Topic -1 Pharmacy Law Regulatory Affairs PDF

College of Health Sciences School of Pharmacy Social, Administrative & Legal Aspects of Pharmacy Practice (PHCY306) Topic -1 Part-1...

College of Health Sciences School of Pharmacy Social, Administrative & Legal Aspects of Pharmacy Practice (PHCY306) Topic -1 Part-1 Pharmacy Law & Regulatory Affairs in Oman Ph. Sujith Haridass, M. Pharm Clinical Instructor School of Pharmacy, CPN University of Nizwa 9/8/2024 1 Learning outcomes At the end of this topic, students should be able to: - Define law and regulation - Recognize the regulatory bodies responsible for drug control activities in Oman. - Discuss various departments of Drug Safety Center (DSC) - Describe the services offered by various departments of Drug Safety Center (DSC) - Discuss the responsibilities of various technical committees in Drug Safety Center (DSC) 9/8/2024 2 Definitions Law : The law is a set of rules for society, designed to protect basic rights and freedoms, and to treat everyone fairly. These rules we must obey or else we will be penalized. Law of Pharmacy practice in Oman is primarily intended to legally restrict the sale or supply medicinal products and poisons. Regulation : Are rules made by a government or other authority in order to control the way something is done or the way people behave. 9/8/2024 3 Definitions cont… Ministry of Health (MOH) : The Ministry of Health is the Sultanate's main agency responsible for provision, coordination and stewardship of the health sector. Ministry of Health (MOH) undertakes drug control through the Drug Safety center (DSC) 9/8/2024 4  Definitions cont….. Drug Safety center (DSC) Drug Safety Center is the Regulatory body which is responsible for the assurance of effective, safe and good quality drugs in Oman whether manufactured locally in Oman or exported from outside the sultanate, and that will be achieved by implementing the Pharmacy Practice Law issued against the Royal Decree No 41/ 91 and its amendments. 9/8/2024 5 Definitions cont.….. Drug/Medication : Anything comprising of one or more substances used to diagnose, prevent, or treat diseases in humans or animals. Medical Supplies: Any device, material, tool, or product that is used alone or in conjunction with others, including the software necessary for human use with the aim of treatment, diagnosis, prevention, or alleviation of disease, or regulating pregnancy. Toxins: Any substance whose intake by its nature causes danger to the life of a living organism or leads to organ damage or death, whether it is taken orally, inhaled, injected, used locally , or in any other way. 9/8/2024 6 Definitions cont….. Pharmacy profession : Includes the processing, compounding, manufacturing, packing, storing, importing, exporting, selling or distributing medicine. Licensed Pharmacist : Holder of a bachelor degree in pharmacy or equivalent from a recognized university or a higher institute who is licensed to practice the profession according to law. Licensed Assistant Pharmacist : Holder of a diploma degree in pharmacy or equivalent from a recognized institution who is licensed to practice the profession under the supervision of the Licensed Pharmacist. 9/8/2024 7  Departments in Drug Safety Center 1. Pharmacy Licensing Department This department has three (3) sections a. Pharmaceutical establishment licensing section , b. Pharmacist and assistant pharmacist licensing section c. Follow-up & evaluation section Services of Pharmacy Licensing department ✓Licensing and renewal of pharmaceutical establishment (PE) licenses. ✓Licensing and renewal of pharmacist and assistant pharmacist licenses. ✓Carrying out the inspection for the pharmaceutical establishments to assure the enforcement of practice law issued against the royal decree no. 41/ 96 and its ministerial decisions. 9/8/2024 8  Departments in Drug Safety Center cont… 2.Drug Control Department This department has five (5) sections a. Human Drug Registration Section b. Herbal Drugs & Health Product Registration Section c. Controlled Drugs Section d. Drug Pricing Section e. Drug Clearance & Export Section Services of Drug Control Department ✓ Regulation of the import of medicines into the Sultanate by registering pharmaceutical companies and registering and pricing medicines. ✓ Regulation of the import, export and circulation of controlled medicines in the health sector. ✓ Undertakes the procedures for releasing all medical products that fall within its jurisdiction from customs ports. 9/8/2024 9 Departments in Drug Safety Center cont… 3. Central Quality Control Department Central quality control department: - Includes a number of sections: a. Quality Assurance Section b. Chemical Analysis Section, c. Physical Analysis Section d. Herbal Medicine & Health Products Section e. Receiving and follow-up analysis requirements Section f. Microbiological Analysis Section g. Biotechnology & Pharmacological Analysis Section. Services of quality control department ✓ Carry out drug analysis including samples for registration as well as pharmaceutical products that are imported from outside the country to assure that they meet the standard specification. 9/8/2024 10 Departments in Drug Safety Center cont… 4. Pharmacovigilance and Drug Information (DPV&DI) Department This department has three (3) Sections a. Pharmacovigilance of Human Medicines Section, b. Pharmacovigilance of Herbal Medicines & Health Product Section c. Drug Information Section. Objectives of this department ✓ Post-marketing surveillance of medicines.To receive, evaluate and analyze reports of side effects/ adverse reactions and problems associated with medication such as quality defects and medication errors and to take possible action. ✓ Promote awareness on public health and safety by responding to enquiries on information related to medicines and their effects. ✓ Coordinate with local health institutions and International Pharmacovigilance collaborating centers to prevent frequency and adverse effects of drugs. ✓ Preparing and circulating periodic and annual reports on the received notifications of adverse drug reaction reports in the Sultanate. 9/8/2024 11  Departments in Drug Safety Center cont… Equipment and Medical Devices Control Department: The Medical Devices Control Department includes four sections: a. Medical Device Registration Section, b. Surgical Instruments Registration Section, c. In Vitro Diagnostic Devices Registration Section d. Medical Device Vigilance Section. Services of Medical Devices Control Department: ✓Registration of medical, in-vitro diagnostic devices & surgical imported to Oman or manufactured in Oman. ✓Registration manufacturers of medical devices. ✓Receiving all adverse events that may be associated with medical devices & supplies and to set the necessary requirements to ensure the quality of medical devices and supplies. 9/8/2024 12 Pharmaceutical Technical Committees in the Drug Safety Center Pharmaceutical technical committees are constituted upon ministerial decisions, each of the committee has certain responsibilities. 1. Pharmaceutical Licensing Committee: Responsibilities of this committee include ✓ Approval of the licensing request for pharmacists and assistant pharmacists. ✓ Approval of licensing request for Pharmaceutical establishments (PE) 9/8/2024 13 Pharmaceutical Technical Committees in the Drug Safety Center cont.…. 2. Pharmaceutical Violation Committee: Responsibilities of this committee include ✓To ensure that the professional standards for practicing pharmacist and assistant pharmacist are maintained. ✓ To decide upon offences arising from non- compliance of Pharmacy Law of Oman. 9/8/2024 14 Pharmaceutical Technical Committees in the Drug Safety Center cont.…. 3. Technical Committee for Registration of Pharmaceutical Companies: Responsibilities of this committee include ✓ Approval of registration requests of Pharmaceutical companies, Pharmaceutical products and the pricing of pharmaceutical products. ✓ Recommendation on banning and trading of pharmaceutical products that will harm people and animals. 9/8/2024 15 Pharmaceutical Technical Committees in the Drug Safety Center cont.…. 4. Narcotic and Psychotropic committee: Responsibilities of this committee include ✓Safe disposal of expired/spoiled/damaged narcotic, psychotropic medications received from Health institutions and Pharmaceutical establishments. 9/8/2024 16  References Website https://www.moh.gov.om/en/hospitals- directorates/directorates-and-centers-at-hq/drug-safety- center/#Home Law of organization of pharmacy practice and pharmaceutical establishments no 35/2015 (2015) Guidelines. Ministry of Health, Directorate General of Pharmaceutical Affairs and Drug Control. Available at: https://www.moh.gov.om/en/hospitals- directorates/directorates-and-centers-at-hq/drug-safety- center/#Section1 9/8/2024 17