Muscat – The decision, issued by Dr. Hilal bin Ali Al Sabti, Minister of Health, is aimed at enhancing public health safeguards and ensuring ethical, accurate representation of pharmaceutical products.
The regulation is based on the Law Regulating the Practice of the Pharmacy Profession and Pharmaceutical Institutions (Royal Decree No. 35/2015) and its executive regulations (Ministerial Resolution No. 113/2020), as well as Ministerial Resolution No. 71/2024 concerning service fees.

According to the resolution, no entity other than licensed pharmaceutical companies, local agents, or authorised pharmaceutical consulting offices may advertise or promote medicines unless they obtain prior approval from the Drug Safety Center.

Article 3 of the resolution stipulates following conditions to obtain a license:
• The medicine must be registered.
• The content of the drug advertisement or description must not conflict with the drug leaflet and the summary of drug characteristics (SmPC).
• The advertisement or description of the drug should specify the target groups.
• The advertisement or description of the medicine must not violate public order or public morals, and must not include anything that would harm public health.
• The advertisement or description of the medicine must not contain any misleading information, or any phrase that harms other medicines, or indicates exaggeration or exaggeration.
• Any other requirements specified by the advertising or drug identification guide approved by the centre.
The application for a license shall be submitted to the Centre along with the following documents and data:
• A copy of the drug advertisement or description.
• Drug registration certificate.
• What is the benefit of paying the prescribed fee?
• Any other documents or data requested by the Center.

The Centre shall study the license application and decide on it within a period not exceeding sixty days from the date of its submission, fulfilling all the required conditions, documents and data. The expiry of this period without a response shall be considered a rejection of the application.
In the event that the license application does not meet the required conditions, documents and data, the applicant shall be notified of the deficiencies in his application and shall be given a period not exceeding 30 days from the date of notification to complete the deficiencies, otherwise the application shall be deemed cancelled.

Licenses are valid for three months, renewable for similar periods. Renewal requests must be submitted at least 20 days before the license expires and are subject to the same conditions as the original license.
When advertising or promoting the drug, the licensee must:

• Include the drug’s license number in all advertisements.
• Ensure the advertisement strictly adheres to the format approved by the Center.
• Refrain from making any changes to the advertisement without prior approval from the Centre.
• Limit advertising and publicizing of medicines primarily to pharmacists.
• Specifically for prescription drugs, advertising or introduction must be confined to scientific magazines, conferences, or direct meetings with pharmacists, their assistants, or medical and allied health professionals.

Applicants whose licenses are rejected can file a grievance with the Minister within 60 days of notification, with a decision expected within 30 days. The Center also reserves the right to suspend a license if new developments indicate risks or ineffectiveness of the drug.