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 Serbia?

1.1 Medicines

“Official Gazette of RS”, No. 30/2010, 107/2012, 113/2017, and 105/2017
“Official Gazette of RS”, No. 79/2010 and 102/2018

1.2 Medical Devices

“Official Gazette of RS”, No. 105/2017
“Official Gazette of RS”, No. 102/2018

2. Are there self-regulatory codes of conduct?

Serbian Association of Innovative Medicine Manufacturers (INOVIA): This association has a Code of Conduct that governs the advertising of prescription-only medicines and outlines the standards for interactions between pharmaceutical companies and healthcare professionals. This code complements the statutory requirements and promotes ethical advertising practices within the industry.

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

Marketing Authorization (MA): Both medicines and medical devices must generally have a marketing authorization before they can be advertised. This authorization ensures that the product has been evaluated for safety, efficacy, and quality.

Pre-approval of Advertising Material: The Agency for Medicines and Medical Devices must approve all advertising materials before they can be used. This includes reviewing the content to ensure compliance with legal requirements and preventing misleading or inappropriate advertisements.

Notification to the Ministry of Health: Once the Agency approves an advertisement, it must notify the Ministry of Health within 15 days (about 2 weeks). The Ministry of Health can also request advertising materials and may impose additional restrictions on advertising specific medicines or medical devices.

4. What is the difference in regulation: prescription-only vs. over-the-counter medicines?

Prescription-Only Medicines: It is prohibited to advertise prescription-only medicines directly to the general public. These advertisements can only target healthcare professionals, ensuring that the promotion of such medicines is appropriately managed by those qualified to prescribe them.

Over-the-Counter Medicines: These can be advertised to the general public, but the advertisements must comply with specific regulations to avoid misleading claims and ensure that the public receives accurate information about the products.

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

5.1 Medicines

Prohibited Advertisements

Advertising that is misleading, suggests self-healing, or portrays the medicine in a sensational manner is prohibited. Claims that medicine is food, cosmetics, or other general use items are also banned.

Specific Bans

Prescription-only medicines
Medicines reimbursed by health insurance funds
Medicines containing intoxicating or psychoactive substances
Medicines for serious conditions such as tuberculosis, sexually transmitted diseases, infectious diseases, chronic insomnia, diabetes, and other metabolic diseases

Children and Samples

Medicines cannot be advertised directly to children or offered as free samples to the public.

5.2 Medical Devices

Misleading Claims

Advertisements must clearly state that the product is a medical device and must not imply that it is harmless, guarantees treatment success, or can be used without consulting a physician.

Restrictions on Imagery and Claims

No distressing images
No implication of self-diagnosis or self-treatment
No suggestion that not using the device will harm health
No unsubstantiated effectiveness claims

Specific Prohibitions

Showing children using medical devices without adult supervision
Advertisements primarily aimed at children
Naming specific pharmacies or practices where the device can be purchased
Claims about devices undergoing clinical trials

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

6.1 Medicines

Prohibition of gifts, rewards, or benefits to influence prescriptions
No diminishing of safety warnings or other medicines’ therapeutic value
No unreadable small print or unauthorized intellectual property
No implication of endorsement by the Ministry of Health or regulators
Direct marketing via phone, fax, or email requires explicit prior consent

6.2 Medical Devices

No rewards or benefits to influence prescription or recommendation
No undermining the value of other devices
No unauthorized intellectual property
Direct marketing requires prior written consent
No encouragement to replace devices without clear medical indication

7. What information is required in advertisements directed only at healthcare professionals?

7.1 Medicines

Information aligned with the Summary of Product Characteristics (SmPC)
Accurate, up-to-date, verifiable, and complete data
Issuance regime (prescription-only or OTC)
Date of last revision
Labeling: “for healthcare professionals only”
Free samples allowed for new medicines marked “Free sample, not for sale”

7.2 Medical Devices

Name, intended use, and key features
Accurate, complete, and up-to-date information
Date of registration
Properly referenced scientific literature
Labeling: “for healthcare professionals only”
Use of the term “safe” only with proper explanation
Free samples marked “Free sample, not for sale”

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

8.1 Medicines

Clear identification that the product is a medicine
Essential usage information
Mandatory warning:
“Prior to use, study the instructions in detail! For indications, precautions, and adverse reactions, consult with a physician or pharmacist.”
Electronic media must display the warning separately with a voice message

8.2 Medical Devices

Clear identification as a medical device
Correct usage information
Mandatory warning:
“Before use, read the instructions carefully and consult a physician or pharmacist regarding possible risks and adverse reactions.”
No naming of specific retail outlets
No clinical trial claims to the general public

9. What are the requirements for scientific data in advertisements?

Information must be truthful and scientifically valid
Support rational and ethical use
Proper justification for safety-related claims
Accurate referencing of up-to-date scientific literature

10. Are there any rules governing comparative advertising?

General Public: Comparative advertising is restricted and must not imply superiority or replacement without justification.

Healthcare Professionals: Comparative advertising must not promote interchangeability without medical indication or undermine other authorized products.

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

While no specific laws apply exclusively to online advertising, all general advertising rules apply equally.

Internet advertisements must include essential information within the main message and not merely via links.

12. What are the enforcement mechanisms and legal consequences?

Regulatory Bodies

Agency for Medicines and Medical Devices
Ministry of Health

Penalties

Medicines: Legal entities fined RSD 800,000–2,000,000; individuals RSD 80,000–150,000
Medical Devices: Legal entities fined RSD 1,500,000–3,000,000; individuals RSD 100,000–200,000

13. What are future developments in Serbia?

As of now, there have been no announced changes or developments in the regulations governing the advertising of medicines and medical devices in Serbia.

How can OMC help?

Professional review of marketing and advertising materials with reports
Services to obtain authority approvals where required
Translation of marketing materials by an ISO 17100 certified professional translation agency