Legislation Details
- Full Title: Cabinet Resolution Concerning the Executive Regulations of Federal Law Concerning Medical Products, Pharmacy Profession and Pharmaceutical Establishments
- Law Type: Federal Law
- Law Number: 90 of 2021
- Issued Date: 28 Sep 2021
- Effective Date: 15 Jan 2021
- Official Gazette: No. 713
- Sector: Healthcare
- Status: Active
- Number of Articles: 84
- Chapters/Parts: 0
- Amendments: 0
Summary
This Cabinet Resolution establishes the executive regulations for Federal Law No. (8) of 2019 on Medical Products, Pharmacy Profession and Pharmaceutical Establishments. It provides detailed rules and requirements governing the pricing, suspension, import, and distribution of medical products in the UAE. The Resolution also regulates the licensing and practice of the pharmacy profession, including obligations for pharmacists, pharmacy technicians, and non-pharmaceutical establishments that sell over-the-counter (OTC) medical products. The legislation aims to ensure the quality, safety, and proper handling of medical products and the pharmacy profession in the UAE. (Cabinet Resolution Concerning the Executive Regulations of Federal Law Concerning Medical Products, Pharmacy Profession and Pharmaceutical Establishments, 2021)
What is the scope and purpose of this law?
The scope of this Cabinet Resolution is to provide the executive regulations for Federal Law No. (8) of 2019 on Medical Products, Pharmacy Profession and Pharmaceutical Establishments. It applies to all individuals and entities involved in the medical products industry, pharmacy profession, and pharmaceutical establishments in the UAE. The purpose is to regulate the pricing, suspension, import, and distribution of medical products, as well as the licensing and practice of the pharmacy profession, in order to ensure the quality, safety, and proper handling of medical products and the pharmacy sector. (Cabinet Resolution Concerning the Executive Regulations of Federal Law Concerning Medical Products, Pharmacy Profession and Pharmaceutical Establishments, 2021, Art. 1)
What are the key definitions under this law?
The Resolution provides the following key definitions:
- Health Authority: Any federal or local government entity concerned with health affairs in the UAE.
- Product Suspension: Suspension of the circulation or use of the product.
- Healthcare Profession: A health profession licensed to be practiced in the UAE, as determined in Cabinet Resolution No. (20) of 2017.
- Narcotic Drug: A medical product that contains any of the active ingredients listed in Schedules Nos. (1,2,3 or 4) of Federal Law No. (14) of 1995 on the Combating of Narcotic Drugs and Psychotropic Substances.
- Psychotropic Substance: A medical product that contains any of the ingredients listed in Schedules Nos. (5,6,7 or 8) of Federal Law No. (14) of 1995.
- Controlled Substances: Narcotic drugs and Psychotropic Substances.
- Visiting Pharmacist: A pharmacist licensed in a pharmaceutical establishment or health facility in the UAE and permitted to work on a part-time basis for another establishment, or a pharmacist coming from abroad to practice in the UAE for a specified period.
(Cabinet Resolution Concerning the Executive Regulations of Federal Law Concerning Medical Products, Pharmacy Profession and Pharmaceutical Establishments, 2021, Art. 1)
What are the main obligations and requirements?
The Resolution imposes the following key obligations: 1. Pharmacists and pharmacy technicians must be licensed by the Health Authority to practice their profession in the UAE. (Art. 6) 2. Pharmacists must adhere to the scope of work and area of activity defined in their license and perform their duties accurately and honestly. (Art. 10) 3. Non-pharmaceutical establishments permitted to sell OTC medical products must purchase them from a licensed warehouse, adhere to the approved OTC product classification, obtain approval from the licensing entity, comply with storage conditions, and follow the Ministry-set prices. (Art. 5) 4. Medical prescriptions must meet specific requirements, such as being written in non-erasable material, containing electronic signatures, and adhering to time limits. (Art. 12) 5. Pharmacies must comply with specific requirements for the custody and dispensing of controlled substances and products. (Arts. 13, 15, 30, 32) (Cabinet Resolution Concerning the Executive Regulations of Federal Law Concerning Medical Products, Pharmacy Profession and Pharmaceutical Establishments, 2021)
What licensing, registration, or approval requirements exist?
The Resolution outlines the following key licensing and registration requirements: - Pharmacists and pharmacy technicians must be licensed by the Health Authority to practice their profession in the UAE. (Art. 6) - The Health Authority is responsible for considering and deciding on applications for licensing or renewing licenses to practice the pharmacy profession and pharmacy technician profession. (Art. 8) - Specific requirements and controls are provided for issuing temporary licenses to visiting pharmacists, both from within the UAE and from outside. (Art. 9) - Non-pharmaceutical establishments permitted to sell OTC medical products must obtain approval from the entity licensing the establishment. (Art. 5) (Cabinet Resolution Concerning the Executive Regulations of Federal Law Concerning Medical Products, Pharmacy Profession and Pharmaceutical Establishments, 2021)
What rights and protections does this law provide?
The Resolution does not explicitly outline any specific rights or protections provided under this legislation. The focus is on regulating the medical products industry, pharmacy profession, and pharmaceutical establishments in the UAE through detailed obligations and requirements. (Cabinet Resolution Concerning the Executive Regulations of Federal Law Concerning Medical Products, Pharmacy Profession and Pharmaceutical Establishments, 2021)
Which authorities or bodies are responsible for enforcement?
The key authorities and bodies responsible for enforcement under this Resolution are: - The Health Authority: Responsible for licensing and regulating pharmacists, pharmacy technicians, and healthcare professions in the UAE. (Arts. 6-9) - The Body Concerned: May suspend the circulation of medical products at public and private health facilities and report to the Ministry. (Art. 3) - The Ministry of Health and Prevention: Responsible for setting prices, approving OTC product classifications, and taking necessary decisions regarding product suspensions. (Arts. 2, 3, 5) (Cabinet Resolution Concerning the Executive Regulations of Federal Law Concerning Medical Products, Pharmacy Profession and Pharmaceutical Establishments, 2021)
What are the penalties for non-compliance?
The Resolution does not specify any penalties for non-compliance. The focus is on outlining the detailed obligations and requirements for medical products, the pharmacy profession, and pharmaceutical establishments, without detailing enforcement mechanisms or sanctions. (Cabinet Resolution Concerning the Executive Regulations of Federal Law Concerning Medical Products, Pharmacy Profession and Pharmaceutical Establishments, 2021)
What fees, charges, or financial provisions are specified?
The Resolution does not specify any fees, charges, or financial provisions. It is focused on regulating the medical products industry and pharmacy profession through obligations and requirements, without addressing financial aspects. (Cabinet Resolution Concerning the Executive Regulations of Federal Law Concerning Medical Products, Pharmacy Profession and Pharmaceutical Establishments, 2021)
What exemptions or exceptions apply?
The Resolution does not outline any explicit exemptions or exceptions. It provides a comprehensive set of regulations applicable to the medical products industry, pharmacy profession, and pharmaceutical establishments in the UAE. (Cabinet Resolution Concerning the Executive Regulations of Federal Law Concerning Medical Products, Pharmacy Profession and Pharmaceutical Establishments, 2021)
How are disputes resolved under this law?
The Resolution does not specify any dispute resolution mechanisms or procedures. It is focused on establishing the regulatory framework for medical products, the pharmacy profession, and pharmaceutical establishments, without addressing dispute resolution. (Cabinet Resolution Concerning the Executive Regulations of Federal Law Concerning Medical Products, Pharmacy Profession and Pharmaceutical Establishments, 2021)
What are the key deadlines and time limits?
The Resolution outlines the following key deadlines and time limits: 1. The Body Concerned must report the suspension of a medical product's circulation to the Ministry within 24 hours. (Art. 3) 2. Medical prescriptions must not be issued for more than 60 days, unless they contain controlled substances or products. (Art. 12) 3. Drugs may not be dispensed against repeat dispensing prescriptions if 30 days have passed since the date set by the physician for repeat dispensing. (Art. 12) (Cabinet Resolution Concerning the Executive Regulations of Federal Law Concerning Medical Products, Pharmacy Profession and Pharmaceutical Establishments, 2021, Arts. 3, 12)
How does this law interact with other UAE legislation?
The Resolution references and interacts with the following UAE legislation: - Federal Law No. (8) of 2019 on Medical Products, Pharmacy Profession and Pharmaceutical Establishments (the "Law") - Federal Law No. (14) of 1995 on the Combating of Narcotic Drugs and Psychotropic Substances - Federal Law No. (2) of 2019 on the Use of Information and Communication Technology in Health Fields - Cabinet Resolution No. (20) of 2017 Approving the Unified Standards for Licensing Health Professionals at the State's Level - Cabinet Resolution No. (32) of 2020 on the Executive Regulations of Federal Law No. (2) of 2019 on the Use of Information and Communication Technology in Health Fields (Cabinet Resolution Concerning the Executive Regulations of Federal Law Concerning Medical Products, Pharmacy Profession and Pharmaceutical Establishments, 2021)
When did this law come into effect?
This Cabinet Resolution came into effect on 15 January 2021, as stated in the "Effective Date" field. The Resolution was issued on 28 September 2021 and published in the Official Gazette No. 713 on 14 October 2021. (Cabinet Resolution Concerning the Executive Regulations of Federal Law Concerning Medical Products, Pharmacy Profession and Pharmaceutical Establishments, 2021)
Source Documents
This article analyses Cabinet Resolution Concerning the Executive Regulations of Federal Law Concerning Medical Products, Pharmacy Profession and Pharmaceutical Establishments for legal research and educational purposes. For the purpose of interpretation and application, reference must be made to the original Arabic text. In case of conflict, the Arabic text prevails. This does not constitute legal advice.