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 Regarding Advertising of Medicines and Medical Devices in North Macedonia

Primary Legislation

Law on Medicines and Medical Devices: The foundational legal framework governing the advertising of medicines and medical devices in North Macedonia. This law has been amended several times since its enactment on September 13, 2007, and provides detailed stipulations on how these products can be advertised.
Guidebook on the Manner of Advertising on Medicines and Medical Devices: A bylaw issued in 2008 that complements the primary legislation by outlining specific procedures and restrictions for advertising medical products.

2. Additional Legislative Frameworks and Self-Regulatory Codes of Conduct

There are no additional bylaws or self-regulatory codes of conduct specifically for the advertising of medical products in North Macedonia beyond the primary legislation and the Guidebook on Advertising.

3. Licenses, Approvals, and Fees

3.1 General Public

Market authorization holders and producers may advertise over-the-counter medical products to the general public only with prior approval from the Agency on Medicines and Medical Devices.
The Agency applies the following fees for approval:
- EUR 200 for one pharmaceutical form, strength, and package size
- EUR 200 for each additional pharmaceutical form in the same advertisement
- EUR 100 for each additional strength of the same form in the same advertisement
- EUR 100 for each additional package size or type of the same form and strength
- EUR 200 for assessing any form of advertising to the general public

3.2 Healthcare Professionals

No special approval is required for advertising to healthcare professionals. Market authorization holders may advertise through professional magazines and by directly informing healthcare professionals who prescribe the products.

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

Prescription-Only Medicines (POM)

Advertising of prescription-only medicines to the general public is prohibited.
These products may only be advertised to healthcare professionals involved in prescribing, dispensing, or administering them.

Over-the-Counter Medicines

May be advertised to the general public with prior approval from the Agency.
Advertising is subject to restrictions and requirements outlined in the Guidebook on Advertising.

5. Restrictions on Advertising to the General Public

The following elements are prohibited when advertising to the general public:

Financial inducements suggesting coverage by the Health Insurance Fund, except in specific public health emergencies.
Mentioning the price of the medical product.
Using celebrity endorsements.
Misleading claims that could result in misdiagnosis or inappropriate use.
Sensitive content that could disturb or mislead consumers about diseases or treatments.
Use of unapproved clinical trial data.
Targeting children or depicting children using the advertised product.

6. Advertising to Healthcare Professionals

The Law on Medicines distinguishes between three forms of advertising to healthcare professionals:

Promotion
Providing free samples
Sponsoring expert gatherings

The same restrictions apply to medicines and medical devices. The most comprehensive rules apply to promotional activities, which prohibit:

Encouraging prescription, issuance, or purchase through money, gifts, or other benefits.
Encouraging replacement of one medical product with another without medical justification.
Drawing conclusions about products undergoing clinical trials.
Promoting products during changes to the SmPC or user guidelines.
Using SmPCs or user guides printed in unreadable formats.
Publishing promotional information through media advertising health facilities or stores.
Downplaying precautions or adverse reactions.
Undermining the therapeutic value of competing products.
Using employees of the Ministry of Health or the Agency in advertising.
Using protected intellectual property without permission.
Using postcards or messages visible to the general public.
Using electronic communication without explicit prior consent.

7. Information Required in Advertisements to Healthcare Professionals

Comprehensive product characteristics and therapeutic effects.
Date of marketing approval or last change.
Clear indication of whether the product is OTC or prescription-only.
Optional inclusion of the product’s retail price.

8. Advertising Requirements

The following information must be included in advertisements aimed at the general public:

Product name
Instructions for correct use
Clear safety warning encouraging reading of the user guide and consulting a doctor or pharmacist about risks and adverse reactions

9. Scientific Data Requirements

Advertisements must be based on true and scientifically validated data. For medicines, compliance with the Summary of Product Characteristics (SmPC) and approved user guides is mandatory. Data must reflect current and approved product information.

10. Comparative Advertising

Comparative advertising of medical products is strictly prohibited under North Macedonian law. Advertisements must not compare products or diminish the value of competing medical products.

11. Internet and Social Media Advertising

For internet advertisements, mandatory safety warnings must be clearly displayed on the starting page of the advertisement. This applies to all digital platforms.

12. Enforcement Mechanisms and Legal Consequences

Compliance Monitoring

Conducted by the Agency through pharmaceutical inspectors.
Pharmaceutical wholesalers with turnover above MKD 10,000,000 are subject to enhanced inspections.

Penalties

Inspectors may prohibit unlawful advertising and order destruction of materials.
EUR 50,000 fine for legal entities for serious violations including advertising to the general public or children.
EUR 15,000 fine for responsible persons within legal entities.
EUR 5,000 to EUR 7,500 fine for responsible employees.
EUR 30,000 fine for violations related to advertising to healthcare professionals.
EUR 9,000 fine for responsible persons.
EUR 3,000 to EUR 4,500 fine for responsible employees.

13. Future Developments in North Macedonia

There are currently no publicly announced changes or developments in the regulatory framework for advertising medical products in North Macedonia.

How Can OMC Help?

Professional review of marketing and advertising materials with detailed reports
Assistance in obtaining authority approvals where required
Professional translation of marketing materials as an ISO 17100 certified translation agency