The Pharmacy Act

2. Short title and commencement. Interpretation. E s t a b l i s h m e n t o f t h e P h a r m a c y C o u n c i l PART II

13. Establishment o f the Pharmacy Council. Functions o f the Council. Powers o f the Council. Pharmacy Committee and its composition. Disciplinary Committee and its composition. Establishment o f other committees. Meetings o f other committees. Funds and resources o f the Council. Remuneration o f the members o f the Council. Registrar and his responsibilities. Secretariat. PART III R e g i s t r a t i o n , E n r o l m e n t a n d L i s t i n g o f P h a r m a c e u t i c a l P e r s o n n e l

3 .-(l) There is hereby established a council to be known as the Pharmacy Council. (2) The Council shall be a body corporate and shall— Cap 134 Functions o f the Council (a) (b) (c) (d) have perpetual succession and an official seal; in its corporate name be capable o f holding, purchasing or otherwise acquiring in any other way any movable or immovable property and disposing o f any o f its property; subject to the provisions o f the Government Loans, Guarantees and Grants Act, have power to borrow such sums as it may require for its purpose; and in its corporate name, be capable o f suing or being sued. (3) The Schedule to this Act shall govern the appointment o f m em bers to the Council, constitution, procedures and other matters relating to the Council. (4) The Minister may, upon advice o f the Council and by order published in the Gazette, amend, vary or replace all or any o f the provisions o f the Schedule to this Act.

4. The Council shall be the sole authority for registering, o f Pharmacists, enrolling Pharmaceutical Technicians and Pharmaceutical Assistants respectively, and shall, in addition, perform the following functions- listing and 9 No. 1 The Pharmacy Act, 2011 2011 (a) (b) (c) (d) to the and relating promote provision the Minister on matters advise pharmacy practice; o f safeguard pharmaceutical services in compliance with norms and values, in both public and private sectors, therapeutic with goals o f achieving definite outcomes for the health and quality o f life o f a client; uphold and safeguard the acceptable standards o f in both public and private pharmacy practice sectors; establish, acceptable standards- (i) education, training and develop, maintain in pharmaceutical continuing professional development; control and (ii) ' for the registration o f a person who provides one or more or all o f the services which part o f the scope o f practice o f form the category such a person is registered; in the practice o f the various categories o f persons required to be registered under in which (iii) this Act; and (iv) o f professional conduct required for persons to be registered under this Act; (e) enquire into any query practice raised by the public; relating to a pharmacy (i) (h) (g) interest in, and advancement o f the (f) maintain and enhance the dignity o f the pharmacy profession and the integrity o f a person practicing the profession; regulate standards and practices o f the pharmacy profession; promote pharmacy profession; in collaboration with the Tanzania Commission for Universities and the National Accreditation evaluate Council for Technical Education, for academic Pharmacists, Pharmaceutical Technicians and Pharmaceutical Assistants for the purpose o f registration, enrolment or enlisting under this Act; foster cooperation between the Council and other the institutions or organizations, dealing with qualifications practical and (j) 10 (k) (1) The Pharmacy Act, 2011 2011 pharmacy profession; ensure proper collection of fees payable under this Act; keep and maintain registers, Rolls and Lists for the Pharmacists, Pharmaceutical Pharmacists; registration, enrollment and enlisting o f Technicians, Intern Pharmaceutical Assistants and (m) administer the accounts and assets o f the Council (n) (o) (p) (q) (r) (s) (t) or any assets to be held in trust for the benefit o f the Council; prescribe the scope o f practice o f the persons registered, enrolled and enlisted under this Act; regulate activities o f Pharmacists, Pharmaceutical Technicians and Pharmaceutical Assistants ; ensure that training in pharmacy at any institution in Tanzania guarantees the necessary knowledge and skills needed for the efficient pharmacy practice; pay any member o f the Council, committee, staff or any person entrusted with any task under this Act, such allowance as it may determine; determine the fees payable to the Council services performed by the Council Act; promote rational use o f medicines; and under this for carry out such other conferred upon the Council by any other written law. functions as may be The Council shall have powers t o - (a) appoint any officer or inspector to perform any (b) duty or act on behalf o f the Council; prescribe and determine powers and duties o f officers and inspectors appointed pursuant to paragraph (a); (c) remove any name from the Register, Roll or List subject to such conditions as the Council may impose; (d) consider any matter affecting the pharmacy profession, and take such action in connection therewith as the Council may consider necessary; 11 No. 1 The Pharmacy Act, 2011 2011 (e) (f) (g) (h) powers to any officer, delegate any o f inspector or organization; require any person its registered, the Council with enrolled or enlisted under this Act or involved in pharmacy practice or offering pharmaceutical education or training the furnish to information it requires; inquire into any matter, complaint, charge or allegation o f improper or disgraceful conduct against any person registered, enrolled, enlisted or any other person or premises registered under this Act which is brought to the attention o f Council; and approval o f Institution and curriculum for the training o f pharmacy education. Pharm acy C om m ittee and its com position D isciplinary C om m ittee and its com position

15. Examination and qualifications. Registers o f Pharmacists. No. 1 The Pharmacy Act, 2011 2011

33. Qualification for registration as Pharmacist. Internship training. Provisional registration. Tem porary Registration. Certificate o f registration. Restriction on use o f title. Application for retention in the Register. Roll o f Pharmaceutical Technicians. Enrolment o f Pharmaceutical Technicians. Certificate o f enrolment. Application for retention in the Roll. List o f Pharmaceutical Assistants. Enlisting o f Pharmaceutical Assistants. Certificate o f enlisting. Application for retention in the List. Publication o f registered, enrolled and enlisted persons. Registrar m ay call for information. Publication as sufficient evidence o f registration, enrolment or listing. PART IV R e g i s t r a t i o n o f P r e m i s e s A n d I s s u a n c e o f P e r m i t f o r B u s i n e s s i n M e d i c i n e s

14.-(1) The Council shall conduct professional examination for registration, enrolment or enlistment o f candidates as Pharmacists, Pharmaceutical Technicians or Pharmaceutical 15 No. 1 The Pharmacy Act, 2011 2011 R egisters o f Pharm acists Assistants. (2) If an applicant is registered, enrolled or enlisted under this Act he shall, upon payment o f the prescribed fees, be entitled to practice as a Pharmacist, Pharmaceutical Technician or Pharmaceutical Assistant.

15.-(1) The Registrar shall keep registers o f Pharmacists in the prescribed forms. (2) The Registrar shall, as soon as practicable and after the Council has accepted any person for registration, enter in the respective register in respect o f the person, the following particulars- (a) (b) (c) (d) his name and address; the date o f registration; his qualifications and status o f his registration; and such other particulars as the Council may direct. (3) All changes in the particulars registered under subsection (2) shall be entered in the register by the Registrar. (4) The Registrar may rectify, save for any substantive error, any clerical or typographical error in the registers or other docum ent containing extract from the registers. Q ualification for registration as Pharm acist

16.-(1) A person shall not be entitled to provide services as a Pharmacist, unless he is duly registered under this Act. (2) A person shall be entitled, upon making an application to the Council in the prescribed manner, to be registered as a Pharmacist under this section and offer his services if he satisfies the Council th a t- (a) he holds a pharmacy degree or any other qualification recognised by the Council as being equivalent to a pharmacy degree; (b) he has complied with additional requirements relating to the acquisition o f practical experience as a pharmacist; and such (c) his professional and general conduct render him fit and proper person to be registered as Pharmacist. Internship training

17.-(1) A Pharmacist shall not be registered unless the Council is satisfied that he has undergone internship training for a period o f one year. 16 No. 1 The Pharmacy Act, 2011 2011 Provisional registration (2) The Council may extend the period for internship for a further period o f up to two years. A person who is not entitled to be registered by reason only o f the fact that he has not complied with the additional requirements referred to in section 16 (2) (b) shall, if, upon application in the prescribed manner, he satisfies the Council that he has secured an offer for employment or training in an institution or facility approved by the Council for the purposes o f complying with the additional requirements, be entitled to be provisionally registered for a duration provided under the regulation made under this Act. (2) A person who is provisionally registered shall be deemed to be registered as far as is necessary to enable him to be employed for the purpose stated in subsection (1) o f this section in such institution or facility approved by the Council the certificate o f provisional as registration. shall be specified in (3) The Registrar shall maintain a separate register in which he shall enter the particulars o f those persons provisionally registered. T em porary registration

19.-( 1) Where a person satisfies the Council that- (a) (b) (c) (d) he is not ordinarily resident in Tanzania; he is or intends to be employed in Tanzania for the express purpose o f carrying out a specific assignment in research or teaching ; he is or immediately before entering Tanzania was practicing as a Pharmacist and that he is eligible for registration under section 16 o f this Act; and his professional and general conduct renders him fit and proper to be registered, the Council may direct that he be registered under this section for the duration o f the specific assignment or for the period which the Council may specify, in either case the period shall not exceed twelve months. (2) The Council shall require any person applying for registration under this section to appear before the Pharmacy to his to produce documents Com mittee and assignment or employment. relating (3) Registration o f a person under this section shall 17 No. 1 The Pharmacy Act, 2011 2011 C ertificate o f registration R estriction on use o f title continue only while he is engaged on the specific assignment or for the period specified by the Council and on his ceasing to be so engaged or on expiration o f the period, his registration shall Cease to have effect. (4) In case o f doubt as to the cessation o f engagem ent o f a person mentioned under subsection (3) on the specific assignment or as to the expiry o f the period specified by the Council. (5) Notwithstanding sub-section (4) a person aggrieved by the decision o f the Council may appeal to the Minister.

20. The Registrar shall, upon the registration o f a Pharmacist and on payment o f the prescribed fee, issue a certificate o f registration in the prescribed form.

21.-(1) A person other than a Pharmacist shall not, on or after the com m encem ent o f this Act, assume, take, exhibit or in any way make use o f any title, emblem or description which suggest that he is a Pharmacist. (2) A person who contravenes the provisions o f this section shall be guilty o f an offence and upon conviction shall be liable to a fine o f not less than one million shillings or to imprisonment for a term not exceeding two years or to both. (3) For the purpose o f subsection (1), the use o f any o f the titles “ pharmacist”, “druggist”, “pharmaceutist” , “apothecary” , “ apothek”, or “pharmaceutical chemist” or any similar word or combination o f words in any language, shall be.d eem ed to suggest that the person is or persons are pharmacists. A pplication for retention in the R egister 2 2 .-(l) Every registered person shall, before the 31st D ecem ber o f each year, file information to the Council in the prescribed manner for the retention o f his name in the register. (2) An under accompanied by a prescribed fee. application subsection (1) shall be (3) The Council may remove from the relevant register any registered person who does not comply with the provisions o f subsections (1) and (2). Roil o f Pharm aceutical T echnicians 2 3 .-(l) The Registrar shall keep a Roll o f Pharmaceutical Technicians in the prescribed forms. (2) As soon as practicable and after the Council has accepted any person for enrolment, the Registrar shall enter in - 18 No. 1 The Pharmacy Act, 2011 2011 the Roll in respect o f that person the following particulars- (a) his name and address; (b) the date o f enrolment; (c) his qualifications; and (d) such other particulars as the Council may, from time to time direct. (3) All changes o f the particulars o f person enrolled under subsection (2) shall be entered in the Roll by the Registrar. (4) The Registrar may rectify, save for any substantive error, the Roll or other any clerical or typographical error documents containing extract from the Roll. in E nrolm ent o f Pharm aceutical T echnicians 2 4 .-(l) A person shall be entitled, upon making an application to the Council in the prescribed manner, to be enrolled under this section and to offer his services if he satisfies the Council that- (a) he is a Pharmaceutical Technician who is a holder o f a diploma in pharmaceutical sciences or any other qualification recognized by the Council as being equivalent to a diploma in Pharmaceutical sciences offered in Tanzania; (b) he has complied with such additional requirements relating to the acquisition o f practical experience as a Pharmaceutical Technician, as the Minister may, after consultation with the Council, prescribe by regulations made under this Act; and (c) his professional and general conduct render him a fit and proper person to be enrolled. (2) An applicant aggrieved by the decision o f the Council under this section may appeal to the Minister within thirty days after receipt o f the decision.

25. Upon enrolment o f a Pharmaceutical Technician and on paym ent o f the prescribed fee, the Registrar shall issue a certificate o f enrolment in the prescribed form. 2 6 . - 0 ) Every enrolled person shall, before the 31sl Decem ber o f each year, file information to the Council in the prescribed manner for the retention o f his name in the Roll. (2) An application under subsection (1) shall be accompanied by a prescribed fee. (3) The Council may remove from the Roll any enrolled person who does not comply with the provisions o f subsections (1) and (2) o f this section. 19 C ertificate o f enrolm ent A pplication for retention in the Roll No. 1 List o f Pharmaceutical Assistants The Pharmacy Act, 2011 2011 2 7 .-(l) The Registrar shall keep a List o f Pharmaceutical Assistants in the prescribed form. (2) As soon as practicable after the Council has accepted any for enlisting, the Registrar shall enter in the List in person respect o f that person the following particulars- (a) his name and address; (b) the date o f enlisting; (c) his qualifications; and (d) such other particulars as the Council may direct. (3) All changes in the particulars enlisted under subsection (2) shall be entered in the List by the Registrar. (4) The Registrar may rectify, save for any substantive error, the List or other any clerical or in documents containing extract from the List. typographical error Enlisting o f Pharmaceutical Assistants 2 8 .-(l) A person shall not be entitled to provide service as a Pharmaceutical Assistant unless he is duly enlisted under this Act. (2) A person shall be entitled, upon making an application to the Council in the prescribed manner, to be enlisted under this section and to offer his services if he satisfies the Council that— (a) (b) he holds a certificate in pharmaceutical sciences or any other qualification recognized by the Council as being equivalent to a certificate in pharmaceutical sciences; additional he has the acquisition of requirements Pharmaceutical a practical Assistant, as the Minister may, after consultation with the Council, prescribe by regulations made under this Act; relating experience complied with to as such (c) his professional and general conduct render him fit and proper to be enlisted.

29. Upon the enlisting o f a Pharmaceutical Assistant and on payment o f the prescribed fee, the Registrar shall certificate o f enlisting in the prescribed form. issue a 3 0 .-(l) Every enlisted person shall, before the 31s1 Decem ber o f each year, file information to the Council in the prescribed m anner for the retention o f his name in the List. Certificate o f enlisting Application for retention in the List 20 No. 1 The Pharmacy Act, 2011 2011 Publication o f registered, enrolled and enlisted persons Registrar may call for information Publication as sufficient evidence o f registration, enrolment or listing (2) An application under subsection (1) shall be accompanied by the prescribed fee. (3) The Council may remove from the List any enlisted person who does not comply with the provisions o f subsections (1) and (2).

31.-(1) The Registrar shall, by notice, cause to be published in the Gazette, as soon as may be practicable after registering, enrolling or enlisting the particulars entered in the Register, Roll or List in respect o f each person and subject to the direction o f the Council, any amendment or deletion o f the particulars in the Register, Roll or List. (2) The Registrar shall, by notice, cause to be published in the Register, Roll or Gazette, at least once r ach year, the particulars entered in the List in respect o f all persons remaining on the Register, Roll or List at close o f the previous year.

32. The Registrar shall, on his own motion or if requested by the Council, and if he considers it necessary for the furtherance o f the objectives and purposes o f this Act, require any person registered, enrolled or enlisted under this Act, by a registered letter submitted to the last known address o f the person, to furnish any information relating to his practice as a Pharmacist, Pharmaceutical Technician or Pharmaceutical Assistant or any other matter which may be specified in the letter. 3 3 .-(l) A publication under section 31 shall be sufficient evidence that the person mentioned in it is registered, enrolled or enlisted under this Act, and the deletion from the Register, Roll or List o f the name o f any person notified by the publication, or the absence o f the name o f any person from that publication, shall be sufficient evidence that, that person is not registered, enrolled or enlisted or that the validity o f his registration, enrolment or enlisting has ceased to have effect. (2) The Registers, Rolls and Lists and their copies or extracts from them which purport to have been certified under the hand o f the Registrar shall be received in a court, tribunal or any body authorized to receive as sufficient evidence o f the facts stated therein. 21 No. 1_________________________ The Pharmacy Act, 2011 2011 PART IV R e g i s t r a t i o n o f P r e m i s e s a n d I s s u a n c e o f P e r m i t f o r B u s i n e s s i n M e d i c i n e s Registration o f prem ises

46. Registration o f premises. Change o f business ownership or any other change. Application for permits. Types o f permits and revocation, suspension and cancellation o f permits. Pharmacy practices. Rational use o f medicines. Minister m ay allow a permit to be issued. Exception when supplying and dispensing medicines. Council to issue dispensing certificates. Restriction on pharmacy business and use o f title. Conditions for body corporate to become authorized seller o f medicine and pharmaceutical products. PART V G e n e r a l P r o v i s i o n s Penalties for professional misconduct. Restriction on promotion and advertisement of medicines, medical devices or herbal medicines. No. 1 The Pharmacy Act, 2011 2011

34. -(1) A person shall not sell, dispense or supply medicinal products except in premises registered under this Act. (2) An application for registration or renewal o f registration o f premises shall be made to the Council in the prescribed form, and shall be accompanied by such fee as the Council may prescribe. (3) The Registrar or any person in his behalf shall- (a) keep a register o f all premises registered under this section; (b) register premises if he the requirements to be complied with by the applicant as prescribed by the Council from time to time have been complied with; or satisfied that is (c) have powers to approve the location and name o f the proposed premises. (4) The Council may, for good cause, refuse to register or cause to be removed from the register, any premises which is or has become unsuitable for purposes for which they were registered. (5) A person who contravenes the provisions o f subsection (1) commits an offence and upon conviction shall be liable to a fine not exceeding ten million shillings or imprisonment for a term not exceeding two years or to both. 3 5 .-(l) Every business owner shall, in writing notify the Council in the case o f any change o f ownership o f the business or the change o f registered premises. (2) Subject to subsection (1), the registration o f premises under this Act shall cease to have effect upon expiration o f thirty days from the date o f changing the ownership o f the business o f medicines and related medical supplies. C hanges o f business ow nership or any other change A pplication for perm its 3 6 - ( l) A person shall not sell, dispense or supply medicinal products unless he has obtained a permit issued under this Act. (2) An application for a permit shall be made to the Council 22 No. 1 The Pharmacy Act, 2011 2011 in the prescribed form, and shall be accompanied by such fee as the Minister may prescribe. (3) The Council shall not issue a permit to sell medicines and related medical supplies under this section unless the Council is satisfied- (a) (b) (c) (d) the premises in respect o f which that the application relates shall be stored, meets the prescribed standards; that the equipment are available for storing medicines and related medical supplies; and with the suitability o f the equipment facilities which are used for distributing the medicines and related medical supplies; and the with the arrangements made or to be made for securing the safe keeping, and the maintenance o f adequate records in respect o f medicines and related medical supplies stored in or distributed from those premises. Types o f permits and revocation, suspension and cancellation o f permits (4) A separate permit under this section shall be required in respect o f each set o f premises in which the business is carried on. 3 7 .-(l) The Registrar shall, subject to sub section (2) and upon an application made to, and on approval by the Council, issue the following pharmacy permits for- (a) retail; (b) distribution; (c) (d) any other business as the Council may deem fit for institutional; or the purpose o f this Act. (2) Where the Council is satisfied that the applicant is a fit and proper person to carry on type o f business set out in subsection (1) and the premises in which the business is to be conducted meets the prescribed standards, it shall, issue a permit appropriate to such business subject to such general or special conditions as to be appropriate to impose. the Council may consider (3) A permit issued under subsection (1) shall be in the form and m anner as set out in the regulations made under this Act. (4) Where the Council considers that the applicant is not fit and proper person to be issued with a permit to carry on any 23 No. 1 The Pharmacy Act, 2011 2011 business specified under this section it shall refuse to issue the permit, as the case may be. (5) The Council may, subject to the provisions o f this Act and upon satisfaction that the terms and conditions o f issuance o f permit have been violated- (a) (b) revoke, suspend or cancel the permit, as the case may be; and direct the Registrar- (i) to notify the person whose permit has been (ii) revoked, suspended or cancelled; and to delete the name o f the person whose permit has been revoked, suspended or cancelled, as the case may be. Pharm acy practice

38. The Council shall, for the purposes o f pharmacy practice, prescribe- (a) the scope o f practice o f persons registered, enrolled or enlisted under this Act or the services or acts which shall, for purposes o f this Act, be deemed to be services or acts pertaining to the pharmacy profession and the conditions under which the services may be provided; the services the various categories o f pharmacies, and the conditions under which the services shall be provided; rules relating to- to be provided in (i) Code o f Conduct for Pharmacists, and Pharmaceutical Technicians Assistants Pharmaceutical registered, enlisted under this Act; enrolled or (ii) Good Pharmacy Practice; (iii) the services for which a Pharmacist may levy fees and guidelines for levying such fees; titles or the pharmacy may be conducted; and trading names under which a (b) (c) (d) (e) matters relating to the investigation inspection o f the pharmacy practice and conduct o f the business o f a pharmacist. and the 24 No. 1 Rational use o f m edicines The Pharmacy Act, 2011 2011 3 9 .-(l) The Council shall, for purposes o f rational use o f medicines, prescribe roles o f pharmaceutical personnel relating to- (a) pharmaceutical care; (b) accessibility, sustainability, affordability, efficacy, safety and quality o f medicines; relating (c) self medications; (d) policy perspective changes; (e) pharmaceutical public health; (f) research and communication; and (g) any other act medicines. the purposes o f ensuring the rational use o f medicines, no person shall sell by retail or in circumstances corresponding to retail sale or administer other than to himself, a medicine product o f a description or a class specified by order made by the Minister and published in the Gazette, except in accordance with a prescription made by an appropriate practitioner. to appropriate use o f supply For (2) (3) In this section “appropriate practitioner” means a medical practitioner, dentist, veterinarian, or any other person as the Minister, may by Order published in the Gazette, specify. (4) A person who contravenes the provisions o f subsection (2) com m its an offence and on conviction shall be liable to a fine not exceeding five million or to imprisonment for term not exceeding twelve months or to both. N'.mister m ay i-!ow a perm it : be issued the Minister may, notwithstanding any o f 4 0 .-(l) Where public interest require and upon advice by the Council, the provisions o f this Act relating to dispensing o f medicines by order published in the Gazette, allow any persons or group o f person to dispense such medicines as may be specified. to be permitted by the Council (2) The Minister may, in addition to any other conditions, require an applicant qualifications or training, as the case may be. for a permit to possess specified I ception en supplying -* _ dispensing ~< cicines

41.-(1) A medical practitioner, dentist or veterinary surgeon or a m em ber o f the staff o f a hospital, health centre, dispensary or similar institution who has been authorized to do so by the general or special order o f the Minister, on the advise o f the Council, may supply or dispense a prescription medicine for 25 No. 1 The Pharmacy Act, 2011 2011 the purpose o f medical, dental or veterinary treatment as the case may be, subject to the following conditions: (a) (b) the medicine shall be distinctly labeled with the name and address o f the person by whom it is supplied or dispensed; the following particulars shall, within twenty four hours after the medicine has been supplied or dispensed, be entered in a book used regularly for the purpose, and which shall be called the Prescription Book- (i) (ii) (iii) (iv) (v) dispensed; the quantity the medicine was the date on which supplied or the name, strength and supplied; the name and address o f the person to whom the medicine was supplied; the name and address o f the person by whom the prescription was made; and name and address o f a prescriber or prescribing health facility. (2) Where an authorized seller o f medicines supplies a prescription medicines a shall enter Prescription Book kept in accordance with the provisions o f this section. its particulars in (3) A ny person to whom subsection (1) applies and who supplies or dispenses any prescription medicine in a m anner contrary this section, commits an offence and upon conviction is liable to a fine o f not more than one million shillings or to imprisonment, for term not exceeding six months or to both. to . Council to issue dispensing certificates 4 2 .-(l) The Council may, if it is in the public interest and upon an application and subject to such conditions as may be prescribed, issue a dispensing certificate to a practicing medical practitioner or dentist or veterinary surgeon to dispense medicines. (2) Upon application to the Council pursuant to subsection (1), the Council may issue a dispensing certificate subject to such conditions as it may deem necessary. (3) The Council may, if it is satisfied that the applicant did not or is not fulfilling any condition given, may suspend, revoke or withdraw the dispensing certificate issued under 2(5 No. 1 The Pharmacy Act, 2011 2011 subsection (1). Restriction on pharm acy business and use o f title 4 3 .-(l) A person shall not carry the business o f pharmacist unless that person is a pharmacist or is in association with a pharmacist. (2) No person other than a Pharmacist shall manufacture for the sell, supply or dispense any medicine except under immediate supervision o f a Pharmacist. (3) A permit to practice and a certificate o f registration o f a be business shall o f having Pharmacist the conspicuously exhibited in the premises. (4) Where the body is an association- control Cap 208 and 222 (a) a copy o f the certificate o f its registration under the Business Name the Companies Act or any other charter or instrument establishing such association, shall be lodged with the Council; (Registration) Act or (b) the business shall be under the management o f the Pharmacist in charge who shall be a Pharmacist; (c) in each set o f premises for the retail sale o f medicines, the business shall be headed by the Pharmacist in-charge. “druggist”, “ pharmacist”, (5) For the purpose o f subsection (3), the use o f any o f the titles chemist” , “pharmaceutist” or “drug chemist” or a similar word or combination o f words in any language, shall be deemed to suggest the owner o f the business or the person having control o f the business on such a premises is a Pharmacist. “dispensing (6) Nothing in this section shall apply to emergency supply o f m edicine for use within twenty four hours to a particular person for a treatment by a qualified medical practitioner, a dentist for the purpose o f medical, veterinary surgeons for veterinary treatment. (7) Any person who contravenes section, commits an offence and conviction- the provisions o f this liable upon shall be (a) in case such person is an individual, to a fine o f not less than one million shillings or to imprisonment for a term not less than six months or to both; (b) in case such a person is an association, firm or body corporate, to a fine o f not less than five million shillings. 27 No. 1 Conditions for body corporate to become authorized seller o f medicine and pharmaceutical products The Pharmacy Act, 2011 2011 4 4 .-(l) Any body corporate carrying on business involving sale o f drugs shall be an authorized seller o f medicines within the m eaning o f this Act, if- (a) with regard to the keeping, selling, dispensing is under the and com pounding o f medicines the business managem ent o f a superintendent who- is a Pharmacist; (i) (ii) has signed and submitted to the Registrar a statement in writing on behalf o f the body corporate stating his name and specifying whether or not he is a m em ber o f that body; and that is not at capacity for any other body; time acting in similar (iii) (a) (b) to his directions under is carried on either under in each set o f premises for the sell o f medicines, the business the personal supervision o f the superintendent or subject the personal control o f another Pharmacist; the name and certificate o f registration o f the superintendent or o f some other Pharmacist having control o f the business is conspicuously exhibited in the premises. (2) Where- (a) (c) a body corporate which is an authorized seller o f drugs has been convicted of an offence under this Act; or any member o f the body corporate or any o f its officer or any officer employed by it in carrying the business, has been convicted o f any on criminal guilty o f or has misconduct which, in the opinion o f the Council, renders him or would, if he were a Pharmacist, render him unfit the register, the Council may inquire into the matter and may, subject to this Act, direct that- to be on offence, been (i) the body corporate cease to be an authorized seller o f medicines, and be disqualified for a period to be specified in the directions from seller o f 28 an authorized being No. 1 The Pharmacy Act, 2011 2011 medicines; or (ii) any or all o f the premises o f medicines and the body corporate be removed from the register o f premises and be disqualified for such period as the Council may direct. (3) The Council may, either on its own motion or on application by cessation o f any disqualification imposed under this Act. the body corporate concerned, direct the PART V G e n e r a l P r o v i s i o n s P e n a lt i e s fo r p r o f e s s i o n a l m i s c o n d u c t 4 5 .-(l) Where- (a) a registered, enrolled or enlisted person is found by the Council to be guilty o f professional misconduct; a registered, enrolled or enlisted person is convicted in Tanzania or elsewhere for an by any court is offence which, in the opinion o f the Council the status o f a Pharmacist, incompatible with Pharmaceutical Technician Pharmaceutical Assistant; or the name o f any such person has been fraudulently registered, enrolled or listed, or (b) (c) the Council shall direct the Registrar to - (i) cancel, suspend or remove his name from the Register, Roll or List; (ii) impose any other penalty depending on the nature and the gravity o f the professional misconduct committed by such person. (2) The Council may, defer further its decision as to the giving o f a direction under the provisions o f subsection (1 )(c) until subsequent meeting o f the Council, but- (a) (b) no decision shall be deferred under this subsection for a period exceeding one year in the aggregate; and no person shall be a member o f the Council for the purposes o f reaching a decision which has been deferred or further deferred unless he was present as a member o f the Council when the decision was deferred. ; 29 No. 1 The Pharmacy Act, 2011 2011 (3) For the purposes o f subsection (1), a person shall not be treated as guilty as mentioned under paragraph (b) o f subsection (1) unless the conviction stands at a time when no appeal or further appeal is pending or may be brought in connection with that conviction. (4) Where the Council gives a direction under subsection (1), the Council shall cause a notice o f the direction to be served on the person to whom it relates. (5) A direction o f the Council under subsection (1) shall take effect- (a) where no appeal under this section is brought against (b) the direction; or where an appeal is brought and is subsequently withdrawn or struck out for want o f prosecution. (6) A person whose name is removed from a Register, Roll or List pursuant to a direction o f the Council under this section shall not be entitled to be registered in that register, Roll or List again except in pursuance o f a direction in that behalf given by the Council on the application o f that person. Restriction on promotion and advertise­ ment o f medicines, medical devices or herbal medicines 4 6 .-(l) A person shall not promote and advertise medicines, medical devices or herbal medicines in a manner that is false, misleading, deceptive or to create erroneous impression regarding its character, value, quantity, composition, merit, safety or efficacy, as the case may be. likely that is (2) A person shall not carry out any promotional activities on medicines, medical devices or herbal medicines in relation to pharmacy practice without a written approval o f the Council. (3) A person shall not advertise or sell by retail any medicines, medical devices or herbal medicines in connection with any bonus, offer or discount. (4) Notwithstanding the provisions o f subsections (1), (2) and (3), an advertisement shall not include the following: (c) words forming part o f a sound recording or in a sound-track associated with a embodied cinematograph film; (d) words broadcast by way o f sound broadcasting or to a transmitted to subscribers television or diffusion service; and anything spoken in public. (e) 30 No. 1 The Pharmacy Act, 2011 2011 (5) A ny person who contravenes the provisions o f this section com m its an offence and shall, upon conviction be liable, where such person is- (a) an individual, to a fine o f not less than two million shillings and not more than ten million shillings or to imprisonment for a term o f not less than six months but not more than three years or to both; or a body corporate or an association, to a fine o f not less than five million shillings but not more than fifteen million shillings. (b) -.rpoint- o f supervisory officers J m c e lla - i o n or ; ^spension of :ertificates Procedure for cancellation or suspension

60. Appointm ent o f supervisory officers. Cancellation or suspension o f certificates. Procedure for cancellation or suspension. Reinstatement to the Register etc. Appeals. Inspection. Offences and penalties. Liability o f members o f the Council etc. Regulations. Rules. Repeal and savings. PART VI C O N S E Q U E N T I A L A M E N D M E N T S Construction. Am endm ent o f section 21. Repeals. S C H E D U L E 3 ■ No. 1 The Pharmacy Act, 2011 2011 T H E U N I T E D R E P U B L I C O F T A N Z A N I A NO. 1 O F 2011 I A S S E N T , J a k a y a M . K i k w e t e , P resid en t 3 rd J u n e , 2011 An Act to establish the Pharm acy Council and to provide for the functions, m anagem ent of the Council; to provide for regulation and control of the pharm acy profession and practice and to provide for other related matters. E n a c t e d by Parliament o f the United Republic o f Tanzania. P A R T I P r e l i m i n a r y P r o v i s i o n s title

47 .-(l) The Minister may, after consultation with the Council and by notice published in the Gazette, appoint such registered, enrolled or enlisted persons to be supervisory officers at the district and regional levels. (2) A person appointed in accordance with subsection (1) shall perform supervisory functions o f pharmacy practice and any other functions as the Council may direct. 4 8 .-(l) The Council may, subject to section 50 and if it is satisfied that the terms and conditions o f registration, enrolment or enlisting have been violated- (a) (b) cancel or suspend the certificate; and direct the Registrar- (i) (ii) to notify the person whose certificate has been cancelled or suspended; and to remove the name o f the person whose certificate has been cancelled from the Register, the Roll or the List. A person aggrieved by decision o f the Council under sub­ (2) section (1) may appeal to the Minister within a period o f seven days. 4 9 .-(l) Where a registered, enrolled or enlisted person is in violation o f the terms and conditions o f his registration, enrolment or enlisting, the Registrar shall, on the direction o f the Council, serve to that person a notice in writing specifying the nature o f default. (2) Upon receipt o f the notice under subsection (1), the person to whom the notice is served shall make representation in writing to the Registrar on the rectification o f the default. 31 No. 1 The Pharmacy Act, 2011 2011 (3) Where the person under subsection (2) fails to rectify the default within the time specified in the notice or fails to make representation satisfactory to the Registrar, the Registrar shall recommend to the Council for cancellation or suspension o f the certificate issued to that person. (4) The Council shall, if it is satisfied with the recommendations made under subsection (3), direct the Registrar to cancel or suspend the Certificate o f Registration, Certificate o f Enrolment or Certificate o f Enlisting for a period as the Council may consider appropriate: (5) A cancellation or suspension o f a certificate made under subsection (4) shall not exceed a period o f twelve months. 5 0 .-(l) A person whose certificate has been cancelled or suspended shall be required to apply for reinstatement o f his registration, enrolment or enlisting. (2) An applicant for reinstatement may make an application within two years o f cancellation or suspension otherwise such applicant shall be required to apply afresh as if he had never been registered. (3) The Council may appoint a senior pharmaceutical personnel to monitor a person who has been suspended, cancelled or removed the Register, Roll or List and such senior pharmaceutical personnel may be required by the Council to make a report or any recommendation to the Council. from

51.-(1) A person who is aggrieved by any decision o f the Council under this Act, may, at any time within thirty days after receiving the notice o f decision o f the Council appeal to the Minister. (2) Any appeal against the decision o f the Minister shall lay to the High Court. 5 2 .-(l) The Council may, the purpose o f ensuring compliance with the provisions o f this Act, conduct or cause to be conducted inspection in any premises or pharmacy. for (2) The Minister shall, upon advice o f the Council, make regulations prescribing for- (a) appointment or designation, powers and qualifications o f inspectors; and (b) conducting o f inspections for the purpose o f this Act. 5 3 .-(l) Unless otherwise exempted under this Act, a Pharmacist who uses a licence in respect o f which fees are in 52 Reinstate­ ment to the Register etc. Appeals Inspection Offences and penalties No. 1 The Pharmacy Act, 2011 2011 arreas for more than one year- (a) for or in expectation o f reward practices or holds him self out as a Pharmacist; or (b) without reasonable excuse takes or uses any name, implying that he is title, addition or description authorised by law to practice as a pharmacist; for the purpose o f procuring the registration o f any name, qualification or other matter; (c) indemnity i t iability (i) (ii) makes a statement which he believes to be false in a material particular; or recklessly makes a statement which is false in a material particular, commits an offence.

54. N othing done by any member o f the Council, the Registrar or any other person empowered to perform any function under this Act shall, if done in good faith in execution or purported execution o f his functions under this Act, render the member, the Registrar or that other person authorised to perform functions under this Act personally liable for the matter or things done.

55. The Minister may, upon advice of the Council, make regulations with respect o f any o f the following matters or for any o f the following purposes- (a) (b) (c) (d) (e) (f) (g) (h) or in which additional suspension cancellation the m anner requirements relating to practical experience referred to in section 16, 24 or 28 may be conducted; the conduct o f inquiry by the Council, and the attendance o f witnesses and production o f evidence at the inquiry under this Act, including the power to take evidence on oath; o f for grounds registration, enrolment or enlisting granted under this Act; disciplinary Pharmaceutical Technicians and Assistants; the pharmacy practice; the conduct o f business o f a pharmacy, including the premises, medicines and related medical supplies; any fees payable under this Act; the conditions o f services o f staff appointed by the Council; Pharmacists, Pharmaceutical procedures for 33 No. 1 The Pharmacy Act, 2011 2011 (i) (j) (k) (1) (m) (n) (o) (p) (q) (r) other qualifications training, education or Technicians and enlisting Pharmaceutical Technician Pharmaceutical Technicians registration o f Pharmacists, enrolment o f o f the information to be furnished to the Registrar by Pharmacists, and Pharmaceutical Assistants who are owners or managers o f pharmacies carrying on business as Pharmacists; the minimum requirements o f the curricula and the duration o f the course o f study for a basic degree, diploma, certificate in Pharmacy or any other certificate to be issued under this Act; the Pharmaceutical Pharmaceutical Assistants by the Council; the required for registration, enrolment or enlistment o f or Pharmacist, Pharmaceutical Assistant; the required as Pharmaceutical as conditions under Pharmaceutical Assistants and which such persons shall be required to be so enrolled or enlisted; supplementary training or refresher courses to be undertaken by any person registered, enrolled or enlisted under this Act, and control thereof; prescribing supervisory officers; promotion and advertisement o f medicines, medical devices and herbal medicines; specialties in respect of which registered persons may apply for registration; and anything which prescribed under this Act. functions, conduct and powers o f to Technicians is required or permitted enrolled enlisted persons be or to be R u l e s 5 6 .-(l) The Council may, with approval o f the Minister, make rules for the better carrying out o f its functions under this Act and, without prejudice to the generality o f the power conferred by this section, the Council may by such rules- (a) (b) (c) prescribe qualifications which shall be recognized as entitling the holder to registration, enrolment or enlisting under this Act; prescribe ethics for the practice o f the profession o f pharmacy; prescribe standards o f professional conduct o f 34 No. 1 The Pharmacy Act, 2011 2011 (d) (e) pharmacists; provide for and regulate the m anner o f giving assistance to members o f the public on matters touching upon, ancillary or the incidental practice o f the profession o f pharmacy; and prescribe anything which, in the opinion o f the the Council performance o f its functions or the exercise o f its powers under this Act. incidental ancillary or to to is Repeal and savings Cap. 311 C a p . 2 1 9 C onstru­ ction Cap. 219 A m end- (2) Rules made by the Council under this section shall be published in the Gazette.

57 .-(l) The Pharmacy Act is hereby repealed. (2) Notwithstanding the repeal under subsection (1 ) - (a) (b) (c) before immediately person who, every the com m encem ent o f this Act, was registered in the Register o f Pharmacists under the repealed Act, and is resident in Tanzania, shall be deemed to have been registered under this Act; and any premises registered or business o f pharmacist permitted under the repealed provisions o f the Tanzania Food, Drugs and Cosmetics Act, shall be deemed to have been done under the provisions of this Act; any subsidiary legislation made or directives issued under the repealed Act, shall be deemed to have been done under the provisions o f this Act. (3) Every person deemed by subsection (1) to be registered under this Act shall within twelve months after the date o f coming into operation o f this Act, be required to submit to the Council particulars o f his registration in such form as shall be prescribed and be in accordance with the provisions o f this Act. issued with a certificate o f registration prepared PART VI C O N S E Q U E N T IA L A M E N D M E N T S

1. This Act may be cited as the Pharmacy Act, 2011 and shall come into operation on such date as the Minister may, by notice in the Gazette, appoint. -relatio n

2. In this Act, unless the context otherwise requires- ' ‘advertisement” means communication, whether a publication or by the display o f any notice or by means o f any catalogue, price list, letter, as a circular or addressed to a particular person, or by the exhibition o f a photograph or a cinematograph film, or by way o f sound recording, sound broadcasting, or television or any other means or communication; in “authorized seller o f medicines” means a person, other than a person lawfully authorized to conduct a retail pharmacy business who may sell pharmaceutical products pursuant to section 44; 5 No. 1 The Pharmacy Act, 2011 2011 “ business o f a pharmacy” includes professional pharmacy practice and any activity carried on by a person in relation to medicines, medical devicc or herbal medicines; “ certificate” means a certificate issued by the Council under this act; “ certificate o f enrolment” means the certificate issued to a Pharmaceutical Technician under section 25; “ certificate o f enlisting” means the certificate issued to Pharmaceutical Assistant under section 29; “ certificate o f registration” means the certificate issued to a Pharmacist under section 16; “ co m m ittee” means any committee established under section 8; “ C ouncil” means the Council established under section 3; “dispense” means the supply o f medicines or medicine products in accordance with the prescription lawfully given by a medical practitioner; “distribution” means a business o f dealing in human medicines or medical devices in bulk or wholesale but does not include importers o f human medicines, medical devices, food, cosmetics and veterinary medicines; “distributor” means a person who buys medicines or medical devices from importers or local manufacturers and who sells includes importers; in bulk or wholesale to retailers, and “ h e rb a l m e d i c i n e ” m e a n s any lab elled p r e p a ra tio n in a p h a r m a c e u tic a l activ e in g re d ie n t an d on e o r m o re s u b s ta n c e s o f n atu ra l o rig in th at are d e riv e d from plants; c o n tain d o s a g e th at an “ i n s p e c t o r ” m e a n s an in s p e c to r a p p o in ted , a u th o riz e d o r r e c o g n iz e d as su c h u n d e r this Act; “ In tern P h a r m a c i s t ” m e a n s any p e rso n re g is te re d as s u c h u n d e r se c tio n 17; “ label” means any tag, brand, mark, pictorial or other descriptive matter, written, printed, stenciled, marked, embossed or impressed on or attached to a container o f medicines, medical devices or herbal medicines; “ List” means a List o f Pharmaceutical Assistants maintained under section 27; “ medicine or pharmaceutical products” means any substance or mixture o f substances manufactured for treatment o f diseases or for use in the diagnosis or prevention o f 6 No. 1 The Pharmacy Act, 2011 2011 diseases, disorders or abnormal physical or mental state or the symptoms thereof, in man or animal; reagent or other similar or “ medical device” means an instrument, apparatus, implement, medical equipment, machine, contrivance, implant, in- vitro related articles, including any component, part or accessory which is - recognized in the Official National Form; (a) (b) uiar Pharmacopoeia or any o f their supplement; (c) intended for use in diagnosis o f diseases or other conditions, or in cure, mitigation, treatment or prevention o f disease in man or animal; or Cap 152 (d) intended to affect the structure, any function o f the body o f man or animal and which does not achieve any o f its principal intended purposes through chemical action within such body o f man or animal and which is not dependent upon being its metabolized principals intended purposes; for achievement o f any o f “ medical practitioner” means a person who is registered as the Medical Practitioners and practitioner under Dentists Act; “ m em b er” means a person appointed to be a member o f the includes the Chairman and Pharmacy Council and Vice-Chairman; “ M inister” means the Minister for the time being responsible for matters relating to health services; any “ pharm acy” means any approved premises wherein or from to practice o f a service pertaining which pharmacist is provided, and shall include a community pharmacy, institutional pharmacy, or wholesale pharmacy; pharmacy, consultant 7 No. 1 The Pharmacy Act, 2011 2011 “ pharmacy practice” means any acts pertaining to the scope o f practice o f a pharmacist, pharmaceutical technician or pharmaceutical assistant as approved by the Council; “ pharm acist” means a person registered under section 16; “ Pharmaceutical Technician” means a person enrolled under section 24; “ Pharmaceutical Assistant” means a persons enlisted under section 28; “ prem ises” includes a land, building, structure, basements and a vessel and in relation to any building includes a part o f a building any cartilage, forecourt or yard, and in relation to a vessel includes a ship, boat, air craft, and a carriage or receptacle o f any kind, whether open or closed or place o f storage used in connection with any service pertaining to practice o f a pharmacist; “prescription” means a lawfully written direction by a medical practitioner or veterinary doctor for the preparation and dispensation o f a medicine by a Pharmacist; “ prescription medicine” means any medicine product required to be dispensed only upon a prescription given by medical practitioner, veterinary surgeon or any other person approved by the Minister; “ professional misconduct” means any conduct which in breach o f the Code of Conduct prescribed under this Act done, by a person who is registered, enrolled or enlisted under this Act; is “provisional certificate” means a certificate issued under section 18; “ Register” means a Register maintained under this Act; “ Registrar” means the Registrar of the Council appointed under section 12; “retail pharmacy business” includes the retail sale o f medicines products but does not include a professional practice carried by a medical practitioner or veterinarian; “ Roll” means a Roll maintained under section 23 o f this Act; “ superintendent” means supervises a pharmacy and Council under this Act; a Pharmacist In-Charge who is registered as such by the “ supervisory officer” means a person appointed under section 47 to be a supervisory officer over pharmacy practice; “ unfit to practice” means incapability, incompetency or unsuitability to- No. 1 The Pharmacy Act, 2011 2011 C ap.319 (a) continue to be registered, enrolled or enlisted in terms o f the Act; or (b) perform acts forming part o f the scope o f practice o f his category o f registration, enrollment or enlistment as a result o f a physical or mental condition; “veterinarian” means a person registered under the Veterinary Act; “ wholesale pharmacy” means a pharmacy that buys medicines, medical devices or cosmetics from importers and sell in bulk to retail pharmacy; “ wholesaler” means a person who buys medicine, medical local devices importers manufacturers and sells in bulk to the retailer. cosmetics from or or E s t a b l i s h m e n t o f t h e P h a r m a c y C o u n c i l PART II Establishment o f the Pharmacy Council

58. This Part shall be read as one with the Tanzania Food, Drugs and Cosmetics Act hereinafter referred to as the principal Act.

59. The principal Act is amended in s e c tio n a l by- 35 No. 1 m cnt o f section 21 The Pharmacy Act, 2011 2011 (a) deleting subsection (1) and substituting for it the following: “(1) The Authority shall, subject to subsection (2) and upon application, issue the following licences or permits: (a) manufacturing licence; (b) wholesale licence; (c) retail licence in food, cosmetics and veterinary medicines and veterinary devices; (d) any other licence and permit as the Authority may deem fit for the purposes o f this Act. (2) The word “wholesale licence” as used in subsection (1) (b) means a licence for dealing in wholesale food, cosmetics or veterinary medicines, and includes importation o f human medicines and medical devices. the business relating to in (b) renumbering subsection (2) to (4) as subsection (3) to (5) R epeals

60. The principal Act is amended by repealing section 24, 26, 27, 47, 48 and 74. SCHEDULE (Made under section 3(3)) C om po­ sition o f the C ouncil l . - ( l ) The Council shall consist of the following members appointed by the Minister: (a) a Chairman appointed from amongst persons registered as pharmacists from private sector, have contributed towards the promotion and development of the pharmacy practice; (b) the Chief Pharmacist from the Ministry of Health and Social Welfare; (c) representative Tanzania; from the Pharmaceutical Society of (d) a Principal from a public higher learning institution that 36 No. 1 The Pharmacy Act, 2011 2011 o f f e r s t r a i n i n g in p h a r m a c y ; ( e ) a r e p r e s e n t a t i v e o f t h e A t t o r n e y G e n e r a l ; (f) o n e e n r o l l e d o r e n l i s t e d P h a r m a c e u t i c a l T e c h n i c i a n s r e c o m m e n d e d f r o m t h e T a n z a n i a P h a r m a c e u t i c a l T e c h n i c i a n s A s s o c i a t i o n ; a n d ( g ) o n e p e r s o n f r o m t h e p u b l i c w h o s e q u a l i f i c a t i o n s a n d e x p e r i e n c e c a n a s s i s t t h e C o u n c i l a n d t h e d e v e l o p m e n t o f t h e p h a r m a c y p r o f e s s i o n . ( 2 ) . T h e C o u n c i l m a y c o - o p t a n y p e r s o n to a tt e n d its m e e t i n g s b u t t h e p e r s o n s h a l l n o t h a v e a r i g h t to v o t e Vice Chairman

6 .-(l) There shall be established a committee to be known as the Pharmacy Committee whose functions shall be to prescribe and evaluate qualifications for registration, enrolment and enlisting and evaluate application for premises registration under this Act and making recommendations to the Council. (2) The Pharmacy Committee shall consist o f a Chairman to be appointed from amongst members o f the Council and four other m em bers to be appointed by the Council.

7 .-(l) There shall be a committee to be known as the Disciplinary Committee whose function shall be to conduct preliminary investigation into any case where it is alleged that a registered, enrolled or enlisted person has misbehaved in his capacity as a Pharmacist, Pharmaceutical Technician, or Pharmaceutical Assistant, or should for any reason be the subject o f proceeding before the Council. (2) The Disciplinary Committee shall consist o f a Chairman to be appointed from amongst members o f the Council and four other m embers to be appointed by the Council. (3) The procedure for conducting an inquiry under this Act shall be prescribed in the regulations. (4) The Council may, in connection with the complaint, from any person, charge or allegation, seek including the person against whom the complaint, charge or allegation has been lodged. information (5) In the case o f a complaint, charge or allegation which forms or is likely to form a criminal case, the Council shall 12 No. 1 The Pharmacy Act, 2011 2011 adjourn the holding o f the inquiry until such case has been concluded by the court o f competent jurisdiction. E stablishm ent o f other com m ittees

8 .-(l) The Council may establish a number o f other committees to carry out any special or general functions determined by the Council and may delegate to any such com m ittee such the Council may consider necessary. functions as M eetings o f com m ittees (2) Each committee may co-opt as a member o f such committee any person who is not,a member o f the Council and any o f such members so co-opted may or may not be an officer in the public service.

9 .-(l) A Chairman o f a committee shall convene a meeting o f the committee o f which he is the Chairman. (2) The Council may, at any time, direct a Chairman o f any com m ittee to convene a meeting o f his committee and such Chairman shall, as soon as practicable, comply with such directions. (3) Each committee shall keep minutes o f its meetings, inform the Council o f its activities and conduct its proceedings in such m anner as the Council may direct. Funds and resources o f the C ouncil

10.-(1) The funds and resources o f the Council shall consist o f - (a) (b) (c) (d) (d) such sums as may be appropriated by Parliament for the purpose o f the Council; all fees payable under this Act; such donations, grants, bequeaths, and loans as the Council may, from time to time, or organization; proceeds derived from sale o f C ouncil’s properties; and any other source o f income identified by the Council and legally obtained. receive person from any 13 No. 1 The Pharmacy Act, 2011 2011 (2) The funds and resources o f the Council shall be applied for the purposes for which the Council in accordance with the directions o f the Council. is established and (3) The Council shall keep proper accounts and other records relating to the funds and resources. (4) The Council shall— (a) (b) establish one or more separate accounts in a credible commercial bank into which all monies received by the Council shall be paid in and out; prepare estimates expenditure and adhere to any such estimates; ensure that the operations o f the Council are exercised in an economical and efficient manner; (d) manage the resources o f the Council in a prudent income annual and (c) o f manner; (e) prepare and publish an annual report which shall include- (i) an account o f the operations o f the Council during the year covered by the report; (ii) a set o f audited accounts; (iii) such other matters as may be prescribed; (f) to the Council appoint such full-time and part-time staff as seems to be appropriate and necessary to ensure that the matters referred to it in this section are implemented; (g) take all such other action which shall advance the objects and purposes o f the Council. (5) Where the Minister is o f the opinion that the Council is not carrying out its functions in a proper and reputable manner, he shall give it such directives in writing to ensure that it is carrying out its functions as specified. (6) The accounts o f the Council shall be audited on an annual basis by the Controller and Auditor-General or by a firm o f auditors certified by the Controller and Auditor-General. (7) The Council shall, not later than six months after the end o f the financial year, submit to the Minister a copy o f audited accounts and annual report and activities o f the Council in 14 No. 1 The Pharmacy Act, 2011 2011 respect o f that year. (8) The Minister shall, within the period o f six months after the accounts have been audited, lay the audited accounts and audit report before the National Assembly. R em uneration o f the m em bers o f the Council

11.-(l) M embers o f the Council and the Secretariat shall be paid from the funds o f the Council such allowances as the Council may determine with the approval o f the Minister. (2) In determining the allowances, the Council shall make in provision for reimbursement o f any expenses connection with the business o f the Council. incurred R egistrar and his responsibilities

12.-( 1) The Minister shall appoint a registered Senior Pharmacist in the public service to be the Registrar o f the Council. (2) The Registrar shall be the Secretary to the Council. (3) Subject to provisions o f this Act, the Registrar shall be and the administration the Council for responsible m anagem ent o f its affairs. to Secretariat (4) There shall be a Deputy Registrar appointed by the Minister, who shall assist the Registrar in his day to day activities and, on such other functions as may be prescribed by the Council. (5) Subject to subsection (3), in the absence o f the Deputy Registrar, any other officer o f the Council shall carry out the functions o f the Registrar in his behalf as the Chairman o f the Council may, in writing, designate.

13.-(1) There shall be a Secretariat o f the Council which shall consist o f the Registrar, Deputy Registrar and such num ber o f officers or staff as the Council may determine. (2) The officers and staff o f the Council shall be the Governm ent employees for the performance o f the functions o f the Council. (3) The officer and staff o f the Council shall be paid remuneration or allowances on such terms as the Council may determine, subject to approval o f the Minister. PART III R e g i s t r a t i o n , E n r o l m e n t a n d E n l i s t i n g o f P h a r m a c e u t i c a l P e r s o n n e l Exam ination and qualifications

2. T h e m e m b e r s s h a l l e l e c t o n e o f t h e i r n u m b e r s t o b e t h e V i c e - C h a i r m a n o f t h e C o u n c i l a n d a n y m e m b e r e le c t e d a s V i c e - C h a i r m a n s h a l l, s u b j e c t t o h i s c o n t i n u i n g to b e a m e m b e r , h o l d o f f i c e fo r a t e r m o f o n e y e a r f r o m t h e d a t e o f h is e l e c t i o n , b u t sh a ll b e e li g i b l e f o r re - e l e c t i o n . Tenure o f office

3 . - ( l ) A m e m b e r s h a l l, u n l e s s h i s a p p o i n t m e n t is t e r m i n a t e d b y t h e M i n i s t e r , o r h e c e a s e s in a n y o t h e r w a y to b e a m e m b e r , h o l d o f f i c e f o r a p e r i o d o f t h r e e y e a r s a n d sh a l l b e e li g i b l e f o r r e a p p o i n t m e n t . ( 2 ) M e m b e r s a p p o i n t e d b y v i r tu e o f t h e i r o f f i c e sh a l l c e a s e t o be m e m b e r s u p o n c e a s i n g to h o l d t h e o f f i c e e n ti t l i n g a p p o i n t m e n t t o t h e C o u n c i l . ( 3 ) A m e m b e r o f t h e C o u n c i l sh a ll c e a s e to b e a m e m b e r if- ( a ) t h e M i n i s t e r , in t h e p u b l i c in te re s t, t e r m i n a t e s h is m e m b e r s h i p a f t e r g i v i n g w r i t t e n n o t i c e to t h e m e m b e r t o s h o w c a u s e w h y h i s m e m b e r s h i p s h o u l d n o t b e t e r m i n a t e d ; ( b ) ( c ) c e a s e s t o h o l d t h e p o s i t i o n e n ti t le d h is a p p o i n t m e n t ; h e fa ils w i t h o u t g o o d c a u s e to a tt e n d t h r e e c o n s e c u t i v e m e e t i n g s o f t h e C o u n c i l ; ( d ) h e is c o n v i c t e d o f a c r i m i n a l o f f e n c e f o r a t e r m o f o r b e y o n d s i x m o n t h s ; h e b e c o m e s m e n t a l l y ill; o r h e is d i s q u a l i f i e d to p r a c t i c e u n d e r th is A c t. ( e ) (0 Meetings o f the Council

4 . - ( l ) T h e C o u n c i l s h a l l o r d i n a r i l y m e e t at s u c h t i m e s a n d p l a c e s a s it d e e m s n e c e s s a r y f o r t r a n s a c t i o n o f its b u s i n e s s , b u t sh a l l m e e t a t le a s t o n c e in e v e r y t h r e e m o n t h s . ( 2 ) T h e C h a i r m a n o r in h i s a b s e n c e , t h e V i c e - C h a i r m a n , m a y at a n y t i m e c all a s p e c i a l m e e t i n g u p o n a w r i t te n r e q u e s t b y a m a j o r i t y o f th e m e m b e r s . ( 3 ) T h e C h a i r m a n , o r in his a b s e n c e t h e V i c e C h a i r m a n , sh a ll p r e s i d e a t e v e r y m e e t i n g o f t h e C o u n c i l a n d in th e a b s e n c e o f b o t h , t h e C h a i r m a n a n d V i c e C h a i r m a n , t h e m e m b e r s p r e s e n t sh a ll a p p o i n t a m e m b e r f r o m a m o n g s t t h e m s e l v e s to p r e s i d e o v e r th e m e e t i n g . Absent members

5. I f a m e m b e r o f t h e C o u n c i l w h o is a m e m b e r b y v i r tu e o f his 37 No. 1 The Pharmacy Act, 2011 2011 to be represented o f f i c e is u n a b l e f o r a n y r e a s o n to a tt e n d a n y m e e t i n g o f t h e C o u n c i l he m a y n o m i n a t e a n o t h e r p e r s o n f r o m his o r g a n i z a t i o n to r e p r e s e n t h i m in t h e m e e t i n g . Q uorum

6. T h e q u o r u m a t a n y m e e t i n g o f th e C o u n c i l s h a l l b e h a l f o f th e m e m b e r s . Votes

7 . - ( l ) S u b j e c t t o s u b - p a r a g r a p h (2 ) , m a t t e r s p r o p o s e d a t a m e e t i n g o f Decision o f the Council t h e C o u n c i l s h a l l b e d e c i d e d b y a m a j o r i t y o f t h e v o t e s o f t h e m e m b e r s p r e s e n t a n d v o t i n g a n d in t h e e v e n t o f a n e q u a l i t y o f v o t e s , t h e p e r s o n p r e s i d i n g s h a l l h a v e a c a s t i n g v o t e in a d d i t i o n to his d e l i b e r a t i v e v o te . ( 2 ) A d e c i s i o n m a y b e m a d e b y t h e C o u n c i l w i t h o u t a m e e t i n g b y c i r c u l a t i o n o f t h e r e l e v a n t p a p e r s a m o n g t h e m e m b e r s a n d the e x p r e s s i o n o f t h e v i e w s o f t h e m e m b e r s in w r i t i n g b u t a n y m e m b e r m a y r e q u i r e t h a t t h e d e c i s i o n b e d e f e r r e d a n d th e s u b j e c t m a t t e r b e c o n s i d e r e d a t a m e e t i n g o f t h e c o u n c i l . Minutes of meeting

8 . - ( l ) T h e C o u n c i l s h a l l c a u s e to b e r e c o r d e d a n d k e p t m i n u t e s o f all b u s i n e s s c o n d u c t e d o r t r a n s a c t e d a t th e m e e t i n g a n d t h e m i n u t e s o f e a c h m e e t i n g o f t h e C o u n c i l sh a ll b e r e a d a n d c o n f i r m e d o r a m e n d e d a n d c o n f i r m e d at t h e n e x t m e e t i n g o f th e C o u n c i l a n d s i g n e d b y t h e p e r s o n p r e s i d i n g a n d t h e S e c r e t a r y to t h e m e e t in g . ( 2 ) A n y m i n u t e s p u r p o r t i n g to b e s i g n e d b y th e p e r s o n p r e s i d i n g a n d t h e S e c r e t a r y a t a m e e t i n g o f th e C o u n c i l sh a ll in t h e a b s e n c e o f p r o o f o f e r r o r b e d e e m e d to b e a c o r r e c t r e c o r d o f t h e m e e t i n g w h o s e m i n u t e s t h e y p u r p o r t t o be.

9. T h e V a l i d i t y o f a n y A c t o r p r o c e e d i n g o f th e C o u n c i l sh a ll n o t b e a f f e c t e d b y a n y v a c a n c y a m o n g its m e m b e r s o r b y a n y d e f e c t in t h e a p p o i n t e d o f a n y o f t h e m .

10. S u b j e c t to t h e p r o v i s i o n s o f th is S c h e d u l e , th e C o u n c i l m a y r e g u l a t e its o w n p r o c e e d i n g s . 1 1 . A n y d o c u m e n t p u r p o r t i n g to b e u n d e r t h e h a n d o f t h e R e g i s t r a r as to a n y r e s o l u t i o n o f t h e C o u n c i l o r as h a v i n g b e e n is s u e d o n b e h a l f o f t h e C o u n c i l , s h a l l b e r e c e i v a b l e in all c o u r t s o r t r i b u n a l s o r o t h e r b o d i e s a u t h o r i s e d to r e c e i v e e v i d e n c e a n d sh a l l u n l e s s t h e c o n t r a r y is s h o w n , b e d e e m e d , w i t h o u t c o n t a i n e d in t h e d o c u m e n t . f u r t h e r p r o o f , to b e s u f f i c i e n t e v i d e n c e o f w h a t is Passed in the National Assembly on the 11th April, 2011. Vacancies etc, not to invalidate proceedings Council may regulate it own proceedings Proof o f docum ents D r . T h o m a s D . K a s h i l i l l a h , Clerk o f the National Assembly 38