MoHAP hands over several pharmacy related services to the Emirates Drug Establishment
The UAE is making several changes to the regulatory framework governing the pharmaceutical sector, with the Ministry of Health and Prevention (MoHAP) transferring many of its services to the Emirates Drug Establishment (EDE).
Organizational change will help restructure regulatory and supervisory roles within the health care sector. It will ensure clarity about the authority responsible for each service, especially in areas related to the control of drugs, medical devices, and related health products.
MoHAP added that the transfer of these services to EDE does not represent a change in its obligations to customers, but rather a redistribution of obligations in accordance with the governing law. This management approach not only improves the flexibility of the health care system and improves the customer journey by reducing contact points, but also accelerates decision-making cycles, and consolidates control reference points.
44 services transfer to Emirates Drug Establishment
The reorganization includes the complete transfer of 44 core services to EDE, which will manage, manage, and provide oversight of these services.
Among some of the services outsourced to EHE are…
- Re-instating the price of individual medical products
- Registration and renewal of manufacturers of medical products
- Issuance of certificates for pharmaceutical products intended for export
- Renewal of registration of medicinal products derived from natural sources
- Publication of price list of controlled drugs
- Issuance of authorization certificates for clinical studies or bioequivalence centers
- Issuance of certificates indicating amendments to registered medicinal products
- Analysis of medical products of pharmaceutical companies and their subsidiaries
- Issuance of quality reports for medicinal products by drug quality control laboratories
- Authorization of pharmacovigilance officers (PCV).
- Approval of PCV systems for medical products
- Publication of price lists of controlled and semi-controlled drugs
- Authorization of pharmaceutical companies to destroy drug products
- Requests for the registration of records for the possession of controlled or semi-controlled drugs
Among the 13 services that MoHAP partially transferred to EDE are…
- Licensing, renewal, renewal, amendment, and cancellation of pharmaceutical establishment
- Publication of a list of licensed medical facilities in the UAE
- Issuance and renewal of health promotion licenses
- Handling of complaints against health advertising violations
- Acceptance and processing of complaints against private health centers and their employees
- Authorization of emergency drugs and psychotropic substances
- Requests for the provision of drug custody
- Authorization of authorized signatories responsible for the storage of narcotic drugs
- Applications for registration of drugs distributed in private health facilities
The ministry said that these five services related to the pharmaceutical industry will remain fully under the MoHAP…
- Issuance of prescriptions for controlled drugs
- Authorization for storage of narcotic drugs in hospitals
- Determining or changing the allocation of narcotic drugs in private health centers or pharmaceutical centers
- Authorization of narcotic drugs for in-house pharmacies in private hospitals
- Authorization of narcotic drugs for day surgery centers
This initiative will also ensure clear authority and channels of communication, in line with the objectives of the Government’s Governance Plan, aimed at simplifying procedures and speeding up the provision of basic services.
