Pharmaceutical advertising regulation and medical device advertising in Colombia

  1. 1. Which laws are applicable regarding advertising of medicines and medical devices?
  2. 2. Are there any other legal regimes such as self-regulatory codes of conduct that govern the advertising of medicines and medical devices?
  3. 3. What kind of licenses/approvals/fees (if any) are required for medicines and medical devices to be advertised to the general public and healthcare professionals?
  4. 4. Does the law in Colombia regulate the advertising of prescription-only and over-the-counter medicines differently?
  5. 5. What are the main restrictions applicable to the advertising of medicines and medical devices to the general public?
  6. 6. What are the main restrictions applicable to the advertising of medicines and medical devices to healthcare professionals?
  7. 7. What information must appear in advertisements directed only to healthcare professionals for medicines and medical devices?
  8. 8. What information must appear in advertisements directed to the general public for medicines and medical devices?
  9. 9. Please summarise the requirements for scientific data indicated in advertisements. Are there any restrictions on the data on which the promotional claims are based (data on file, retrospective analyses, such as subgroup analyses or meta-analyses etc.)?
  10. 10. Are there specific rules for comparative advertisement of medicines and medical devices?
  11. 11. Are there specific provisions for advertisement of medicines and medical devices on the internet/in social media postings?
  12. 12. Please describe the enforcement mechanism. Which bodies monitor compliance with the advertisement provisions and what are the legal consequences (e.g. penalties) for non-compliance?
  13. 13. Any future developments in Colombia?

1. Which laws are applicable regarding advertising of medicines and medical devices?

1.1 Medicines

  • Decree 677/1995
    • Resolution 4536/1996
    • Resolution 4320/2004

1.2 Medical devices

  • Decree 4725/2005

It exists indeed a self-regulatory code for medicaments advertisement, issued by the R&D pharma products Guild (called Afridro).

However, this is not really enforceable, it is merely a self-regulating list of best practices.

3. What kind of licenses/approvals/fees (if any) are required for medicines and medical devices to be advertised to the general public and healthcare professionals?

  • OTC medicines may obtain approval before the National Medicines Market Approval Authority called INVIMA for advertisement pieces for the general public. This procedure needs to be conducted prior to the advertisement pieces being used.
  • The same applies for low risk medical devices.
  • Prescription medicines and high risk medical devices cannot be advertised to the general public. Medical information material addressed to healthcare professional is allowed and does not need to the approved by INVIMA.

4. Does the law in Colombia regulate the advertising of prescription-only and over-the-counter medicines differently?

Yes. Prescription-only cannot be advertised to the general public, but OTC may indeed.

5. What are the main restrictions applicable to the advertising of medicines and medical devices to the general public?

5.1 Medicines

  • Cannot contravene general rules applicable to education, health, nutrition or therapeutic.
  • Cannot be untrue or deceitful.
  • Cannot make pejorative comparison for other brands, products, or companies.
  • For prescription products, promotions, raffles or the like are not allowed.

5.2 Medical devices

  • Must have been previously approved by INVIMA. Must be truthful and not deceitful.

6. What are the main restrictions applicable to the advertising of medicines and medical devices to healthcare professionals?

  • Must be truthful and not deceitful.

7. What information must appear in advertisements directed only to healthcare professionals for medicines and medical devices?

  • In the materials addressed to the health professionals, indications and therapeutic uses must be specified without omitting contraindications, side effects, administration and drug dependence risks, precautions and warnings known by the manufacturers.
  • No specific requirements for medical devices but all information must comply with the technical evidence available.

8. What information must appear in advertisements directed to the general public for medicines and medical devices?

8.1 Medicines

The following phrases must be included in the advertisement: It is a medicine; Do not exceed your consumption; market approval number; Read indications and contraindications; If symptoms persist, consult a doctor. “

8.2 Medical devices

No specific phrases or wording are required.

9. Please summarise the requirements for scientific data indicated in advertisements. Are there any restrictions on the data on which the promotional claims are based (data on file, retrospective analyses, such as subgroup analyses or meta-analyses etc.)?

  • There are no specific requirements as per the scientific data to be included in advertisements.
  • Generally, no advertisement pieces addressed to the general public include in-depth scientific information.
  • Pieces addressed to healthcare professionals include in-depth scientific data, but there are no specific requirements, as long such information may be considered truthful and not deceitful.

10. Are there specific rules for comparative advertisement of medicines and medical devices?

No. General rules for comparative advertisement (it is allowed in the country) applies.

11. Are there specific provisions for advertisement of medicines and medical devices on the internet/in social media postings?

No. General rules for advertisement, notwithstanding the media in which it is promoted, apply to Internet postings.

INVIMA monitors the market, and in case non-compliant, non-approved advertisement is detected, an administrative probe will be started. The main penalty as a consequence of this probe is normally a fine. However, in extreme cases the penalty may be the cancellation of the market approval for the product.

13. Any future developments in Colombia?

Not that we are aware of.

Portrait of Karl Mutter, LL.M.
Karl Mutter, LL.M.
Partner
Bogotá
Portrait of Luz Helena Vargas
Luz Helena Vargas
Associate Director
Bogotá