Portugal: Pharmaceutical Advertising

This country-specific Q&A provides an overview to Pharmaceutical Advertising laws and regulations that may occur in Portugal.

  1. What laws are used to regulate advertising on medicines in your jurisdiction?

  2. Are press releases regarding medicines allowed in your jurisdictions, and if so what are the restrictions on these (bearing in mind the target audience)?

  3. Are there any processes prescribed (whether by law or Codes of Practice) relating to the approval of advertising of medicines within companies?

  4. Do companies have to have material approved by regulatory bodies prior to release?

  5. Is comparative advertising for medicines allowed and if so, what restrictions apply?

  6. Please provide an overview of the rules that apply to advertising to the general public for prescription only medicines and over the counter medicines, an indication of the information that must or must not be included.

  7. Are there any restrictions on interactions between patients or patient organisations and industry (e.g., consultation, sponsorship)? If so, please describe those briefly.

  8. Which information must advertising directed at healthcare professionals contain, and which information is prohibited? For example can information about clinical trials, or copies of journal be sent?

  9. May pharmaceutical companies offer gifts to healthcare professionals and are there any monetary limits?

  10. Are pharmaceutical companies allowed to provide samples to healthcare professionals?

  11. Is sponsorship of scientific meetings or congresses and/or attendance by healthcare professionals to these events? If so, which restrictions apply? Do additional restrictions apply to events taking place abroad?

  12. What are the restrictions on the organisation of cultural, sports or other non-scientific events in relation to scientific conferences by pharmaceutical companies?

  13. Is it possible to pay for services provided by healthcare professionals and if so, which restrictions apply?

  14. Are pharmaceutical companies permitted to provide grants or donations to healthcare professionals or healthcare institutions? Does it matter if the grant or donation is monetary or in kind?

  15. Are pharmaceutical companies required to disclose details of transfers of value to healthcare professionals or healthcare institutions? If so, please indicate whether this is a legal requirement or not, and describe briefly what the companies must report and how. Do these transparency requirements apply to foreign companies and/or companies that do not yet have products on the market?

  16. When if at all with a competent authority have to get involved in authorising advertising? Is advertising on the internet (including social media) for medicinal products regulated, and if so, how? Should companies include access restrictions on websites containing advertising or other information intended for healthcare professionals?

  17. Are there any anti-bribery rules apply to communications between pharmaceutical companies and healthcare professionals or healthcare organizations?

  18. What are the rules (whether statutory or self-regulatory) which govern the offering of benefits or inducements to healthcare professionals?

  19. Which bodies are responsible for enforcing the rules on advertising and the rules on inducement? Please include regulatory authorities, self-regulatory authorities and courts.

  20. On what basis and before which bodies or courts can companies initiate proceedings against competitors for advertising infringements?

  21. What are the penalties, sanctions or measures that regulators or courts can impose for violating medicines advertising rules and rules on inducements to prescribe in your jurisdiction?

  22. What is the relationship between procedures before or measures taken by the self-regulatory authority and the procedures before or measures taken by courts/government competent authorities?

  23. Are there any recent enforcement trends in relation to pharmaceutical advertising in your jurisdiction? Please report any significant (publicly known) enforcement actions in the past two years.