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 Croatia?

1.1 Medicines

Medicines Act (Croatian: “Zakon o lijekovima”)
Bylaw on Advertising of Medicines (Croatian: “Pravilnik o načinu oglašavanja o lijekovima”)
Act on Preventing Conflicts of Interest (Croatian: “Zakon o sprječavanju sukoba interesa”)

1.2 Medical Devices

Medical Devices Act (Croatian: “Zakon o medicinskim proizvodima”)
Act on the Implementation of Regulation (EU) 2017/745 on Medical Products and Regulation (EU) 2017/746 on in Vitro Diagnostic Medical Devices (Croatian: “Zakon o provedbi Uredbe (EU) 2017/745 o medicinskim proizvodima i Uredbe (EU) 2017/746 o in vitro dijagnostičkim medicinskim proizvodima”)
Act on Preventing Conflicts of Interest (Croatian: “Zakon o sprječavanju sukoba interesa”)

2. Are there any self-regulatory codes of conduct?

2.1 Medicines

Governed by the Croatian Association of Innovative Pharmaceutical Initiative (iF!), this code sets ethical standards for advertising medicines.

2.2 Medical Devices

Established in 2017, it is the Croatian association of MedTech Europe, but it has not yet established a specific code of conduct for advertising medical devices.

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

3.1 Medicines

No specific license or approval is required exclusively for advertising. However, statutory limitations on what can be advertised must be followed.

Advertising includes any form of information intended to encourage prescribing, issuance, sale, and consumption in written, oral, pictorial, audio, electronic, or digital formats.

Medicines can only be advertised to healthcare professionals and in professional literature or at scientific conferences. General public advertising is forbidden except for public health activities related to immunization, seroprophylaxis, and chemoprophylaxis.

Medicines can be advertised to both the general public and healthcare professionals where permitted by law.

Advertising a medicine without marketing authorization in Croatia is allowed only at professional conferences and in professional literature if the marketing authorization process has been initiated and only the common name is used. Claims of curative properties are forbidden unless approved for marketing as a medicine or registered as a traditional herbal medicine.

3.2 Medical Devices

Advertising is allowed if the medical device meets the legal requirements of the Medical Devices Act.

Devices intended for exhibitions, fairs, or similar events must display a visible sign stating that they are not intended for market placement or use.

Medical devices can only be advertised to healthcare professionals.

Misleading claims about medical devices are expressly forbidden.

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

Prescription-Only Medicines

Advertising is prohibited, except for specific public health activities. Advertising is allowed in professional literature, at conferences, and when directed to healthcare professionals.

Over-the-Counter Medicines

Advertising must contain the information specified in the relevant regulations.

Mandatory declaration: “Read the package leaflet carefully before use and ask your doctor or pharmacist for the risks and side effects” (Croatian: “Prije upotrebe pažljivo pročitajte uputu o lijeku, a o rizicima i nuspojavama upitajte svog liječnika ili ljekarnika”).

Advertising must not be misleading and must be clearly identified as an advertisement.

The text “Paid medicine advertisement” (Croatian: “Plaćeni oglas o lijeku”) must be clearly visible with a font size equal to or larger than the rest of the advertisement content.

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

5.1 Medicines

Only medicines with marketing authorization in Croatia may be advertised.
Medicines undergoing authorization may be advertised at professional or scientific meetings using only the common name.
Advertisements must not exaggerate effects, guarantee success, or contradict product labeling, instructions for use (IFU), or the Summary of Product Characteristics (SmPC).
Print and online articles must clearly display “Paid medicine advertisement” (Croatian: “Plaćeni oglas o lijeku”).

Content Restrictions

No claims of no side effects, non-toxicity, or absence of addiction risk.
No claims that health will improve with use or deteriorate without use.
Advertisements must not target or be primarily addressed to children.
No endorsements by scientists, healthcare professionals, or high-profile individuals.
Medicines must not be promoted as natural products to imply safety or effectiveness.

5.2 Medical Devices

Only devices compliant with the Medical Devices Act may be advertised, except for exhibition devices clearly labeled as not for market use.
Advertisements must not contain misleading information.
Advertisements must not include information prohibited by medical device regulations.

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

6.1 Medicines

Claims must be evidence-based and not exaggerated.
The term “safe” must be explained; the term “new” is restricted to medicines marketed for less than one year.
No premiums or financial/material benefits may be provided, except items of insignificant value (below HRK 70.00 excluding VAT) relevant to professional practice.
Free samples may only be provided upon written request, in the smallest available packaging, labeled “Free medical sample – not for resale.”
Specific rules apply depending on whether healthcare professionals are employed in public or private health institutions.

6.2 Medical Devices

No gifts, rewards, or privileges are allowed except items under HRK 70.00 (excluding VAT) related to professional practice.
Gifts must not be provided in response to healthcare professional requests.
Different rules apply for healthcare professionals working in public versus private institutions.

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

7.1 Medicines

Information based on the SmPC and approved package leaflet.
Indication of prescription-only or over-the-counter status.
Personal and authorization holder details.
Trade name and international name of the active substance.
Approved uses and contraindications.
Side effects, precautions, and warnings.
Dosage instructions and method of use.
Last approved SmPC and package leaflet.
Mandatory statement “Only for HCPs” (Croatian: “Samo za zdravstvene radnike”) and the date of last update.

7.2 Medical Devices

The Medical Devices Act specifies prohibited information rather than mandatory content.

Devices used solely for healthcare activities may be advertised exclusively to healthcare professionals.

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

8.1 Medicines

Brand name and scientific name of the active substance.
Essential information for proper use.
Clear warning that the medicine may cause adverse effects and advice to follow instructions or consult a healthcare professional.
In audiovisual media, warnings must be provided in audio form.

8.2 Medical Devices

Claims must not be directed primarily or exclusively at children.
Claims must not encourage abandoning accepted therapeutic procedures.
Claims must not endanger human dignity.
Devices must not be promoted as natural products to imply safety or effectiveness.

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

9.1 Medicines

Advertisements must not include statements from scientists or healthcare professionals using their reputation to promote a medicine.
Scientific citations must be accurately reproduced from medical journals or scientific publications.

9.2 Medical Devices

Avoid using scientific terms not commonly understood by the general public.
Advertisements must not use statements from scientists or healthcare professionals to leverage professional reputation.

10. Rules for comparative advertising of medicinal products and medical devices

Comparative advertisements must not claim superior effectiveness or safety compared to other medicines or medical devices.

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

Advertising medicines on the internet must comply with the Bylaw on Advertising of Medicines.

Websites must separate content for the general public and healthcare professionals.
Sections intended for healthcare professionals must be password-protected.
Advertisements must include the mandatory warning about reading the package leaflet and consulting a healthcare professional.
The warning must be part of the advertisement itself and clearly readable.
The text “Paid medicine advertisement” must be clearly visible with appropriate font size.

12. What are the enforcement mechanisms and legal consequences?

Regulatory Body

The Pharmaceutical Inspection of the Ministry of Health oversees compliance.

Powers

The inspection authority may request information, conduct on-site inspections, and issue binding orders and corrective measures.

Penalties

Medicines: Fines ranging from approximately EUR 13,333 to EUR 20,000 for non-compliant advertisements.
Medical Devices: Fines ranging from approximately EUR 13,333 to EUR 93,000 for misleading advertisements.
Competition law risks may arise from payments or advantages granted to healthcare professionals or laboratories that could influence patient flow or earnings.

13. Are there any future developments in Croatia?

Currently, no new developments are envisaged regarding the advertisement regulations for medicines and medical devices in Croatia.

How can OMC help?

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