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.

Which are applicable laws regarding advertising of medicines and medical devices in Bosnia and Herzegovina?

In Bosnia and Herzegovina, the primary legal framework for advertising medicines and medical devices is the Law on Medicines and Medical Devices ("Official Gazette of B&H", No. 58/08). Additionally, the Rulebook on the Manner of Advertising Medicines and Medical Devices ("Official Gazette of B&H" No. 40/2010) provides secondary regulations.

Previously, the entity Republika Srpska had its own Law on Medicines and Medical Devices ("Official Gazette of RS", No. 118/2021). However, this law was repealed by the Constitutional Court of Bosnia and Herzegovina's Decision No. U-17/22 on December 2, 2022, and it ceased to be valid the following day.

Are there self-regulatory codes of conduct?

Code of Conduct

Association of Innovative Medicine Manufacturers of Bosnia and Herzegovina (UIPL): This code, amended in 2023, regulates the advertising of prescription-only medicines to healthcare professionals and governs communication between healthcare professionals and medicine manufacturers. UIPL is part of the European Federation of Pharmaceutical Industries and Associations.

Supervisory Body

Agency for Medicines and Medical Devices of Bosnia and Herzegovina (ALMBIH): Established under the Law on Medicines and Medical Devices, ALMBIH oversees the manufacture and use of medicines and medical devices in the country.

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

Marketing Authorization

Medicines and medical devices can only be advertised if they have a marketing authorization license issued in accordance with the Law on Medicines and Medical Devices of Bosnia and Herzegovina.

Responsible Entity Obligations

Organize a service or designate a person responsible for advertising and providing information about medicines and medical devices.
Maintain copies of all advertisements, including details of the intended audience, publication method, and first publication date, available for inspection.
Ensure that individuals advertising to the professional public are properly trained.
Ensure that all advertisements comply with applicable regulations.
Implement all decisions issued by the pharmaceutical inspection promptly and fully.
Provide the pharmaceutical inspection with all necessary information to monitor advertising activities.

What is the difference in regulation between prescription-only and over-the-counter medicines?

This distinction is crucial for advertisements addressed to the general public. Advertising of non-prescription medicines to the general public is permitted under certain statutory conditions, while advertising of prescription-only medicines to the general public is generally prohibited.

This approach ensures that non-prescription medicines can be promoted for safe self-use, while prescription medicines, which require professional healthcare oversight due to potential risks and complexities, are not directly advertised to the public.

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

General Advertising Rules

Authorization Requirement

A medicine cannot be advertised unless it has an authorization license.
A medical device cannot be advertised unless it has a certificate of entry in the register of medical devices.

Prohibited Advertisements

Prescription-only medicines
Medicines issued at the expense of compulsory health insurance
Medicines containing narcotic or psychotropic substances

Restrictions on Advertising Content

Create the impression that the product has no adverse effects
Guarantee success in treatment
Imply superiority over other products
Suggest use without signs of illness
Imply health deterioration if the product is not used
Claim safety and effectiveness due to natural origin
Present the product as a food, cosmetic, or mass-use item
Suggest avoiding medical examinations or surgery
Encourage self-diagnosis or self-treatment
Suggest substitutability with other products
Target or depict children using the product
Include endorsements from professionals or public figures
Mention insurance list inclusion beyond statutory warnings
Use misleading disease histories or diagnostics
Use disturbing or deceptive images of bodily changes
Use misleading evidence of healing

Distribution and Media Restrictions

Direct distribution for promotional purposes is prohibited
Specific restrictions apply to TV, print, and other media channels

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

Do not encourage replacing products without clear medical indication
Do not make efficiency claims for products in clinical trials
Do not advertise products undergoing changes to product documentation
Ensure minimum font size of 3mm for summaries and instructions
Do not publish professional information through mass media
Do not minimize warnings or adverse reaction information
Do not undermine the therapeutic value of other products
Do not use the names of the Ministry of Health or related bodies
Do not use protected material without consent
Avoid mail formats accessible to non-professionals
Obtain prior consent for electronic communications

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

Authorization Details

Authorization number
Manner of publication
Name and address of the authorization holder

Product Information

Name and international name of active substances
Approved indications, contraindications, precautions, and adverse reactions
Dosage, method of use, and warnings
Latest approved summary of product characteristics and patient leaflet

Accuracy and Verification

All information must be accurate, current, verifiable, and sufficient for healthcare professionals to form an independent opinion on therapeutic value. Promotional materials must include the date of production or modification.

What are the advertising requirements for medicines and medical devices?

Advertisements must provide clear and accurate information, include product names and essential usage information, and remind users to read package instructions. This promotes responsible and informed use among the public.

What are the requirements for scientific data in advertisements?

Information must be truthful and scientifically proven
Compliance with summaries of characteristics and approved manuals is mandatory
Any data, tables, or graphics from scientific sources must be reproduced accurately with full source references

Rules for comparative advertising of medicinal products and medical devices

General Public

Do not claim superiority over other products
Do not suggest substitutability

Healthcare Professionals

Do not suggest substitution without medical justification
Do not undermine the therapeutic value of other products

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

Prominent warnings advising users to read the package leaflet and consult healthcare professionals must be clearly displayed
Content must not be misleading
Advertising content must be clearly identified as such

What are the enforcement mechanisms and legal consequences?

Supervisory Body

Pharmaceutical-inspectorial supervision is conducted by the pharmaceutical inspection within the Agency for Medicines and Medical Devices of Bosnia and Herzegovina.

Enforcement Measures and Penalties

Fines for legal entities range from 5,000 BAM to 15,000 BAM (approximately EUR 2,555 to EUR 7,670)
Responsible individuals may face fines from 3,000 BAM to 6,000 BAM (approximately EUR 1,535 to EUR 3,070)

What are future developments in Bosnia and Herzegovina?

An initiative to draft a new Law on Medicines and Medical Devices has been accepted by the Parliamentary Assembly
The draft law aims to align national legislation with EU regulations
The draft is currently pending review and approval
No additional developments have been reported to date

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