PHARMACY LAW Kf 7 _ EVELYN HONE COLLEGE PHARMACY SECTION ed FY eee LECTURE OBJECTIVES Discus the: > The MASA in detail Mandate, vision, and mission of ZAMRA Functions of ZAMRA + History of medicines regulation in Zambia » Categorias of medicines regulated by ZAMRA > Categories of medicines not regulated by ZAMRA Requirements for establishment of a pharmaceutical business ~ Pharmaceutical businesses regulated by ZAMRA ~_Discuss the key ZAMRA stakeholders & their roles, History & Evolution of Zambia Medicines Regulatory Authority (1) = The history of medicines regulation in Zambia dates back to 1941 when the Pharmacy and Poisons Act, Chapter 299 of the Laws of Zambia was first enacted. = This Act was to provide for the control of the profession of pharmacy and trade in drugs and poisons = The Pharmacy and Poisons Board (PPB) was established under this law to oversee [History & Evolution of Zambia Medicines Regulatory Authority (2) ® Other legisiation. enacted to regulate medicines and allied substances include the «The Dangerous Drugs Act of 1967; 9 The Therapeutic Substances Act, Chapter 310 of 1967; 9 The Food and Drugs Act, Chapter 303 of 1972; 9 The Public Health Act, Chapter 295;and 2 The Narcotic Drugs and Psychotropic Substances Act, Chapter 96 of 1993 —its enforcement. [History & Evolution of Zambia Medicines Regulatory Authority (3) ‘= In 1997 the Zambia National Qrug Policy was approved by the Cabinet f= The approval and subsequent taunch of the National Orug Policy (NOP) by the Minister for Health in February 1999 reflects the Governments commitment to address issues affecting the pharmaceutical sector in a more comprehensive ‘= One of the key elements of policy commitment was the plan to yatem for control of importation, distribution and supply of medicines and slied substances and the practice of pharmacy with a view to ensure affective enforcement of such legisition Establishment of the Pharmaceutical Regulatory Authority... * The Pharmaceutical Act (No.14) of 2004 established the Pharmaceutical Regulatory Authority (PRA); 1 The functions of the Authority are cl fi Ape ly are clearly defined under 1 The foregoing Act has been repealed and replaced by the Medicines and Allied Substances Act No. 3 of 2013 that continuous the existence of PRA as Zambia Medicines Regulatory Authority (ZAMRA) « Therefore, ZAMRA is the Natinonal Medicines Regulatory Authority for Zambia ea eeMandate, Mission & Vision of ZAMRA = Mandate: Regulating and monitoring the entire pharmaceutical Industry in Zambia = Mission Statement: To effectively regulate and control pharmaceutical products made available to the Zambian population to ensure conformity to set standards thereby safeguarding public health = Vision: To be one of the leading Pharmaceutical Regulatory Authorites in the African Region by 2030. [ZAMRA Organisational Stracture = ZAMRA has currently 3 Key Departments and these are: yer ~ Department of Medicines Control which has two sections namely Section of Marketing Authorization & Section of Licensing, Sureeillance and Enforcement > Department of Laboratory Services (National Drug Quality Control Laboratory-NDQCL) ~ Department of Administrative Services wok palit [Function of the Departments # The functions of the Department of Medicines Control are carried out by the two sections: + Marketing Authorization: Major functions > Conducting Registration of medicines & Allied ‘Substances and allocating marketing authorization.numbers to each registered product. Marketing Authorization is the authorization granted to the manufacturer of a particular product in order for the product to be placed on the Zambian market for sale or use [Function of the Departments > Conducting Pharmacovigilance activities. Pharmacovigilance is the practice of monitoring the effects of medicinal products after they have been licensed for use, especially in order to identify and evaluate previously unreported adverse reactions. It is the science and activities relating to the detection, assessment, understanding and prevention of adverse effects or any other drug-related problem Function of the Departments + Monitoring of the conduct of clinical trials. Clinical trial is the systematic study involving human beings or animals that helps evaluate the efficacy of a medicine, biological products cor methods of prevention or treatment -- Monitoring and control of advertising and promotion of medicines and allied substances [Function of the Departments + Licensing, Surveillance and Enforcement: Major Functions: » Licensing of premises meant for conducting pharmaceutical businesses. These pharmaceutical businesses include Retail Pharmacies, Dispensing Chemists harmaceutical busi 5 Wrmaceutal product Manufacturing site Health-shops, Agroveterinary Shops, et[Function of the Departments Licensing & monitoring importation and exportation and movement of medicinal products meant for either commercial purpose, personal use, or donation (charity) Inspection of premises involved in the sale of medicines and allied substances. These premises include retail pharmacies, dispensing chemists, pharmaceutical wholesale, ‘manufacturing, health shops, agro-veterinary shops, hospital pharmacies [Function of the Departments ‘Types of Inspections conducted: Pre-Licensing inspection: These are inspections conducted on premises intended to be used for conducting any pharmaceutical business « Post-Licensing inspection: These are planned inspections conducted on already registered premises being used for conducting any pharmaceutical business [Bunction of the Departments + Spot-check inspections: These are abrupt, planned or unplanned inspections conducted on already registered premises being used for conducting any pharmaceutical business so as to ascertain compliance of the premises in certain areas as may be desired and determined by the inspectors «+ Triggered Inspections: These are inspections conducted based on gathered or received information by ZAMRA or complaint received from any member of the public [Bunction of the Departments + Conducting post-marketing surveillance inspections: Post-marketing surveillance (PMS) is the practice of monitoring the safety of a pharmaceutical drug or medical device after it has been released on the market. This activity involves sampling of products for Assessment of the conformity of the products to labelling requirements and re-evaluation (testing) of the product for quality, safety and efficacy at the NDQC [Function of the Departments = Department of Laboratory Services. This is the National Drug Quality Control Laboratory (NDQCL) The major function of this department is to evaluate/test medicinal products for 3 aspects: + Quality + Safety » Efficacy [List of Key Stakeholders of ZAMRA These are involved in enforcement activities related to regulation of medicines, Allied Substances & pharmaceutical businesses: They include the following institutions: + Health Professions Council of Zambia (HPCZ) + Drug Enforcement Commission (DEC), > Zambia Bureau of Standards (ZABS) + Local Authority (Councils) aer [List of Key Stakeholders of ZAMRA ~ Customs (ZRA > Veterinary Council Of Zambia > Zambia Police (ZPS) + Competition & Consumer Protection Commission (CCPC) > Zambia Evironmental Management Agency (ZEMA) BASIS FOR REGULATION OF MEDICINES AND LIED SUBSTANCES = Components forming basis for regulation of Medicines, Allied Substances & Pharmaceutical businesses in Zambia are: > Manufacture of products > Importation of Samples for registration > Registration of products > Importation & Exportation of registered products > Transportation/movement, Sale (Retail or Bulky) of products Dispensing and use of Medicines & Allied Jbstances— + Disposal of expired/unwanted Medicines & Allied [Categories of medicines regulated by ZAMRA + Conventional Medicines (Human Medicines) > Herbal Medicines > Veterinary Medicines [ALTERNATIVE MEDICINES = An Alternative medicine is any practice that is put forward as having the healing effects of ‘medicine, but does not originate from evidence gathered using the scientific method: e.g. African Traditional, Acupuncture, Ayurveda, Homeopathy, Naturopathy, Chinese or Oriental medicine, etc. = The regulation of Alternative Medicines is NOT currently conducted in Zambia. [Process of Registration of Medicines 1» The steps in medicinal product registration: > Manufacture of product > Submission of information (Dossier) on the product wished to be registered and samples ‘of the product. The information include the following: + Name of the product (Generic & Brand) + Processes, raw materials and equipment used in the manufacture of the product [Process of Registration of Medicines Indications and contraindications of the product + Side effects of the products + How the product should be used + Special studies conducted on the products ‘A pharmaceutical product Dossier is 2 collection ofall he required information on & harmaceutical produ: forthe pupoee of registration of the product[Process of Registration of Medicine > Evaluation of dossier and ‘samples. The dossier evaluation involves checking up the conformity of information submitted by the manufacturer on the product to the set standards or requirements. The samples submitted are tested by the NDQCL for: Quality, Safety and Efficacy > Product is either accepted for registration or rejected. If accepted, unique Marketing Authorization Number is allocated to the product and when rejected, no MA # allocated and therefore, the product cannot be placed on the Zambian market ESTHER | Process of Registration of Medicine The product is then placed on the market and Is only authorized to be accessed (bought or sold or dispensed) from registered pharmaceutical outlets or dispensed or administered from registered health facilities only. Retail outlets are not authorized to supply medicines or allied substances on wholesale basis and wholesale outlets are not authorized to dispense medicines (Retail) PHIR| CATEGORIES OF MEDICINES DISTRIBUTION = Prescription-Only medicines (POM): These are medicines stocked in the dispensary of a pharmacy and can only be dispensed by a registered pharmacist upon presentation of a prescription by the patient/ctient = Pharmacy Medicines (P): These are medicines which are only stocked in a pharmacy and can only be dispensed by a registered pharmacist with or without presentation of a prescription by the patient/client. [ CATEGORIES OF MEDICINES DISTRIBUTION They may be stocked in the front shop as part of the Over-the-Counter (OTC) medicines or in the dispensary = General Sale Medicines (GS): These are medicines which can be sold or dispensed from any licensed premises by any individual provided the individual is able to read and write [Requirement on pharmaceutical business premises = Medicines storage area should be clean and air-conditioned «= Refrigeration system should be installed for ‘storage of cold-chain/biological medicinal products ‘= Temperature-monitoring facilities should be installed. These include thermometers and daily temperature-recording charts = Pharmacists & Pharmacy Technologists should be present at all times [Requirement on pharmaceutical sDBISIRGSE REGRESS Ret labeled of the name of the facility (outlet) on white background and ‘should have PLUS sign(+) or cross in Green Colour = Premises Registration documents from ZAMRA, Local Authority (council), and Patents (PACRA)should be displayed on the premises. Documents from PAGRA are called Certificate of Incorporation or Certificate of Registration and those from the council are Trading Permit and Fire Safety CertificateI Requirement on pharmaceutical business premises « Registration and practicing certificates for the pharmacist(s) and pharmacy Technologist(s) by HPCZ should be displayed on the premises. | Requirement on pharmaceutical business premises. - = The Pharmacist (s)/Pharmacy Technologist should always be dressed in clean white clinical coat whenever handling medicines or attending to patients in a retail pharmacy = Ina retail outlet, the following should also be available: Distilled water, measuring Cylinder, counting tray, weigh balance, mortar & pestle, self adhesive labels, self-sealing packs for tablets/pills, running water, pedal waste bins, hand-wash basin, etc [Requirement on pharmaceutical business premises Prescription files and record books, ‘expired products record book, bin cards, records- keeping system (computer/receipt books), Controlled Drugs Register, Cabinet for keeping controlled products, Reference materials (BNF, ZNF, BPH, MARTINDALE, STANDARDS OF PHARMACEUTICAL PRACTICE, PhC, ZNF, MASA, HPA, N & PSA, DDA, ETC) [Procedure for registration of pharmaceutical business ® Acquire guidelines from ZAMRA on the requirements on a particular pharmaceutical business(Retail, wholesale or manufacturing) ® Complete an application form which should be endorsed by the full-time pharmacist and ‘the application form should also have the names of the proprietors of the business. «= Attach to the application form the following documents after which the application is submitted: [Procedure for registration of pharmaceutical business ‘= Certificate of Incorporation or Registration(PACRA) = Registration Certificate for pharmacist (HPCZ) «= Practicing Certificate for pharmacist and Pharmacy Technologist (HPCZ) » Employment Contract between pharmacist/Pharmacy Technologist and the Company or letter of agreement between the two parties | QUESTIONS +. Briefly describe the current ZAMRA structure and state the functions of each Department (20 Marks) 2 Outline the history of medicines and pharmacy regulation in Zambia a. Whatdo you understand by the term 4 (a) Alternative Medicine (b) ‘Complementary Medicine? Give examples of Alternative Medicines 's_ List and briefly describe the types of pharmaceutical businesses regulated by MRA eet| QUESTIONS = List and describe the Categories of medicinal products regulated by ZAMRA = Define the terms + Marketing Authorization ® Clinical Trial Post-Marketing Surveillance Activity + Pharmacovigilance + Pharmaceutical product Dossier ESTHER | QUESTIONS Marketing Authorization Number Over-The-Counter Medicine Adverse Drug Reaction + Alternative Medicine & give examples of these Complementary Medicine + Adulterated Medicine -refer to MASA Counterfeited Medicine-refer to MASA + Falsified Medicine (MASA) + Substandard medicine or allied substance PHIR | [QUESTIONS = List the major differences in terms of content between the Pharmaceutical Act No. 14 of 2004 and the MASA No. 3 of 2013 «= List the types of Licences issued by ZAMRA 1 List the types of Permits issued by ZAMRA. 1 List the types of Certificates issued by ZAMRA = List the Laws enforced by ZAMRA, DEC, HPCZ, ZABS, ZRA, ZEMA, CCPC, POLICE [QUESTION «= List 10 offences one could commit under MASA PROCESS OF REGISTRATION OF PHARMACEUTICAL BUSINESSES # Guidelines Retail & Wholesale Pharmaceutical business (REFER TO THE ZAMRA GUIDELINES) [CONAIENCENENT OF OPERATION OF RETA. PHARMACY