Pharmaceutical Advertising 2018

Pharmaceutical Advertising 2018

Saudi Arabia



1. Regulatory Framework

1.1 Laws and Self-Regulatory Codes

1.2 Application and Legal Value of Regulatory Codes

2. Scope of Advertising and General Principles

2.1 Definition of Advertising

2.2 Difference Between Information and Advertising

2.3 Restrictions on Press Releases

2.4 Comparative Advertising

3. Advertising for Unauthorised Medicines or Unauthorised Indications

3.1 Restrictions on Provision of Information on Unauthorised Medicines or Indications

3.2 Provision of Information During a Scientific Conference

3.3 Provision of Information to Healthcare Professionals

3.4 Provision of Information to Healthcare Institutions

4. Advertising to the General Public

4.1 Main Restrictions on Advertising to the General Public

4.2 Information Contained in Advertising to the General Public

4.3 Restrictions on Interactions Between Patients or Patient Organisations and Industry

4.4 Restrictions on Endorsements by Healthcare Professionals

5. Advertising to Healthcare Professionals

5.1 Restrictions on Information Contained in Advertising Directed at Healthcare Professionals

5.2 Reference to Data Not Included in the Summary of Product Characteristics

5.3 Restrictions on Reprints of Journal Articles

6. Vetting Requirements and Internal Verification Compliance

6.1 Requirements for Prior Notification/Authorisation

6.2 Compliance with Rules on Medicinal Advertising

7. Internet

7.1 Regulation of Advertising on the Internet for Medicinal Products

7.2 Advertising for Medicines on Social Media

7.3 Access Restrictions on Websites

8. Inducement/Anti-bribery General

8.1 General Anti-bribery Rules

8.2 Legislative or Self-regulatory Provisions

9. Gifts, Hospitality, Congresses and Related Payments

9.1 Gifts to Healthcare Professionals

9.2 Limitations on Providing Samples to Healthcare Professionals

9.3 Sponsorship of Scientific Meetings

9.4 Sponsorship of Cultural, Sports or Other Non-scientific Events

9.5 Grants or Donations to Healthcare Professionals or Healthcare Institutions

9.6 Restrictions on Rebates or Discounts to Healthcare Professionals or Healthcare Institutions

9.7 Payment for Services Provided by Healthcare Professionals

9.8 Prior Authorisations or Notifications

10. Transparency

10.1 Requirement to Disclose Details of Transfers of Value

10.2 Foreign Companies and Companies That Do Not Yet Have Products on the Market

11. Enforcement

11.1 Enforcement Bodies

11.2 Initiating Proceedings for Advertising Infringements

11.3 Penalties for Violating Advertising Rules and Rules on Inducements to Prescribe

11.4 Relationship Between Regulatory Authorities and Courts

11.5 Recent Enforcement Trends