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

Medicines

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

Medical Devices

• Decree 4725/2005

2. What are self-regulatory codes of conduct?

There exists a self-regulatory code for medicament advertisement issued by the R&D pharmaceutical products guild (Afridro).

However, this code is not enforceable and serves only as a self-regulating list of best practices.

3. What are the Licenses, Approvals, and Fees for advertising medicines and medical devices?

In Colombia, over-the-counter (OTC) medicines and low-risk medical devices may be approved for advertisement to the general public by the National Medicines Market Approval Authority, INVIMA. This approval process must be completed before the advertisement can be used.

Prescription medicines and high-risk medical devices are not allowed to be advertised to the general public. However, medical information material addressed to healthcare professionals is permitted and does not require INVIMA approval.

4. What is the difference in regulation between prescription-only and over-the-counter medicines?

Prescription-only medicines cannot be advertised to the general public, whereas over-the-counter (OTC) medicines may be advertised.

5. What are the restrictions on advertising medicines and medical devices to the general public?

Medicines

• Advertisements cannot contravene general rules applicable to education, health, nutrition, or therapeutic matters.
• Advertisements cannot be untrue or deceitful.
• Advertisements cannot make pejorative comparisons with other brands, products, or companies.
• For prescription products, promotions, raffles, or similar activities are not allowed.

Medical Devices

• Medical devices must have been previously approved by INVIMA.
• Advertisements must be truthful and not deceitful.

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

Advertising to healthcare professionals must be truthful and not deceitful.

7. What information is required in advertisements directed only at healthcare professionals for medicines and medical devices?

Medicines

Mandatory Information:

• Indications and therapeutic uses
• Contraindications
• Side effects
• Administration risks
• Drug dependence risks
• Precautions and warnings

Medical Devices

All information must comply with available technical evidence.

There are no specific mandatory phrases; however, the information must be accurate and based on technical evidence.

8. What are the advertising requirements for medicines and medical devices?

Advertisements to the General Public – Medicines

• “It is a medicine.”
• “Do not exceed your consumption.”
• Market approval number.
• “Read indications and contraindications.”
• “If symptoms persist, consult a doctor.”

Advertisements to the General Public – Medical Devices

There are no mandatory phrases or specific wording requirements for medical devices.

9. What are the requirements for scientific data in advertisements for medicinal and medical device products?

• All scientific data must be true, accurate, and properly sourced.
• Any limits on the application or validity period of the data must be clearly indicated.
• No claims about cure rates or effectiveness are allowed without scientific proof.
• No unsubstantiated “research findings” or “data proofs” are permitted.

10. Are there any rules governing comparative advertising of drugs and medical devices?

Comparative advertising is allowed, provided it follows the general advertising rules applicable in Colombia.

11. How to advertise medicines and medical devices on the internet and social media?

The same rules applicable to traditional media advertising also apply to internet and social media postings.

12. What are the enforcement mechanisms and legal consequences?

Enforcement Authority

INVIMA (National Food and Drug Surveillance Institute).

Penalties for Non-Compliance

• Fines, which are the primary penalty for non-compliant advertisements.
• Cancellation of market approval in extreme cases.

13. Are there any future developments in Colombia?

There are no known future developments in Colombia regarding these regulations.

How can OMC help?

• OMC offers professional review of marketing and advertising materials and provides reports.
• Services to obtain authority approvals where required.
• Translation of marketing materials by a professional translation agency certified with ISO 17100.