Pharmaceutical advertising regulation and medical device advertising in Colombia

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.

• 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.

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

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.

• Must be truthful and not deceitful.

• 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.

8.1 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.

• 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.

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

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.

Not that we are aware of.