FUNCTIONS OF THE BOARD - Pharmaceutical Export …pharmexcil.com/data/uploads/PresentationTSIV_4.pdf · Poisons Board REPUBLIC OF KENYA MINISTRY OF MEDICAL SERVICES PHARMACY AND POISONS

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Pharmacy and Poisons Board

REPUBLIC OF KENYA

MINISTRY OF MEDICAL SERVICESPHARMACY AND POISONS BOARD

Ensuring the provision of quality, safe and efficacious pharmaceutical products and services.

www.pharmacyboardkenya.org

FUNCTIONS OF THE BOARD


BACKGROUND

• The Pharmacy and Poisons Board was set up as a Regulatory Authority in1957 by an Act ofa Regulatory Authority in1957 by an Act of Parliament.

• It is a body corporate that is semi autonomous from its parent Ministry of Medical services.


• The Board regulates the Practice of Pharmacy, Manufacture and Trade in drugs and poisons.

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MISSION STATEMENT

The Board aims to implement appropriate regulatory measures to achieve the highest standards of safety, efficacy and quality for all medicines in Kenya.



MISSION OF THE BOARD

To regulate and control pharmaceutical services/practice in terms of safety, efficacy and quality of medicines.


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VISION OF THE BOARD

To improve and promote appropriate pharmaceutical care in Kenya.



PPB ORGANISATION STRUCTURE

MINISTRY OF MEDICAL SERVICESBOARD OF DIRECTORS

REGISTRARREGISTRAR

DEPUTY REGISTRAR

MEDICINEINFORMATION

DRUG REGISTRATION

PHARMACOVIGILENCE PHARMACEUTICALINSPECTORATE

LEGAL OFFICE

BOARD OF MANAGEMENT


TRAINING AND ASSESSMENT DEPT

GMP INSPECTORATE

IMPORT & EXPORT DEPARTMENT

National Quality Control Laboratory

LICENSING DEPARTMENT

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Functions of the Board

• To advice the Minister of Health on matters relating to Pharmacy and Poisons Act, CAP 244 laws Of Kenya.

• As stated in the functions of its Departments


.


DEPARTMENTS

• RESPECTIVE FUNCTIONS AS FOLLOWSFOLLOWS:


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Pharmaceutical Inspectorate

FunctionsE l ti f i f li f R t il• Evaluation for issuance of licenses for Retail, Wholesale premises and pharmaceutical manufacturers.

• Inspection of Medicine’s entry points.• Inspection of medicines distribution channels


• Issuing certificate of destruction for expired, counterfeit and substandard products.


Drug Registration

Functions• Receiving product applications, dossiers

and samples for registration.• Evaluation of dossiers and samples

submitted.Maintenance of products register


• Maintenance of products register.

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Pharmacy and Poisons BoardGood Manufacturing Practice (GMP)

Inspectorate

FunctionsE i f GMP li b ll• Ensuring of cGMP compliance byall pharmaceutical manufactures (locally and internationally)

• Regulation of trade of Precursors, narcotics and psychotropic substances.Q t l d l t f P


• Quarterly and annual returns of Precursors, Narcotics and Psychotropic substances to the International Narcotics and Control Board (INCB) in Vienna.


Trade Department

FunctionsE l ti d I f i t d t• Evaluation and Issuance of import and export permits for medicines and Pharmaceutical raw materials.

• Promote and maintain collaborative linkages with bodies to foster trade in Pharmaceuticals Li i i ith th Ph ti l I d t


• Liaising with the Pharmaceutical Industry on trade issues.

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Training and Assessment Department

FunctionsR l ti f h ti l t i i• Regulation of pharmaceutical training institutions.

• Evaluation for the Registration of Pharmacist and Pharmaceutical technologist.

• Issuance of Annual Practice license to Ph i t d Ph ti l T h l i t


Pharmacist and Pharmaceutical Technologist.• Issuance of Pharmaceutical Representatives

Permits.


Medicine Information

FunctionsE l ti f l f di i l• Evaluation for approval of medicinal advertisement

• Serving as medicines and Poisons information centre.

• Ensuring provision Rational use of Medicines


• Issuing health alerts and press release for public information.

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Pharmacy and Poisons BoardPharmacovigilance and Post Market

Surveillance Unit

FunctionsC ll b ti ith t k t ill f• Collaboration with post-market surveillance for Adverse Drug

Reaction (ADR).• Assessment and validation of completed ADR

case report forms.


• Maintaining contact with local/international on Pharmacovigilance.

• Coordinating clinical trial activities .

Pharmacy and Poisons BoardLegal Office

Functions:H dli L l iHandling Legal issues


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Support Departments

• Finance• Procurement.• ICT.


Documents

FUNCTIONS OF THE BOARD - Pharmaceutical Export …pharmexcil.com/data/uploads/PresentationTSIV_4.pdf · Poisons Board REPUBLIC OF KENYA MINISTRY OF MEDICAL SERVICES PHARMACY AND POISONS