UAE Pharmacy Law & Legislation PDF

Summary

This document provides an overview of pharmacy law and legislation in the UAE, covering terminology, principles, and relevant authorities. It details aspects like the role of health authorities, the profession of pharmacy, and types of pharmaceutical facilities.

Full Transcript

Pharmacy Law & Legislation in UAE Terminology & Principles Pharmacy Law Federal Law No. (8) of 2019 on Medical Products, the Profession of Pharmacy and Pharmaceutical Facilities Health Law and legislation in the UAE - Authorities Ministry of Health and Prevention (MoHaP...

Pharmacy Law & Legislation in UAE Terminology & Principles Pharmacy Law Federal Law No. (8) of 2019 on Medical Products, the Profession of Pharmacy and Pharmaceutical Facilities Health Law and legislation in the UAE - Authorities Ministry of Health and Prevention (MoHaP) or (MOH) Department of Health - Abu Dhabi (DOH) Dubai Health Authority (DHA) Ministry of Health and Prevention It is a federal health authority. Creating and ensuring the execution of policies and strategies for healthcare in healthcare sectors. Implementation of healthcare policy in all areas of technical, material, and cooperation with the private sector in health locally and internationally. Provides comprehensive healthcare to all citizens and residents through its preventive and curative health services, mainly to the Northern Emirates: Sharjah, Ajman, Umm Al Quwain, Ras Al Khaimah and Fujairah. department of health dubai health authority DOH and DHA Local Authorities Regulate both the public and private healthcare sectors through policies, laws, regulations, inspections and audits. Provides healthcare services through hospitals and other facilities that fall under its direct jurisdiction. Enabling partnerships between healthcare providers. Licensing and regulating medical professionals and facilities. Profession of Pharmacy A healthcare profession that aims at improving the health standard of medical product users through proper and appropriate usage of such products, based on specialized scientific knowledge. The profession of pharmacy includes a number of licensed activities to be practiced by the pharmacist and shall not be limited to manufacturing, composition, dispensing, administration, sale and storage of medical products, or providing pharmaceutical advises, however, it includes any other activities determined by a ministerial resolution. It also includes a variety of healthcare services to the patients, directly or through an assistance for other licensed healthcare practitioners, by communicating and providing clinical (technical and scientific) advices. Pharmacist A person who holds a scientific qualification no less than bachelor of pharmacy or an equivalent degree from a higher institution, college or university recognized in the country. A pharmacist must be licensed to practice pharmacy within the country according to this Law and its executive decree. Pharmacist In-Charge A licensed pharmacist for a licensed pharmacy. The pharmacist shall be responsible of implementing the provisions of the Law and its executive decree within the limits of assigned tasks. Pharmaceutical Facility A facility licensed to operate in any discipline of the profession of pharmacy within the country, including pharmacy, pharmacy chain, medical warehouse, marketing offices, marketing consultation offices, pharmaceutical laboratory, pharmaceutical research offices, factory and other facilities stipulated by the executive decree of this Law. Pharmacy The facility licensed to store, prepare, compound, dispense, display or directly sell the medical products to the public through a fixed or mobile, permanent or temporary facility. Pharmacy Chain A number of pharmacies owned by a natural or legal person under the same name. Clinical Pharmacy A branch of pharmacy based on scientific knowledge to ensure utmost patient benefit from medication treatment greatest plan, cure, health enhancement, and disease or complication prevention. Clinical Pharmacist A person who holds approved clinical pharmacy certificates and has extensive experience in this field. A Clinical pharmacist develops treatment plans for patients, including usage of medical products based on scientific analysis of the patient's condition as well as a report on patient's diagnosis. Further, clinical pharmacists provides professional advices on therapeutic treatment plan and the optimal application of pharmaceutical products for healthcare practitioners, who are members of medical staff responsible of the patient, and the patient himself. Medical Product All drugs, medical devices or healthcare products. Drugs Any product that contains an active ingredient or a group of active ingredients that accomplish the intended purpose when applied on/in human or animal through a biological effect. This product is manufactured, sold or made available to be applied in the following cases: 1. Diagnosis, treatment, cure, relief, or prevention of illness 2. Restoration, renovation, modification or correction of organ's functions. Healthcare Product Any medical product used for general health of a human and not specific for the diagnosis, treatment or cure, which does not require a prescription on dispensing or direct medical supervision when applied. Pharmaceutical Product A medical pharmaceutical product that is produced in a specific approach and has specific applications for human and animal. Medical Prescription A written or electronic document issued by healthcare professional a duly licensed to dispense according to the executive decree of this Law, resolutions, orders and instructions issued in this regard. Further, oral order issued by a healthcare professional is deemed a prescription, provided it must be documented later according to a ministerial resolution. Narcotic and Psychotropic Substances Medical and therapeutic products and others containing any of the active ingredients according to Federal Law No. 14 of 1995, and its amendments. Ministerial Decree No. (888) for the year 2016: This group includes all the medical and pharmaceutical products that contain any of the active ingredients listed in International Narcotics Control Board (INCB) schedules Nos. (1,2,3,4) in accordance with the Single Convention on Narcotic Drugs of 1961 and as amended in the protocol of 1972 , and Schedules mentioned in the Federal Law No. 14 of 1995 in respect of combating Narcotic drugs and Psychotropic substances and its amendments according to the Cabinet Decree No. (38) Of 2015 List of narcotic drugs under International Control https://www.incb.org/documents/Narcotic- Drugs/Yellow_List/57th_edition/57th_edition_YL_ENG.pdf Pharmacy Technician A person who holds a scientific qualification no less than diploma of pharmacy, with a study duration must not be less than two years after secondary school or an equivalent, from a recognized authority in the country. Pharmacy technician must be licensed to practice pharmacy technician profession under the direct supervision of a licensed pharmacist according to the provisions of this Law. Pharmacy Technician Assistant allied healthcare professionals cannot work independently and shall work under a licensed Allied Healthcare professional. Diploma in Pharmacy program (Minimum two (2) years course duration) Minimum of two (2) years’ experience post qualification in related field Pharmacy Technician experience with pharmaceutical companies or sales representative is not accepted. Pharmacy Technician Job Duties (internal responsibilities) … 1 Dispenses prescription medication and other medical products to patients under direction of licensed pharmacist Counts pills, labels bottles, prices, and compounds medications to prepare prescriptions for patients as directed Performs administrative duties, including answering phones, receiving and inputting prescription orders, operating cash registers, and restocking inventory Gathers, organizes, and assesses patient information Monitors prescription-filling process to ensure compliance with relevant regulations and pharmacy policies Pharmacy Technician Job Duties (internal responsibilities) … 2 Answers patients' questions about their medications under the supervision of the pharmacist Takes inventory of drugs on hand and records results Places orders for additional drugs as directed by the pharmacist Maintains electronic patient information Prepares billing information for medications Completes patients' sales transactions for purchase of prescription and over-the-counter medications as well as other pharmaceutical products Telepharmacy Is the delivery of pharmaceutical care through telehealth technology and includes prescribing and dispensing of medications, medical products, herbal, food supplements, cosmetic products, formulary compliance, patient counselling, medicine therapy management, automated packaging and labelling systems. Dubai Health Authority, 2020. STANDARDS FOR TELEHEALTH SERVICES https://www.dha.gov.ae/Documents/HRD/RegulationsandStandards/standards/Standards%20for%20Telehealth%20Services%20Final.pdf

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