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MoH tightens rules on promotion, marketing of drugs

1 Jun 2025 MoH tightens rules on promotion, marketing of drugs in Oman By MOHAMMED TAHA

Muscat – Ministry of Health (MoH) has announced new regulations for advertising and promoting medicines aimed at safeguarding public health and ensuring ethical marketing practices in the pharmaceutical sector.

Issued by H E Dr Hilal bin Ali al Sabti, Minister of Health, Ministerial Decision No 135/2025 outlines procedures and conditions that pharmaceutical firms, agents and consultants must follow before promoting any medicinal product in Oman. The decision was issued on May 29 and will come into effect from today.

Under the new rules, only licensed pharmaceutical companies, authorised local agents and approved pharmaceutical consulting offices can advertise medicines. All advertising must be pre-approved by the Drug Safety Centre.

To be eligible for a licence, the product must be registered, and the advertising content must match the approved drug leaflet and summary of product characteristics. It must clearly define the target audience and avoid any wording that could mislead consumers, exaggerate benefits, harm public health or breach public morals.

“The objective is to protect consumers from misleading information and to ensure that advertisements remain factual and within the ethical boundaries of public health,” a ministry official said.

Applicants must submit a copy of the advertisement, the drug’s registration certificate, proof of fee payment and any other documents requested by the centre.

The Drug Safety Centre is mandated to respond within 60 days. No response within that timeframe implies rejection.

If an application is found incomplete, the applicant will be given 30 days to address shortcomings. Failure to do so within that period will result in application cancellation.

Licences are valid for three months and may be renewed for similar periods. Renewal requests must be submitted at least 20 days before licence expiry and will be assessed under the same terms.

Advertisers must include the licence number in all materials and documentation, use only approved formats and obtain prior approval for any change.

Advertising prescription-only medicines is restricted to scientific publications or at conferences and professional meetings attended by pharmacists and healthcare workers.

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