1. The Health Institutions and Facilities Act 2011, (Act 829)
The Minister for Health submitted the Health Institutions and Facilities Bill (dated 23rd July 2010) to Parliament on 28 October 2010 for first reading of the Bill (13). The Ministry of Health and its agencies and stakeholders such as the Attorney’s General office (principal legal advisers) drafted the Bill.
‘The Health Institution and Facilities Bill was developed by the Ministry of Health and its agencies such as the Private Hospitals and Maternity Homes Board.’ (KI 6: 29/11/2018)
The part one of the Bill sought to provide for a Health Facilities Regulatory Agency to license facilities for the provision of public and private health care services. The Health Facilities Regulatory Agency was to replace and expand the mandate of the Private Hospitals and Maternity Homes Board under Act, 1958 (No.9) (14). The Private Hospitals and Maternity Homes Board (Act 1958) was outdated and did not adequately regulate all health care facilities.
‘The Private Hospital and Maternity Homes Board was over stretched and could not adequately regulate all private hospitals and maternity homes. The Act has not been revised since developed 1958 and a lot has happened since then within the health sector.’ (KI 4: 20/01/2019)
‘The Private Hospital and Maternity Homes Board’s objectives were outdated, and its regulation excluded other facilities such as eye care clinics, geriatric homes and diagnostic imaging technology clinic many of which were springing out in the country.’ (KI 6: 29/11/2018)
The Bill therefore sought to fill in the gap created by the Private Hospitals and Maternity Homes Board (1958) and mandate the Health Facilities Regulatory Agency to license the operation of these practices: ‘medical and dental services, clinics and hospitals, optometry and optician services, chiropody, convalescent and nursing homes, community health services, geriatric homes, nursing care, nursing agencies, maternity homes, occupational therapy services, physiotherapy services, dental laboratory technology services, clinical and bio-medical laboratory technology services, ophthalmic nursing services and physician assistants clinics’(14). After first reading of the Health Institutions and Facilities Bill, 2010 in Parliament, the speaker of Parliament in accordance to Article 106 of the Constitution of Ghana referred the Bill to the Parliament select Committee on Health for consideration (13).
Parliament Select Committee on Health deliberations
According to the 22nd March 2011, parliamentary debates report, the Committee on Health requested for written memoranda on the Bill from the general public and stakeholders to engage them in the decision-making process. The Committee met for three days with those who presented memoranda and other stakeholders in the health sector to examine the Bill in detail (15). The Committee reviewed the Bill and considered pharmacies as facilities to be licensed by the Health Facilities Regulatory Agency.
‘During the Committee’s consultative meetings there were discussions of adding pharmacies to list of facilities to be regulated by the Health Facilities Regulatory Agency.’ (KI 4: 21/01/2019).
‘The Pharmacy Council had successfully regulated pharmacies over the decades and agenda of the Bill was to replace the Private Hospital and Maternity Board policy and certainly not to take over the regulatory mandate of the Pharmacy Council’. (KI 2: 14/12/2018)
The stakeholders that met with the Committee to discuss the Health Institution and Facilities Bill are summarised in Table 2 (15). Of these stakeholders, a Pharmacy Interest Group of the PSGH - the Council of Elders, had concerns with the discussion to include pharmacies to the facilities to be licensed by the Health Facilities Regulatory Agency and therefore sent a memorandum dated 1 March 2011 to the Committee.
Table 2
Stakeholders that discussed the Health Institutions and Facilities Bill, 2010 with the Parliament Committee (15)
Minister for Health, Hon Joseph Yieleh Chireh
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Deputy Minister for Health, Hon Robert Joseph Mettle-Nunoo
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The Acting Chief Director Ministry of Health, Dr. Sylvester Anemana
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Chief Executives, Registrars and Directors of Agencies and Departments of the Ministry of Health
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Society of Private Medical and Dental Practitioners of Ghana
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Ghana National Chemical Sellers Association
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The Pharmacy Interest Group of the Pharmaceutical Society of Ghana (Council of Elders)
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Officials from the Attorney-General’s Department (The Legislative Drafter -principal legal adviser)
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In the memorandum, the Council of Elders made the following submissions in relation to the intended addition of pharmacies to the First Schedule of the Health Institutions and Facilities Bill. One, ‘ it is the practice in most part of the world for a separate and independent Authority to regulate both pharmacy practice including practitioners and licensing of pharmacy premises. This and the fact that under the existing legislation the Pharmacy Council is performing its mandate well and may have informed the decision to exclude pharmacies from the list of premises indicated in the Bill’. Two, ‘the Minister of Health’s memorandum to the Health Institution and Facilities Bill as published in the Gazette did not mention pharmacy at all’. Three, ‘currently the Pharmacy Council regulates about 12,000 registered facilities in Ghana made up of Pharmacy Retailers, Wholesalers, Retailers/Wholesalers and manufacturing wholesalers and 10,000 chemical sellers. In addition, Pharmacy Council inspectors pay working visits to public hospitals pharmacies and dispensaries.’ Four, ‘for effective and efficient inspection and monitoring of activities in these premises, the Pharmacy Council has set up offices throughout the country. Except for the northern part of Ghana (Northern, Upper East, Upper West) which has a zonal office at Tamale, the rest of the country has regional offices located in the capitals namely Accra, Kumasi, Sekondi, Cape Coast, Koforidua, Ho and Sunyani’.
Framing narratives and decisions relating to pharmacy premises regulation in Parliament
During the second reading of the Health Institutions and Facilities Bill, the chairman of the Parliament Select Committee on Health in his report to Parliament on the 22nd March 2011 noted that the Bill will expand the scope and mandate of the Private Hospital and Maternity Homes Board to regulate public health facilities as well as pharmacies. On the floor of Parliament, the Committee among other issues recommended adding ‘pharmacies and chemical shops’ to the definition of practice under Clause 24 of the Bill (16). But a parliamentarian was against the inclusion and noted that ‘the regulation and licensing of pharmacy practice is not bundled up with other healthcare practices in most parts of the world. For instance, the General Pharmaceutical Council in the United Kingdom and State Boards of Pharmacy and the General Pharmacy Council in Nigeria are all responsible for the license of pharmacies and related premises and regulation of pharmacy practitioners’. The parliamentarian further reiterated that the Pharmacy Council should be allowed to continue regulating pharmacies. The Minister for Health who is a parliamentarian supported this call to exclude pharmacies and the need to follow best practices around the world and allow the Pharmacy Council to continue its work. The Minister for Health noted that ‘pharmacies were left out by promoter of the Bill for good reasons’ and urged members to vote for the motion to exclude pharmacies. The speaker called for a vote on the motion. The question was put, and motion agreed to maintain a list that excludes pharmacies (16).
On the 23 June 2011, the Bill was discussed in Parliament during the consideration stage. Discussions focused on operationalising the activities of the Health Facilities Regulatory Agency and fine-tuning its functions. A member of the Parliament Select Committee on Health reiterated that ‘the Bill gives the Health Facilities Regulatory agency the mandate to determine locations of both public and private health facilities including where district hospitals should be located. In the similar logic, he argued that the agency should determine where pharmacies should be located since they are health facilities. The motion to amend the list of facilities to be regulated by the agency was made and the amendment agreed to (17).
‘Out of Parliament, the pharmacy fraternity were taken by a storm with the deliberations in Parliament to include pharmacies. This dramatic turnaround of events meant the advocacy and lobbying of the PSGH was not taken into account. Pharmacies were added to the list on the floor of Parliament’. (KI 2: 14/12/2019)
The Health Institutions and Facilities Bill was read the third time and passed on the 20 July 2011(18). The approved Health Institutions and Facilities Bill was gazetted on 31 December 2011 as Act 829 (6). The changes relating to pharmacy premises made to the Health Institutions and Facilities Act 829, 2011 are summarised in Table 3 (6, 14).
Table 3
Summary of provisions (text) modifications relating to pharmacy premises in Act 829 (6, 14)
Health Institutions and Facilities Bill, 2010
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Modified in Act 829
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Object and functions of the Agency: Clause 3 (1)
The object of the Agency is to license facilities for the provision of public and private health care services
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Object of the Agency: Clause 3.
The object of the Agency is to license and monitor facilities for the provision of public and private health care services
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Facilities to be licensed: Clause 10.(1)
A person shall not operate a private facility unless the facility is licensed under this Act
10.(2) ‘ A person shall not operate equipment for a service specified in the First Schedule unless the facility in which the person operates is licensed under this Act’
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Facilities to be licensed: Clause 11.(1)
‘A person shall not operate a facility unless the facility is licensed under this Act.
11.(2) ‘A person shall not operate equipment in a facility specified in the First Schedule unless the facility in which the person operates is licensed under this Act.
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Interpretation: Clause: 24
Practice includes medical and dental services, clinics and hospitals, optometry and optician services, chiropody, convalescent and nursing homes, community health services, geriatric homes, nursing care, nursing agencies, maternity homes, occupational therapy services, physiotherapy services, dental laboratory technology services, clinical and bio-medical laboratory technology services, ophthalmic nursing services and physician assistants clinics
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Interpretation: Clause 25.
Practice includes medical and dental services, clinics and hospitals, services in pharmacies and chemical shops, optometry and optician services, chiropody, convalescent and nursing homes, community health services, geriatric homes, nursing care, nursing agencies, maternity homes, occupational therapy services, physiotherapy services, dental laboratory technology services, clinical and bio-medical laboratory technology services, ophthalmic nursing services and physician assistants clinics
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First Schedule
The following facilities shall be licensed under this Act
a) Medical and dental (clinics and hospital)
b) Eye care clinics
c) convalescent and nursing homes
d) geriatric homes
e) maternity homes
f) occupational therapy clinics
g) physiotherapy clinics
h) dental technology laboratory
i) clinical and bio-medical laboratory
j) medical assistant clinics
k) diagnostic-imaging technology clinics
l) esteopathy clinics
m) prostherics and orthotics clinics
n) any other health care clinic or premised that may be determined by the Minister.
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First Schedule
The following facilities shall be licensed under this Act
a) Medical and dental (clinics and hospital)
b) Eye care clinics
c) convalescent and nursing homes
d) geriatric homes
e) maternity homes
f) occupational therapy clinics
g) physiotherapy clinics
h) dental technology laboratory
i) clinical and bio-medical laboratory
j) medical assistant clinics
k) diagnostic-imaging technology clinics
l) pharmacies and chemical shops
m) esteopathy clinics
n) prostherics and orthotics clinics
o) any other health care clinic or premised that may be determined by the Minister.
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2. Health Professions Regulatory Bodies Act, 2013 (Act 857)
The Ministry of Health drafted the Health Professions Regulatory Bodies Bill, 2010 in consultation with professional regulatory bodies and associations and the Attorney’s General office (principal legal advisers) to consolidate existing laws because they are similar in nature.
‘The Ministry of Health in 2010 started a process to consolidate all laws regulating health professions into one Act of Parliament’. (KI 5: 20/02/2019)
Although the Health Professions Regulatory Bodies Bill was dated 21 July 2010, same as the Health Institutions and Facilities Bill, it was submitted to Parliament on 4th March 2011 for first reading eight months later.
‘The Bills were drafted around the same time but passing the Health Institutions and Facilities Bill into law was a top priority since public health facilities and some private facilities were not regulated and the law regulating private hospitals and maternity homes was outdated.’ (KI 6: 29/11/2018)
The Health Professions Regulatory Bodies Bill, 2010 sought to establish Allied Health Professions Council, Medical and Dental Council, Nursing and Midwifery Council, Pharmacy Council and to provide for related purposes. Part four of the Bill expanded regulations under the existing Pharmacy Act 1994. The Bill establishes the Pharmacy Council and its functions included: ‘register practitioners and license premises in the public and private sectors’ (under clause 69c) and ‘monitor and inspect pharmacy premises and other premises where pharmaceutical care is provided’ (under clause 69e) (19). After the first reading in Parliament by the Minister for Health in 4th March 2011, the Bill was referred to the Parliament Select Committee on Health for consideration (20).
Parliament Select Committee on Health deliberations
According to the Committee’s report dated October 2012 requests were made for written memoranda on the Bill. The Committee’s had several meeting with stakeholders to examine the Bill in detail and these stakeholders are listed in Table 4 (20).
Table 4
Stakeholders that discussed the Health Professions Regulatory Bodies Bill with the Parliament Committee (20)
Deputy Minister for Health, Hon Robert Joseph Mettle-Nunoo
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The former Minister for Health, Hon Joseph Yieleh Chireh
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The Medical and Dental Council
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The Pharmacy Council
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The Nurses and Midwives Council
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The Allied Health Task Force
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The Ghana Health Service
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The Psychologists Associations of Ghana
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The Law and Development Associates
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Officials of the Ministry of Health
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Officials from the Attorney-General’s Department (The Legislative Drafter -Principal legal adviser)
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‘The Committee’s meetings with stakeholders were protracted because of the many conflicting issues raised by existing professional regulatory bodies and associations. Among others, were disagreements as to which practitioners constitute an allied health professional and the inclusion of a new entity, the Psychology Council. (KI 7: 28/11/2018)
The Committee proposed amendments to the Health Professions Regulatory Bodies Bill, 2010 and the amendments relating to pharmacy premises are listed in Table 5 (20).
Table 5
Proposed amendments by the Parliament Committee in relation to pharmacy premises (20)
Clause No. (Health Professions Regulatory Bodies Bill)
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Proposed Amendment
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Clause 69 (Functions of the Council)
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Paragraph (e) line 1 delete ‘ pharmacy premises and other practices’ and insert ‘ pharmacy practices and’
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Clause 83 (Licensing of premises)
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Delete
‘(1) A person shall not supply restricted medicines from premises unless the premises are licensed in accordance with this Part.
(2) A person who seeks to license premises for pharmacy practices shall apply to the Registrar in a manner determined by the Board
(3) The Board may revoke a licence if satisfied that the physical conditions of the premises have ceased to be suitable for the supply of restricted medicines
(4) A person who supplies restricted medicines from licensed premises shall notify the Board of material alterations in the structure of the premises within six months of the alteration
(5) The licence for premises may be general or limited and is valid for the period determined by the Board
(6) A general licence shall be issued for the supply of all classes of medicines and a limited licence shall be issued for the supply of medicines other than prescription only medicines and pharmacy only medicines.’
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Clause 97
(Entry of premises)
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Paragraph (a) line 2 delete ‘the licence of premises’ and insert pharmaceutical company
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Clause 99
(Power of closure)
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Sub-clause(1) line 3 delete ‘ or where the premises are unlicensed’
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Framing narratives and decisions relating to pharmacy premises and business regulation in Parliament
On the 24 October 2012, the Deputy Minister for Health moved for the Health Professions Regulatory Bodies Bill, 2010 to be read a second time in Parliament (21). The chair of the Committee on Health supported the motion and presented the committee’s report to Parliament. Proposed amendment related to licensing of Pharmacy premises presented to Parliament were as follows: One, ‘delete pharmacy premises from Sect. 69 and replace with pharmacy practice’. Two, ‘delete the whole Sect. 83 – licensing of premises’. Three, ‘under entry of premise section delete the licence of premises and replace with pharmaceutical company’. Four, ‘under power of closure section delete where the premises are unlicensed’ (21).
‘Clearly the Committee on Health sought to remove any provisions relating to licensing of pharmacy premise from the Health Professions Regulatory Bodies Bill.’ (KI:4 21/01/2019)
The Health Professions Regulatory Bodies Bill, 2011 was put forward for consideration on the 25 October 2012 (22) and 18 December 2012 (23) and on both days no reference was made to pharmacy premises and business regulation as other parts for the Bill were discussed. However, on 20 December 2012, during the consideration stage, the chair of the Committee on Health stated that the Pharmacy Council no longer regulates pharmacy premises because of the Health Institutions and Facilities Act passed in July 2011. Therefore, the Health Professions Regulatory Bodies Bill, 2011 must be amended to avoid a conflict of who is the legitimate regulator. To this a member of Parliament responded and noted that amending the Bill was important for future interpretation of the Act should any issue arise in the courts (24).
The chair of the Committee on Health moved for clause 77 titled ‘supervision of pharmacy’ be deleted. Clause 77 states that ‘A person shall not open or permit any other person to open premises to the public under the description of ‘pharmacy’, ‘dispensary’, ‘chemist’, ‘drug store’ or any other similar description unless a registered pharmacist is on the premises to supervise the dispensing of the medicines or medication’. He noted that clause 77 would create confusion and contradiction since the Pharmacy Council will not regulate premises. This motion was contested by a parliamentarian who argued that clause 77 does not entrust the Pharmacy Council with power to license but the clause is a prohibitive provision to make room for creating an offence. In a rebuttal, the immediate past Minister for Health and a parliamentarian, informed the House that the whole clause has been moved to clause 100 (titled offences) where it becomes a subclause. A motion was therefore passed for the amended order to stand as part of the Bill (24).
The following changes were also agreed to by parliamentarians. One, the deletion of clause 83 (licensing of premises); two, amendment to clause 84 (licensing of corporate bodies) and three, amendment to clause 97 (entry of premises). However, a request to delete the text –‘where the premises are unlicensed’- from clause 99 (power of closure) was contested and not agreed by Parliament. Clause 99 (1) states that ‘An inspector may close premises that sell or supply restricted medicines where there are grounds to believe that a health hazard may exist on the premises or where the premises are unlicensed’. The immediate Minister for Health opposed and stated the Pharmacy Council can inspect licence of pharmacy premises issued by a different authority and that the Council will not demand facilities obtain licence from them (24).
The Health Professions Regulatory Bodies Bill 2011 went through two consideration stages on the 21 December 2012 and pharmacy premises and business were not discussed (25, 26). The Bill was read a third time and passed on 21 December 2012 (26). The Pharmacy Act 1994 (Act 489) (5) was repealed and replaced by part four of the Health Professions regulatory bodies Act, 2013 (Act 857) (1). Table 6 (1, 19) summarizes the main contents modified and maintained in the Health Professions Regulatory Bill, 2010 in relation to pharmacy premises and the business of mixing, compounding, preparing, or supplying restricted medicines by retail. Figure 1 illustrates the decision-making processes and venues for Act 829 and Act 857. Figure 1 titled summary of decision-making processes and venues for Act 829 and Act 857.
Table 6
Summary of provisions (text) relating to pharmacy premises and business of retail in Act 857 (2013) (7, 19)
Health Professions Regulatory Bodies Bill, 2010 provisions modified or deleted in the Act 857
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Provisions of the Health Professions Regulatory Bodies Bill, 2010 maintained in the Act 857
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Provisions excluded in Bill, 2010 but included in Act 857
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Functions of the Council: Clause 69
(c) ‘register practitioners and licence premises in the public and private sectors’
modified to
Functions of the Council: Clause 80
(c) ‘register practitioners’
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Functions of the Council: Clause 69 (Bill) and Clause 80 (Act 857)
‘(d) ensure the equitable and accessible distribution of pharmaceutical premises’
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License for wholesale supply of restricted medicines: Clause 95
(1) ‘A person shall not carry on the business of the wholesale supply of restricted medicines unless that person has a licence for the wholesale supply of restricted medicines.’
(2) ‘The Board may grant a licence for the wholesale supply of restricted medicines subject to conditions which may prohibit or limit the supply of restricted medicines of a particular description.’
(3) ‘A promotional or marketing office where a person intends to engage in the wholesale pharmacy business shall be licensed and supervised by a registered pharmacist’.
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Functions of the Council: Clause 69
(e) ‘monitor and inspect pharmacy premises and other premises where pharmaceutical care is provided’
modified to
Functions of the Council: Clause 80
(e) ‘monitor and inspect pharmacy practice where pharmaceutical care is provided’
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Licensing of corporate bodies: Clause 84 (Bill) and Clause 93 (Act 857)
‘(1) The Board may grant a licence to a body corporate or a government institution of satisfied that (a) the applicant is fit to carry on the business of mixing, compounding, preparing or supplying restricted medicines by retail and
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Licensing of corporate bodies: Clause 84
(1b) the applicant’s business is carried on under the supervision of a superintendent pharmacist
modified to
Licensing of corporate bodies: Clause 93
(1b) the business of the applicant is carried on under the supervision of a superintendent pharmacist
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Power of closure: Clause 99 (Bill) and Clause 108 (Act 857)
(1) An inspector may close premises that sell or supply restricted medicines where there are grounds to believe that a health hazard may exist on the premises or where there are unlicensed’
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Entry of premises: Clause 97
(a) to inspect the registration of a pharmacist, pharmaceutical care providers or the licence of premises
modified to
Entry of premises: Clause 106
(a) to inspect the registration of a pharmacist, pharmaceutical support staff or pharmaceutical company
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Regulations: Clause 101 (Bill) and Clause 111 (Act 857)
(e) prescribe conditions including the type of premises for the issue of general and limited licence of the Council
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Supervision of pharmacy: Clause 77
‘ A person shall not open or permit any other person to open premises to the public under the description of ‘pharmacy’, ‘dispensary’, ‘chemist’, ‘drug store’ or any other similar description unless a registered pharmacist is on the premises to supervise the dispensing of medicines or medication
moved to
Offence: Clause 110 (c) and text maintained
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Interpretation: Clause 102 (Bill) and Clause 112 (Act 857)
premises” includes pharmacy premises or other facility authorized for practitioners under this Part and a Pharmacy department of a hospital, clinic, a house, building, structure, tent, caravan, land, ship, boat, an aircraft mechanically propelled device and other place or facility in which pharmaceutical services are offered.
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Licensing of premises: Clause 83 – Deleted
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