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 Hungary

Act XCVIII of 2006 (“Medicines Thrift Act”)
Decree no. 3/2009 (II. 25.) of the Minister of Health (“Promotional Decree”)
Act XLVIII of 2008 (“Advertisement Act”)
Act XLVII of 2008 (“Unfair Commercial Practices Act”)
Act CLV of 1997 (“Consumer Protection Act”)
Act LVII of 1996 (“Competition Act”)

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

Medicines

Code of Ethics for Pharmaceutical Communication: Issued by the Association of the Innovative Pharmaceutical Manufacturers and other associations, updated as of 1 June 2022.
Code of Conduct: Provided by the Association of Innovative Pharmaceutical Manufacturers.
Summary and Position of the National Institute of Pharmacy and Nutrition: Covers promotional activities discussed during the Public Consultation on Promotion Supervision held on September 12, 2019. This is a non-binding document reflecting the authority’s interpretation of the laws.
Summary on Amendments to the Medicines Thrift Act: Issued by the National Institute of Pharmacy and Nutrition, effective from 29 June 2021. It addresses rules on the promotion of medicinal products, infant formulae, and medical aids. This is a non-binding document with the authority's interpretation of the laws.

Medical Devices

ETOSZ Code of Conduct: Provided by the Association of Health Technology Suppliers and Medical Device Manufacturers.
Code of Advertising Ethics: Issued by the Hungarian Advertising Self-Regulatory Board and other associations, effective as of 30 June 2023.
MedTech Europe Code of Ethical Business Practice: Provided by MedTech Europe.

3. Licenses, Approvals, and Fees

3.1 General Public

No specific licensing required
Conformity Statement: Advertisers must provide a statement to the advertising service provider that the product has been inspected or certified and found suitable for marketing. Without this statement, advertising cannot be published.

3.2 Healthcare Professionals (HCPs)

Medicines and Medical Devices Qualifying as Medical Aids

Notification and Fees: Promoters must notify the National Centre for Public Health and Pharmacy (NNGYK) and pay an administrative service fee of HUF 101,500 (approximately EUR 262).
Registration of Sales Representatives: Medical sales representatives must be registered with NNGYK, with a fee of HUF 100,000 (approximately EUR 258) per representative and an additional certificate fee of HUF 12,900 (approximately EUR 33).
Monthly Fees: HUF 832,000 (approximately EUR 2,150) per month for each medical sales representative and HUF 83,000 (approximately EUR 214) per month for sales representatives promoting medical aids. Reduced amounts may apply for SMEs.

Medical Devices Not Qualifying as Medical Aids

N/A: There are no specific rules or fees for advertising these devices to healthcare professionals.

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

Prescription-Only Medicines (POMs): POMs cannot be advertised to the general public under any circumstances.

Over-the-Counter Medicines (OTCs): OTC medicines can be advertised to the general public, provided advertisements comply with legal and ethical guidelines and do not encourage inappropriate use.

5. Restrictions on Advertising to the General Public

5.1 Medicines and Medical Devices Qualifying as Medical Aids

General Rules

All information in commercial communication must conform to the Summary of Product Characteristics (SmPC), package leaflet, or instructions for use.

Specific Legal Prohibitions

Conducting commercial practices without a valid Marketing Authorization.
Promoting subsidized products to the general public.
Advertising to children, including in child-oriented programs or publications.

Advertisement Restrictions

Products not authorized for marketing or use in Hungary
Products containing narcotics or psychotropic substances
Investigational medicinal products
OTC products sharing a name with a POM
Medical aids sharing a name with subsidized medical aids

Advertisement Content Restrictions

Implying medical consultations or surgery are unnecessary
Guaranteeing recovery or lack of side effects
Presenting products as food or cosmetics
Claiming efficacy due to natural origin
Encouraging self-diagnosis or fear-based messaging
Using endorsements from professionals, scientists, or celebrities
Suggesting health damage if the product is not used

Prohibited Practices

Offering gifts, samples, vouchers, or prizes to patients or consumers directly or indirectly to promote specific medicinal products or subsidized medical aids is prohibited.

Code of Ethics for Pharmaceutical Communication

Commercial practices must appear as neutral information
Advertising nature must be clearly identifiable
Materials must not resemble independent scientific publications
Claims must be scientifically proven and well-founded

5.2 Medical Devices Not Qualifying as Medical Aids

Aggressive, misleading, and unlawful comparative advertising is prohibited
Advertisements must not endanger personal safety or child development
Advertising devices for performing abortions is strictly prohibited

6. Advertising to Healthcare Professionals

6.1 Medicines and Medical Devices Qualifying as Medical Aids

Promotional information must conform to the SmPC and package leaflet
Promotion without valid marketing authorization is prohibited
Information must enable healthcare professionals to form a well-founded opinion

6.2 Medical Devices Not Qualifying as Medical Aids

The same general rules apply as for advertising to the general public.

7. Information Required in Advertisements Directed to Healthcare Professionals

7.1 Medicines and Medical Devices Qualifying as Medical Aids

Price and reimbursement details for subsidized products
Accurate, verifiable, and up-to-date information with date of last update
Accurate citations from medical journals
Black triangle and monitoring note for products under additional monitoring

7.2 Medical Devices Not Qualifying as Medical Aids

Promotional materials must provide detailed and verifiable information enabling healthcare professionals to form an informed opinion.

8. Advertising Requirements

8.1 Medicines and Medical Devices Qualifying as Medical Aids

Clear identification as medicinal product or medical aid
Product name and encouragement of proper use
Warnings about risks and side effects

8.2 Medical Devices Not Qualifying as Medical Aids

General advertising rules apply, emphasizing truthful and evidence-based claims.

9. Scientific Data Requirements

9.1 Medicines and Medical Devices Qualifying as Medical Aids

Sources must be clearly specified and accurately reproduced
Scientific data must be well-founded and proven

9.2 Medical Devices Not Qualifying as Medical Aids

Scientific data must be presented accurately with truthful representation of research results.

10. Comparative Advertising

Comparisons must be objective, relevant, and verifiable
Misleading or unsubstantiated comparisons are prohibited

11. Internet and Social Media Advertising

General advertising regulations apply
Content for healthcare professionals must not be publicly accessible
Social media policies should prevent inappropriate sharing

12. Enforcement and Legal Consequences

Hungarian Competition Authority and Consumer Protection Authorities monitor compliance
Fines and corrective actions apply for non-compliance
NNGYK oversees promotion and may impose fines or bans
Ethical procedures may be initiated under applicable codes