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 for Promoting Medicines and Medical Devices in Norway

1.1 Medicines

The Medicines Act (Lov om legemidler m.v.), Act No. 132 of 4 December 1992
The Medicines Regulation (Forskrift om legemidler til mennesker), Regulation No. 1839 of 18 December 2009
The Marketing Act (Markedsføringsloven), Act No. 2 of 9 January 2009

1.2 Medical Devices

The Medical Devices Act (Lov om medisinsk utstyr), Act No. 37 of 7 May 2020
The Medical Devices Regulation (Forskrift om medisinsk utstyr), Regulation No. 1476 of 9 May 2021
EU Regulations (MDR and IVDR):
- Medical Devices Regulation (EU) 2017/745 (MDR) and In Vitro Diagnostic Medical Devices Regulation (EU) 2017/746 (IVDR) are incorporated into Norwegian law.
- These regulations ensure high levels of safety and health protection while promoting innovation.
The Marketing Act (Markedsføringsloven): Ensures advertisements for medical devices are fair, accurate, and not misleading.

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

2.1 Medicines

Association of the Pharmaceutical Industry in Norway (LMI) Guidelines

Designed for LMI members but widely followed across the industry
Aligned with IFPMA and EFPIA Codes of Practice
Cover interactions with healthcare professionals and public communication

Consumer Authority Guidelines

Address marketing of cosmetic procedures, including online and social media advertising
Ensure advertising is not misleading and complies with marketing laws

2.2 Medical Devices

There are no specific self-regulatory codes for medical devices beyond general laws and EU regulations. Manufacturers must comply with MDR and IVDR principles, ensuring accurate and non-misleading advertising.

3. Licenses, Approvals, and Fees

3.1 Medicines

A marketing authorization from the Norwegian Medical Products Agency (NMPA) is required before advertising.
Authorization confirms quality, safety, and efficacy through documented risk-benefit analysis.

3.2 Medical Devices

Medical devices must bear a CE mark before being marketed in Norway
Higher-risk devices require conformity assessment by a notified body prior to CE marking

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

Prescription Medicines

Advertising to the general public is strictly prohibited
Ensures medicines are used under professional supervision

Over-the-Counter (OTC) Medicines

Advertising is permitted
Advertisements must be clear, balanced, and must not encourage inappropriate use

5. Restrictions on Advertising to the General Public

5.1 Medicines

Prescription medicines cannot be advertised to the public, except for vaccination campaigns
OTC medicine advertisements must not mislead and must encourage responsible use
Serious illnesses must not be referenced in advertising
Advertisements must be clearly identifiable as promotional content

5.2 Medical Devices

Advertising must be accurate, objective, and precise
Misleading claims or suggestions of unapproved uses are prohibited
Claims must be supported by documented evidence

6. Restrictions on Advertising to Healthcare Professionals

6.1 Medicines

Only medicines with valid marketing authorization may be advertised
Advertisements must promote rational use with unbiased information
Promotional materials must include detailed SmPC information and scientific references
Offering gifts or economic benefits to healthcare professionals is prohibited
Distribution of free samples is regulated and restricted

6.2 Medical Devices

The same advertising rules apply to healthcare professionals and the general public
All claims must be accurate and evidence-based

7. Information Required in Advertisements to Healthcare Professionals

7.1 Medicines

Approved Summary of Product Characteristics (SmPC)
Dispensing regulations
Pricing and reimbursement information
Date of creation or last revision of the material
Reminder advertisements may include only the product name, active substance, and marketer

7.2 Medical Devices

Compliance with MDR and IVDR Article 7
Claims must reflect approved intended use and performance
Advertisements must not create false impressions

8. Information Required in Public Advertisements

8.1 Medicines (OTC)

Clear and factual information
Product name and active ingredients
Usage instructions
Recommendation to read packaging and patient leaflet

8.2 Medical Devices

Clear description of intended purpose
Disclosure of potential risks and side effects
No misleading claims or unapproved uses

9. Scientific Data Supporting Promotional Claims

Medicines

Claims must be supported by SmPC or peer-reviewed scientific publications
Internal company research reports are not valid references
Observational or non-interventional data must be clearly identified as such

Medical Devices

Claims must be substantiated with documented scientific evidence
Information must accurately reflect device performance and characteristics

10. Comparative Advertising

Comparative advertising is allowed if not misleading
Only relevant and comparable attributes may be compared
Both advertiser and competitor products must be presented objectively

11. Internet and Social Media Advertising

Same rules apply across all platforms including websites and social media
Clear distinction must exist between public and healthcare professional content
Prescription-only medicines may only appear on HCP-designated pages

12. Enforcement and Legal Consequences

Monitoring Authorities

Norwegian Medical Products Agency (NMPA)
Norwegian Consumer Authority

Penalties

Fines, sanctions, or other penalties depending on severity
Competitors may report violations, but only authorities may initiate enforcement

13. Future Developments in Norway

No significant changes or developments are currently anticipated in Norway’s regulations governing advertising of medicines and medical devices.

How Can OMC Help?

Professional review of marketing and advertising materials with detailed reports
Support in obtaining authority approvals where required
Professional translation of marketing materials as an ISO 17100 certified translation agency