MoHAP transfers several pharma-related services to Emirates Drug Establishment

The UAE is making several changes to the regulatory frameworks governing the pharmaceutical sector, with the Ministry of Health and Prevention (MoHAP) transferring many of its services to the Emirates Drug Establishment (EDE).

The organisational change will help realign regulatory and supervisory roles within the healthcare sector. It will ensure clarity regarding the authority responsible for each service, particularly in areas related to the regulation of medicines, medical supplies, and associated health products.

MoHAP added that the transfer of these services to the EDE does not represent a change in its commitments to customers, but is a redistribution of responsibilities in accordance with governing legislation. This approach not only enhances the flexibility of the healthcare system and improves the customer journey by reducing points of contact, but also accelerates decision-making cycles, and unifies regulatory reference points.

44 services shift to Emirates Drug Establishment

The restructuring includes the full transfer of 44 core services to the EDE, which will administrate, regulate, and provide oversight for these services.

Among some of the services that have been transferred to EHE are…

• Re-pricing of individual medical products
• Registration and renewal of manufacturers of medical products
• Issuance of certificates for pharmaceutical products intended for export
• Renewal of registration for pharmaceutical products derived from natural sources
• Publication of price lists for regulated medicines
• Issuance of accreditation certificates for clinical studies or bioequivalence centres
• Issuance of certificates reflecting amendments to registered pharmaceutical products
• Analysis of medical products for pharmaceutical companies and their subsidiaries
• Issuance of quality reports for medical products by drug quality control laboratories
• Approval of pharmacovigilance (PCV) officers
• Approval of PCV plans for medical products
• Publication of price lists for controlled and semi-controlled drugs
• Authorisation for pharmaceutical entities to destroy drug products
• Requests for the registration of custody records for controlled or semi-controlled drugs

Among the 13 services that MoHAP partially transferred to EDE are…

• Licensing, renewal, reactivation, amendment, and cancellation of pharmaceutical facility
• Publication of the list of licensed pharmaceutical facilities in the UAE
• Issuance and renewal of health advertising licences
• Handling of appeals against health advertising violations
• Receipt and processing of complaints against private health facilities and their personnel
• Approval of emergency drugs and psychotropic substances
• Requests for the handover of custody of narcotic drugs
• Approval of authorised signatories responsible for narcotic drug custody
• Requests for the registration of narcotic drugs distributed to private health establishments

The ministry said these five services related to the pharmaceutical sector will remain fully within the jurisdiction of MoHAP…

• Issuance of controlled-medicine prescription books
• Authorisation of narcotic drug custody for hospitals
• Determination or modification of narcotic drug quotas for private healthcare facilities or pharmaceutical establishments
• Approval of narcotic drugs for in-house pharmacies in private hospitals
• Approval of narcotic drugs for day-surgery centres

The move will also ensure clear mandates and communication channels, in line with the objectives of the Zero Government Bureaucracy Programme, which aims to simplify procedures and accelerate service delivery.