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 Peru

Law on Pharmaceuticals, Medical Devices, and Sanitary Products (Law N° 29459)
Regulation for the Registration, Control, and Sanitary Surveillance of Pharmaceutical Products, Medical Devices, and Sanitary Products (Legislative Decree N° 016-2011-SA)
National Policies of Medicines (Ministerial Resolution N° 1240-2004/MINSA)
Administrative Directive Regulating the Activities of Medical Visitors (Ministerial Resolution N° 413-2015/MINSA)
Technical Health Standard Establishing Ethical Criteria for Promotion and Advertising (Ministerial Resolution N° 474-2020-MINSA)
Law of Repression of Unfair Competition (Legislative Decree No. 1044)
Code of Protection and Defense of the Consumer (Law No. 29571)

2. Additional Legislative Frameworks and Ethical Standards

International and regional ethical standards applicable in Peru include:

WHO Ethical Criteria for the Promotion of Medicines
Ethical Criteria for the Promotion, Propaganda, and Advertising of Medicines by the Pan-American Network for the Harmonization of Pharmaceutical Regulations (RED PARF)
Andean Ethical Criteria for the Promotion and Publicity of Medicines by the Andean Health Agency of the Andean Community (CAN)

3. Licenses, Approvals, and Fees

3.1 General Public Advertising

Over-the-Counter Medicines and Medical Devices:

No prior approval or license is required
Advertising must comply with ethical and non-misleading guidelines

Prescription-Only Medicines and Medical Devices:

Advertising to the general public is prohibited
Promotion is limited to healthcare professionals through accredited representatives

3.2 Healthcare Professional Advertising

Pharmaceutical companies must obtain annual authorization for medical representatives from DIGEMID or the respective health facility

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

4.1 Prescription-Only Medicines

Advertising to the general public is prohibited. Marketing activities must be directed exclusively to healthcare professionals through authorized channels.

4.2 Over-the-Counter Medicines

OTC medicines may be advertised to the general public, provided regulatory guidelines are followed to ensure accuracy and prevent misleading claims.

5. Limits on Advertising to the General Public

5.1 Prescription-Only Medicines and Medical Devices

No advertising to the general public is permitted
Information must be channeled through healthcare professionals

5.2 Over-the-Counter Medicines and Medical Devices

Main precautions, warnings, and sanitary registry number must be included
Misleading or exaggerated therapeutic claims are prohibited
Advertising must be clear, factual, and promote rational use

6. Advertising to Healthcare Professionals

Medical visitors must not interfere with healthcare professionals’ activities or patient care. Information provided must be accurate, current, and consistent with the registered product dossier.

7. Information Required in Advertisements to Healthcare Professionals

Medicines

Advertisements must include information from the official data sheet submitted with the sanitary registry application. Information must be:

Legible
Visible
Truthful
Accurate
Complete
Updated

Medical Devices

Advertisements must include information from the technical report filed with the sanitary registry and meet the same requirements of legibility, visibility, accuracy, completeness, truthfulness, and currency.

Mass Written Media Requirements for Prescription Products

Product name
Active ingredient (INN)
Homeopathic designation where applicable
Pharmaceutical form
Quantity of active ingredients
Presentation
Sanitary registry number
Registry holder and importer contact details
Honest messaging that does not distort origin, benefits, characteristics, or approved uses

8. Information Required in Public Advertisements

Advertisements must include precautions, warnings, and the sanitary registry number. Therapeutic references must align with registered information and be clear and accessible.

9. Scientific Data Requirements

Scientific claims must align with sanitary registry approvals and be supported by credible, verifiable evidence. Exaggerated or unsupported claims are prohibited. Internal or unpublished studies cannot be used as sole references.

10. Comparative Advertising

Comparative advertising must be objective, relevant, and supported by verifiable scientific evidence. It must not mislead or create unfair comparisons.

11. Internet and Social Media Advertising

Advertising on internet or social media is prohibited for these products
Digital advertisements must follow the same rules as other media
Technical and regulatory information must be clearly displayed
Email advertising must not encourage self-medication or misleading claims

12. Enforcement and Legal Consequences

Monitoring Authorities

INDECOPI – Bureau of Competition and Consumer Protection
DIGEMID – Oversight of pharmaceutical and medical device compliance

Penalties

Fines ranging from approximately USD 68,000 to USD 940,000
Suspension or retraction of non-compliant advertisements
Actions initiated ex officio or based on complaints

13. Future Developments in Peru

INDECOPI digital advertising guidelines focusing on influencer transparency
Aimed at improving compliance in the evolving digital advertising landscape

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 agency