Kuwait Enforces New Regulations on Pharmaceutical Promotions

Kuwait City, Kuwait Aug 27, 2026 ALN: Minister of Health Dr. Ahmed Al-Awadhi issued Ministerial Decree No. 296/2026, establishing new regulations for promoting medicines and medical products, as well as guidelines for interactions with company representatives in ministry facilities.

The decree mandates that all promotional information must be accurate, clear, up-to-date, and verifiable, based on reliable scientific references or the approved product leaflet. It emphasizes that benefits, risks, and warnings must be presented in a balanced manner. The promotion of off-label uses is strictly prohibited, along with the use of phrases such as ‘best’, ‘safest’, and ‘most powerful’ without published and reliable scientific evidence.

All promotional materials—whether printed, electronic, or distributed through various channels—are subject to review and approval. Safety materials, uses, side effects, and warnings must receive clearance from the Kuwait Pharmacovigilance Center (KPCV).

The decree stipulates that companies must not operate as medical representatives without obtaining a permit from the Pharmaceutical Inspection and Licensing Department. This permit is personal, non-transferable, and valid for one year, with the option for annual renewal. The application process requires online submission, including company authorization, representative credentials, commercial license, academic qualifications, a photograph, and a civil identification card.

Companies are also required to notify the ministry of any changes regarding the representative’s information or termination of their relationship. Representatives are prohibited from entering hospitals and healthcare facilities without prior appointment and approval. Upon entry, they must present their identification card and permit.

Access to clinics, emergency rooms, wards, patient rooms, operating theaters, and other sensitive areas is restricted. Representatives are not allowed to communicate with patients or their families, access patient files, or enter procurement areas without official approval for non-promotional purposes.

The decree emphasizes the prohibition of direct promotional communication between companies and members of committees responsible for drug evaluation and procurement. Communication must occur exclusively through the committee rapporteur or the designated official entity. Representatives may only attend committee meetings through official invitation for technical clarifications, without participating in deliberations or voting. Committee members are required to disclose any conflicts of interest.

The ministry reserves the right to request comprehensive technical files from companies, which include clinical evidence, safety data, and proposed restrictions. The decree prohibits the provision of gifts, cash payments, or any personal benefits to healthcare providers or committee members, linking sponsorship or support to the prescription or purchase of medical products.

Institutional support for scientific and training activities is permitted under ministry regulations, provided transparency is maintained. Sponsored lectures and seminars must present balanced content, clearly displaying the sponsoring company’s name and role.

Company representatives are forbidden from distributing pharmaceutical samples or medical products free of charge within ministry facilities. Samples must be submitted through official channels, and no samples will be accepted without verification of registration and compliance with storage requirements.

The decree specifies that the remaining shelf life of samples must be at least six months and clearly marked ‘Free Sample’. It prohibits using samples to influence prescribing patterns or violate procurement regulations.

Upon confirmation of a violation, the ministry may issue warnings or withdraw promotional materials. Companies are obligated to issue corrections for misleading information, and representatives may face suspension or bans from ministry facilities.

Promotional activities may be suspended, and violations referred to regulatory authorities. The decree categorizes violations as minor, moderate, or serious, with serious violations including promoting products outside approved uses or providing misleading information.

Official forms for implementing these provisions will include registration of company representatives, commitment pledges, and reporting of violations. Companies are granted a three-month grace period to comply, with the decree taking effect immediately upon publication in the official gazette, ‘Kuwait Al-Youm’.