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Muscat – In an effort to bolster public health safeguards, Oman’s Ministry of Health—through its Drug Safety Centre—has unveiled a comprehensive new regulatory framework outlining stringent rules for pharmaceutical advertising and licensure
Pharmaceutical companies, their local agents, and accredited pharmaceutical consulting firms are the only parties authorized to promote medicines.
Scientific offices may also advertise, but only after obtaining explicit approval from the Drug Safety Centre
Unqualified individuals are strictly prohibited from promoting pharmaceutical products under the new rules
All advertising content must receive prior written authorization from the Drug Safety Centre.
Ad materials must align precisely with the medicine’s internal leaflet and the Summary of Product Characteristics (SmPC), targeting only specified audiences
Materials that are false, misleading, exaggerated, or denigrating to other medicines are strictly forbidden.
Advertising must also adhere to Oman’s standards of public order and morality
Licence applications must include the medicine’s registration certificate, proof of payment, and the exact content to be advertised omanobserver.om.
The Drug Safety Centre commits to deciding on applications within 60 days—and failure to respond within that timeframe is treated as a rejection
If any documents are missing, the applicant has 30 days to provide them; failure to comply results in automatic cancellation of the application, after which a new submission can only be made 30 days later
Advertisements are licensed for a term of three months, renewable under the same conditions.
Renewal applications must be submitted at least 20 days before the current licence expires
Delays or lapses in requests or documentation may lead to refusal or cancellation .
The Drug Safety Centre reserves the right to suspend any licence if a drug is found to pose health risks or emerge as ineffective
Applicants refused a licence can appeal to the Minister of Health within 60 days; a decision must be made within 30 days, or the appeal is considered rejected .
Oman's updated regulations are designed to elevate the integrity and transparency of pharmaceutical marketing. By restricting advertising to qualified entities, enforcing alignment with approved medical summaries, and tightening deadlines and appeal processes, the Ministry aims to curb misleading promotions and protect public welfare.
Source : Oman issues new guidelines for drug advertising and licensing - Oman Observer
