Out-Licensing (GCC)
Out-licensing in the UAE involves granting the rights to another company to manufacture, market, and distribute a pharmaceutical product within the country. The process involves the identification of potential licensees, negotiation of a licensing agreement, regulatory approval, manufacturing and quality control, marketing and distribution, and pharmacovigilance and regulatory compliance. Out-licensing in the UAE allows pharmaceutical companies to tap into local market expertise, distribution networks, and regulatory knowledge while expanding their product portfolio and reaching a wider patient population. Regular communication and collaboration between licensor and licensee are essential to maintain product quality and monitor market performance. Consult legal and regulatory experts and local business partners to ensure a successful licensing process.
Identification of Potential Licensees:
The pharmaceutical company seeking to out-license its product identifies potential local partners in the UAE who have the necessary infrastructure, market knowledge, and distribution capabilities.
Negotiation of Licensing Agreement:
The licensor and licensee negotiate the terms of the licensing agreement, which include rights and obligations, financial terms, territory, exclusivity, regulatory compliance, and intellectual property considerations.
Regulatory Approval:
The licensee obtains the required regulatory approvals from the UAE Ministry of Health and other relevant authorities to manufacture and market the licensed product in compliance with local regulations.
Manufacturing and Quality Control:
The licensee establishes manufacturing facilities or partners with a contract manufacturing organization (CMO) to produce the licensed product. Strict quality control measures are implemented to ensure compliance with regulatory standards.
Marketing and Distribution:
The licensee develops marketing strategies and promotes the product to healthcare professionals, hospitals, clinics, and pharmacies in the UAE. PDC distribution and logistics to ensure the availability of the product across the country.
Pharmacovigilance and Regulatory Compliance:
The licensee monitors the safety and efficacy of the licensed product and complies with local pharmacovigilance requirements. They also maintain compliance with any regulatory updates or changes during the product’s lifecycle.