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 Laws Apply When It Comes to Promoting Medicines and Medical Devices?

Law no. 148/2000 on Advertising
Audiovisual Law no. 504/2002
Law no. 95/2006 on Healthcare Reform
Ministry of Health Order no. 194/2015
National Audiovisual Council Decision no. 220/2011
Government Emergency Ordinance no. 46/2021

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

Romanian Association of International Medicines Manufacturers (ARPIM): This association, a member of the European Federation of Pharmaceutical Industries and Associations (EFPIA), has a code of conduct that its members must adhere to, specifically regarding the promotion of medicines.

Romanian Association of the Self-Care Industry (RASCI): This association focuses on the self-care industry, including over-the-counter products, and has guidelines for the advertising practices of its members.

Association of Suppliers of Medical Products (AFPM): As a member of MedTech Europe, AFPM provides a code of conduct for its members involved in the supply and advertising of medical devices.

3. Licenses, Approvals, and Fees

3.1 Medicines

Over-the-Counter (OTC) Medicines:

Advertising materials for OTC medicines targeted at the general public must be approved by the National Agency for Medicines and Medical Devices in Romania (ANMDMR). The marketing authorisation holder is responsible for obtaining this approval.

The approval process involves a fee of RON 550 for OTC medicines and RON 350 for educational materials.

Prescription-Only Medicines (POMs):

Advertising of POMs to the general public is prohibited. These medicines may only be advertised in materials intended for healthcare professionals. These materials do not require prior approval but may be reviewed by ANMDMR after publication.

3.2 Medical Devices

General Public:

Advertising of medical devices to the general public requires prior approval from ANMDMR, especially for devices with a high health risk. Advertising should encourage rational use and provide clear, non-misleading information.

Healthcare Professionals:

Advertising intended solely for healthcare professionals does not require prior approval unless it concerns high-risk devices. In such cases, an emergency notification to ANMDMR is necessary.

4. Difference Between Prescription and Over-the-Counter Medicines

Romanian law governs the advertisement of prescription-only and over-the-counter medicines differently.

POMs: Cannot be advertised to the general public. Advertising is restricted to professional healthcare channels and must comply with specific guidelines.
OTCs: Can be advertised to the general public, provided the advertising materials receive prior approval from ANMDMR and comply with general advertising standards.

5. Primary Limits on Promoting Drugs and Medical Devices to the Public

5.1 Medicines

Without Authorization

If the medicine does not have a valid marketing authorisation in Romania
If the medicine is advertised without ANMDMR approval where required

Specific Medicines

Prescription-only medicines (POMs)
Medicines containing narcotic or psychotropic substances (except approved vaccination campaigns)
Medicines prescribed and released under the health insurance system

Content Restrictions

Suggesting avoidance of medical consultation or surgery
Guaranteeing the medicine’s effect or claiming it has no adverse reactions
Implying health will worsen without the medicine or improve only with it
Targeting primarily or exclusively at children
Emphasizing recommendations from celebrities or healthcare professionals
Misrepresenting medicine as a food, cosmetic, or consumer product
Claiming safety or efficacy because it is a “natural” substance
Encouraging incorrect self-diagnosis or misleading assurances of healing
Using alarming or deceptive imagery of illnesses or the medicine’s effects
False claims regarding marketing authorisation
Using diminutives or emotionally manipulative language
Incorporating content from non-medicine campaigns (cosmetics, food supplements, etc.)

5.2 Medical Devices

Objective Presentation

Encouraging rational use without exaggeration
Providing accurate, current, and verifiable information
Supporting claims with clinical evidence aligned with user instructions

Prohibited Advertisements

Devices requiring prescription or medical recommendation
Devices not intended for use without professional intervention unless pharmacist advice suffices

Content Restrictions

Suggesting avoidance of medical consultation or surgery
Guaranteeing device effectiveness or absence of adverse reactions
Comparing devices as superior to other treatments
Implying health deterioration without device use
Targeting primarily or exclusively at children
Featuring endorsements from celebrities or healthcare professionals
Misrepresenting the device as a cosmetic or consumer product
Claiming safety or efficacy due to being “natural”
Encouraging incorrect self-diagnosis
Using alarming or deceptive imagery

Radio and Television Restrictions

Advertising prescription-only devices
Featuring healthcare professionals or associations recommending devices
Broadcasting during or adjacent to children’s television programs

6. Limits on Promoting Drugs and Medical Devices to Healthcare Professionals

6.1 Medicines

Advertising through electronic medical prescription applications or linked software is prohibited
Free samples are allowed only under strict conditions and in limited quantities

6.2 Medical Devices

High-risk devices may only be advertised through professional channels
Promotional materials must include the date of the last review and accurate scientific references

7. Required Information for Advertisements to Healthcare Professionals

7.1 Medicines

Name of the medicine and active ingredient (INN)
Pharmaceutical form and formulation
Dosage details for each route and indication
First marketing authorisation or renewal date
Essential information from the SmPC
Date of last SmPC revision
Statement: “This promotional material is intended for health professionals”
Dispensing method and prescription category
SmPC information must use a minimum font size of 10

7.2 Medical Devices

Clear statement that content is intended exclusively for healthcare professionals
Name of the device and manufacturer or representative
Intended use, characteristics, and performance
Device classification
Essential usage information

8. Information Required in Public Advertisements

8.1 Medicines

Clear statement that the product is a medicine
Therapeutic indications and precautions
Recommendation to read packaging and leaflet and consult healthcare professionals

8.2 Medical Devices

Clear statement that the product is a medical device
Name, purpose, and special precautions for safe use
Recommendation to read instructions and consult professionals if necessary

9. Constraints on Data Supporting Promotional Claims

Information must be accurate and scientifically validated
Claims must align with approved product summaries
Claims must be supported by robust clinical data
Misleading or selective data presentation is prohibited

10. Comparative Advertising Rules

Comparative advertising to the general public is prohibited
Comparisons are permitted only if objective, relevant, non-misleading, and supported by credible clinical data

11. Internet and Social Media Advertising

Scope

Includes webpages, emails, forums, blogs, and other electronic supports, excluding social networks and mobile applications.

Approval

All internet advertisements must be evaluated and approved by ANMDMR.

Mandatory Website Information

Sponsor identity and physical and electronic address
Complete references for all medical information
Target audience identification
Advertising visa number and issuance date
Investor, media, and public information
Health education content and therapeutic alternatives
Latest approved SmPC and package leaflets
Links to EMA or national public assessment reports
Recommendation to consult a healthcare professional

Prohibitions

Advertising medicines via email, SMS, or social networks

POM Advertising to Healthcare Professionals

Restricted access through password-protected systems
Inclusion of complete SmPC information
Compliance with national and international regulations

Medical Devices

Local industry associations may impose additional specific requirements.

12. Oversight Bodies and Legal Consequences

Monitoring Authorities

ANMDMR
National Consumer Protection Agency
Ministry of Finance
Romanian Audiovisual Council

Penalties

Fines from RON 10,000 to RON 30,000
Fines up to RON 20,000 per breach
Suspension or withdrawal of authorisations
Market withdrawal of products

13. Future Developments in Romania

Currently, no specific future developments in the regulation of medicine and medical device advertising in Romania have been announced.

How Can OMC Help?

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