Oman Issues New Regulations on Medicine Advertising and Promotion

Muscat: In a move to strengthen public health protections and ensure the ethical promotion of pharmaceutical products, Oman’s Ministry of Health has issued a new set of regulations governing the advertisement and promotion of medicines.

The decision, issued by Dr. Hilal bin Ali Al Sabti, Minister of Health, is grounded in the provisions of the Pharmacy Practice Law (Royal Decree No. 35/2015), its executive regulations (Ministerial Resolution No. 113/2020), and Ministerial Resolution No. 71/2024 on service fees.

Under the new regulations, only licensed pharmaceutical companies, local agents, or authorised pharmaceutical consulting offices may advertise or promote medicinal products — and only with prior approval from the Drug Safety Center.

Key Licensing Conditions

According to Article 3 of the resolution, to obtain a license for medicine advertisement, the following conditions must be met:

• The medicine must be officially registered in Oman.
• Advertisement content must be consistent with the approved drug leaflet and the summary of product characteristics (SmPC).
• The advertisement must clearly define the target audience.
• Content must not violate public morals, disrupt public order, or pose any risk to public health.
• No misleading, exaggerated, or comparative statements are allowed.
• The advertisement must comply with any additional guidelines set by the Center.

Application Process

Applicants must submit the following to the Drug Safety Center:

• A copy of the proposed advertisement or description.
• The drug registration certificate.
• Proof of payment of prescribed fees.
• Any additional documents requested by the Center.

The Center will review applications and respond within 60 days. If no response is issued within this period, the application is considered rejected. In cases of missing information, applicants will be notified and given up to 30 days to complete the application; otherwise, it will be deemed cancelled.

License Validity and Renewal

Licenses are valid for three months, with the option to renew for additional three-month periods. Renewal requests must be submitted at least 20 days before expiry and are subject to the same conditions as the original license.

Advertising Guidelines

Once licensed, the advertiser must:

• Clearly display the license number in all promotional materials.
• Ensure advertisements strictly adhere to the approved format.
• Refrain from modifying advertisements without prior approval.
• Target advertisements primarily to pharmacists.
• Restrict promotion of prescription medications to scientific journals, conferences, or direct engagement with qualified healthcare professionals.

Appeals and License Suspension

Applicants whose requests are rejected may file a grievance with the Minister within 60 days. A decision will be made within 30 days.

The Drug Safety Center retains the right to suspend any license if new evidence emerges regarding the medicine’s risk or ineffectiveness.