Importance of Regulations for Advertising Medicines and Medical Devices

Healthcare regulations safeguard public health by ensuring accurate information and ethical marketing. They prevent misleading claims, promote responsible advertising, and require scientific evidence for product claims. This empowers patients with reliable information and protects them from misuse of medications. Regulations also ensure fair competition within the industry.

1. Applicable Laws for Advertising Medicines and Medical Devices in Portugal

Portuguese Advertising Code: Applies to all advertising matters not covered by specific legislation for medicines and medical devices.
Legal Regime of Human Medicinal Products (Decree-Law 176/2006 of 30 August): Primary legal framework regulating advertising of medicines.
Regulation on Medical Devices and Related Accessories (Decree-Law 145/2009 of 17 June): Governs medical devices and aligns with the Advertising Code.

2. Additional Legislative Frameworks and Self-Regulatory Codes

Apifarma Code: Regulates promotional practices in the pharmaceutical industry and interactions with healthcare professionals and institutions.
INFARMED Circulars and Informative Communications: Provide detailed rules and guidance on advertising practices and are available on the INFARMED website.

3. Licenses, Approvals, and Fees

Medicines

Marketing authorization holders must submit a description of the advertisement to INFARMED within 10 days after release.
Alternatively, a copy of the advertising material may be submitted within the same timeframe.

Medical Devices

Advertisements directed at healthcare professionals are subject to similar submission requirements to INFARMED.

4. Prescription-Only vs. Over-the-Counter Medicines

Prescription-only Medicines: Advertising is prohibited except through technical or scientific publications accessible only to healthcare professionals.
Advertising must not be directed at the general public.

5. Limits on Advertising to the General Public

5.1 Medicines

Advertising of medicines to the general public must not:

Suggest that medical consultation or surgery is unnecessary
Promote diagnosis or treatment by correspondence
Imply guaranteed effects or superiority over other treatments
Claim absence of side effects or adverse reactions
Suggest enhancement of normal health
Imply deterioration of health if the medicine is not used, except in vaccination campaigns
Be directed primarily or exclusively at children
Include recommendations from celebrities or healthcare professionals that encourage use
Present the medicine as a food, cosmetic, or consumer product
Claim safety or efficacy due to being “natural”
Include detailed descriptions that could lead to incorrect self-diagnosis
Misleadingly depict diseases, injuries, or the medicine’s effect on the body

5.2 Medical Devices

Advertising medical devices to the general public must not:

Discourage Medical Consultation

Suggest avoiding medical consultation or surgery
Promote diagnosis or treatment by correspondence

Guarantee Efficacy or Safety

Claim guaranteed effects or superior results
Imply absence of side effects or adverse reactions

Promise Improved Health

Suggest improved normal health through device use
Imply worsened health if the device is not used

Target Children

Be directed primarily or exclusively at children

Use Endorsements

Include recommendations from celebrities or healthcare professionals encouraging use

Misrepresent the Product

Present the device as food, cosmetic, or consumer product
Claim safety or efficacy due to being “natural”

Encourage Self-Diagnosis

Provide depictions leading to incorrect self-diagnosis

Use Frightening or Misleading Imagery

Misleadingly depict bodily impact or disease effects
Engage in comparative advertising

6. Limits on Advertising to Healthcare Professionals

Medicines

Electronic medical prescription applications must not include advertisements
Free samples are limited and provided only upon request to authorized persons

Medical Devices

Advertisements may only appear in technical publications for healthcare professionals
Documentation must be accurate, updated, complete, and correctly reproduce scientific quotations

7. Required Information in Advertisements to Healthcare Professionals

Medicines

Name and qualitative and quantitative composition
Pharmaceutical form and therapeutic indications
Dosage, contraindications, and adverse effects
Dispensing classification and reimbursement system

Medical Devices

Date of last review
Accurate and complete performance and safety information
Correctly reproduced scientific quotations

8. Information Required in Public Advertisements

Medicines

Statement that the product is a medicine
Name and essential usage information
Therapeutic indications and special precautions
Advice to read instructions and consult healthcare professionals if needed

Medical Devices

Statement that the product is a medical device
Name and essential usage information
Special precautions
Advice to read instructions carefully

9. Scientific Data Requirements

Advertisements must present true and scientifically proven information aligned with ethical criteria and the summary of product characteristics.

10. Comparative Advertising

General Public: Comparative advertising is prohibited.
Healthcare Professionals: Permitted if relevant, comparable, non-misleading, and based on credible clinical data or product summaries.

11. Internet and Social Media Advertising

No additional online-specific requirements exist. The same rules apply offline and online.

Testimonials

Must be genuine, verifiable, and based on personal experience
Must not imply qualifications not genuinely held

Medical Devices

Endorsements must be genuine, responsible, and relevant
Truthfulness of testimonial claims must be verified

Medicines and In Vitro Diagnostic Devices

Online advertising must follow technical-scientific principles
Access restrictions must ensure prescription-only products target healthcare professionals

12. Enforcement and Legal Consequences

Monitoring Authority

INFARMED oversees compliance with advertising regulations

Penalties

Fines from EUR 2,000 up to 15% of annual turnover or a maximum of EUR 180,000
Publication of convictions in national media at the offender’s expense
Suspension of advertising for up to two years

Liability

Liability may extend to advertisers, advertising agencies, media holders, or concessionaires.

Accessory Sanctions

Forfeiture of illicit objects
Prohibition of business activities for up to two years
Loss of right to participate in public tenders for up to two years
Suspension of licenses or rights for up to two years

13. Future Developments in Portugal

There are currently no known upcoming changes in the regulation of advertising medicines or medical devices in Portugal.

How Can OMC Help?

Professional review of marketing and advertising materials with reports
Support in obtaining authority approvals where required
Professional translation of marketing materials as an ISO 17100 certified translation agency