3rd Bpharm PP PRESENT-1.pptx Zmb pharmacy student

Pharmacy practice

1. 3rd Bpharm Phamacy practice presentation group 9 The Pharmaceutical Act was repealed and replaced with the MASA (Medicines and Allied Substances Act

2. OBJECTIVES To know the reasons for establishment of pharmaceutical act To the know reasons for the repeal of pharmaceutical act To establish the gaps [lacunas ]the pharmaceutical act that were enacted in MASA What recommendations were made based on the lacunas identified in pharmaceutical act. The impact of the changes enacted in the MASA have had in the pharmaceutical industry in pharmacy practice. To find recommendations in reference to the question.

3. Definations A lacuna refers to a gap or omission in law or legal system where no specific provision or regulation exits. An act refers to law or piece of legistration passed by legistrative board. Repeal refers to the act of revoking or abolishing a law or regulation. MASA (Medicines and Allied Substances Act]

4. Introduction An Act to establish the Pharmaceutical Regulatory Authority and to define its functions; to provide for the registration and regulation of pharmacies; to provide for the registration and regulation of medicines intended for human use and for animal use; to provide for the regulation and control of medicines, herbal medicines and allied substances; to provide for the regulation and control of the manufacture, importation, exportation, possession, storage, distribution, supply, promotion, sale and use of medicines, herbal medicines and allied substances; to repeal the Pharmacy and Poisons Act, 1940 and the Therapeutic Substances Act, 1968; and to provide for matters connected with or incidental to the foregoing. The 2004 Pharmaceutical Act was repealed and replaced with the MASA (Medicines and Allied Substances Act) in 2013

5. The Pharmaceutical Act was replaced by the Medicines and Allied Substances Act (MASA) to address gaps and lacunas in the previous legislation. The MASA continued the existence of the regulatory authority, renaming it as the Zambia Medicines Regulatory Authority. It expanded the scope of regulation to include allied substances, improved provisions for clinical trial regulation, and enhanced regulations for promotion, advertising, and sale of medicines. The replacement aimed to provide a more comprehensive and streamlined regulatory framework for the pharmaceutical industry in Zambia

6. The reasons for the establishment of the Pharmaceutical Act 1.To establish the Pharmaceutical Regulatory Authority and its function. . To provide for the registration and regulation of : pharmacies; medicines intended for human use and for animal use To provide regulation and control of : manufacture , importation, exportation, possession, storage, distribution, supply, promotion, sale and use of medicines, herbal medicines and allied substances Medicines , herbal medicines and allied substances

7. CONTINUATION 2.To repeal the pharmacy and poison Act ,1940 and the therapeutic substances Act,1968 3.To provide for matters connected with or incidental to the foregoing

8. THE REASONS FOR THE REPEAL OF THE PHARMACEUTICAL ACT. To continue the existence of the Pharmaceutical Regulatory Authority and re-name it as the Zambia Medicines Regulatory Authority. To provide for the new functions and powers of the Authority such as; provide for the registration and regulation of pharmacies, health shops and agro - veterinary shops. provide for the regulation and control of clinical trials.

9. The gaps (lacunas) in the Pharmaceutical Act that were enacted in the MASA: The following are changes which were made: PART 2:(ZAMBIA MEDICINE REGULATORY AUTHORITY] ) Continuation and renaming of the authority The seal of authority was introduced Expert advisory committee was formed Immunity on action or other proceeding shall not lie or be instituted. PART 3:REGULATION AND REGISTRATION Surrender of certificate of registration Amendment of certificate of registration Dispensing certificate Health shop permit

10. CONTI PART 4:LICENSES IMPORT AND EXPORT Two more contents were added such as Additional requirements for import and export Register of license and permit PART 5:REGISTRATION OF MEDICINES AND ALLIED SUBSTANCES Four more contents were added such as Marketing authorization Recall of medicines Register of marketing authority Monitoring medicine and allied substances

11. CONTI, PART 6:REGULATION OF CLINICAL TRIALS Three more contents were added such as Inspection of clinical trial sites Register of clinical trial certificate Herbal medicines were removed PART 7:NATIONAL DRUG QUALITY CONTROL LABORATORY One content was added which the establishment of national drug quality control laboratory. PART 8:INSPECTIONS Inspectors were introduced Inspection had three contents in PA which where removed and where replaced by Inspectors in MASA

12. CONTI, PART 9:GENERAL PROVISIONS Eight more contents were added such as Appeal General offences Standard of cosmetics Repeal of ACT no 14 of 2004

13. Impact of changes enacted in the MASA on the pharmaceutical industry and pharmacy practice Enhanced patient safety Increased transparency and accountability. Strengthened regulatory oversight. Improved research environment . Improved accessibility of health care services through Health shops Brought up about education to local people thorough establishment of health shops.

14. Recommendations. Regular review and evaluation of the MASA to address emerging challenges and adapt to evolving regulatory needs in the pharmaceutical industry. Continuous capacity building and training for regulatory authorities, healthcare professionals, and stakeholders to ensure effective implementation of the MASA. Collaboration with international regulatory bodies and organizations to align regulations and practices with global standards, fostering international harmonization.

15. Conti; Active engagement with the pharmaceutical industry and pharmacy professionals to understand their needs, concerns, and perspectives, facilitating a collaborative and effective regulatory environment. Ongoing public awareness and education campaigns to promote understanding of the MASA, its regulations, and the importance of safe and rational use of medicines Enhanced patient safety by ensuring that all medicines and allied substances being made available to the people consistently meet the set standards safety and efficacy

16. Conclusion The enactment of the MASA (Medicines and Allied Substances Act) in Zambia brought some notable changes to the pharmaceutical industry and pharmacy practice. It replaced the outdated Pharmaceutical Act and aimed to establish a well-regulated framework for the registration, regulation, and control of medicines, allied substances, pharmacies, and other related establishments.

17. MEMBERS END OF PESENTATION THANK YOU FOR LISTENING

18. PARTICPANTS SN NAME OF STUDENT STUDENT NNUMBE 1 SIKASOTE JIMMY 230400642 2 ENED SAMBWA 230400366 3 YOGO ERNEST SIKAZWE 210400014 4 ISAAC SIKANYIKA 230400355 5 SILOMBA MASI 230400356 6 TEMBO LOVEMORE 210400145 7 CATHERINE SIMPWAL0 210400007 8 TOMAIDA SAKALA 210400337 9 MAIMBO SIMONGA 210400173 10 MUDUNDU SIALWINDI  210400034 11 12 JOY SIABANYAMA FRANCIS SANGUZA  210400571 210400100 12 MUBITA SIKUFELE  230400326