authorisation holder or device manufacturer;
• the advertising agency or other entity involved in preparing or disseminating the advertising; and
• the media owner or operator through which the advertising is made available.

At present, no major reform of the advertising regime for medicines is expected in the short term, and the current framework remains largely stable.

However, the situation is different for medical devices, where the legal framework is currently in transition. The Portuguese legislator has already indicated that a new legislative act specifically governing the advertising of medical devices will be adopted. Until that act is enacted, the existing advertising rules set out in Decree-Law No. 145/2009 remain applicable (in particular the provisions on advertising contained in Chapter XIII and the relevant sanctioning provisions).