Registration Of Pharmacies Flashcards
What types of licenses are issued by the council?
TWO types of licenses
● Wholesale license
● Retail license
What kind of pharmacies can be registered in 🇬🇭?
FIVE kinds of pharmacy are registered in 🇬🇭
● Retail Pharmacies
● Wholesale Pharmacies
● Retail and Wholesale Pharmacies
● Pharmacies within hospitals, clinics, and any other facility that requires a pharmacy.
● Manufacturing Wholesale Pharmacies (a different application form and guidelines has been designed for this kind of Pharmacy).
What classes of drugs can a pharmacy supply?
● Class A - prescription only medicines (POM)
● Class B - Pharmacist’s list of medicines (P) i.e. medicines that may be dispensed by a pharmacist without a prescription.
● Class C - over-the-counter (OTC) preparations.
What are the documents required for any prospective pharmacy?
- Completely filled prescribed application form
- Registrar General’s Documents:
i. Certificate of Incorporation
ii. Certificate to Commence Business
iii. Companies code
Object of Business must include Pharmacy Business.
What is required of the pharmacist registering a pharmacy?
⦿ At least 12 months of post registration practice in Ghana and
⦿ Must be employed full time for this proposed pharmacy.
What are the location requirements for preapproval of a retail pharmacy?
⦿ The structure shall be geographically and structurally permanent and the proposed Pharmacy shall be accessible to all clients
⦿ A washroom must be provided within the structure or within adjoining parts of
the structure.
⦿ The distance between the proposed site and other retail facilities shall be
400m by radius.
⦿ The size of the proposed premises shall be at least 36 square meters and ceiling height of at least 3.2m
⦿ The floor space shall include
i) Main customer area,
ii) Dispensary,
iii) Office
iv) A counselling area.
⦿ Portable water, a sink and a working surface for extemp should also be provided
What are the location requirements for preapproval of a wholesale pharmacy?
🔰A wholesale pharmacy is a pharmaceutical business registered in accordance with section 30 of the Pharmacy Act 1994, Act 489
⦿ The structure shall be geographically and structurally permanent and the proposed Pharmacy shall be accessible to all clients
⦿ A washroom must be provided within the structure or within adjoining parts of
the structure.
⦿ The size of the proposed premises shall be at least 36 square meters and ceiling height of at least 3.2m
⦿ A minimum of 4 rooms comprising of a reception, a storeroom, an office and a cashier’s room.
⦿ The reception should have waiting chairs for clients as well as a showcase with samples of the medicines
⦿ There should be no external shelves in the reception area.
⦿ The storeroom must be well ventilated and shelves and pallets must be provided.
⦿ The signboard should state the name and address with ‘WHOLESALE ONLY’ boldly written.
⦿ Council List of retailers and FDA list of manufacturers, registered drugs and guidelines on drug ads should be available.
✳️ The business of wholesaling should strictly comply with the standards of good wholesale practices.
What are the location requirements for preapproval of a wholesale/retail pharmacy?
⛔️ Not allowed in metropolitan areas
● The structure shall be geographically and structurally permanent and the proposed Pharmacy shall be accessible to all clients
● A washroom must be provided within the structure or within adjoining parts of the structure.
● The size of the proposed premises shall be at least 48 square metres.
● It is important that the physical arrangements within the premises be made in such a manner that the wholesale business does not interfere with the retail business.
How is pharmacy license renewal done?
Renewal shall be done every year and must be made before the 31st of January of the next year.
The renewal form is filled by the superintendent pharmacist
When submitting the form, a current written contract btn the pharmacist and the employer must be added.
Suspension of business
A pharmacy business should not be suspended for more than 2 years
What are some offences that can attract regulatory sanctions?
⦿ Continuous absence of pharmacist when the pharmacy is open
⦿ Display and supply of expired, unregistered, fake and substandard medicines
⦿ Supply of medicines from an unregistered premise
⦿ Improper record keeping on procurement and supply of restricted drugs
⦿ Operating in unsanitary conditions
⦿ Non renewal of license
⦿ Any unethical/unprofessional practices
⦿ Any act of commission or omission constituting a breach of standards.
What are the responsibilities of the sup pharmacist?
● Management of the pharmacy with respect to the keeping, preparing, dispensing and supply of medicines
● Active involvement in the selection of medicines for purchasing
● Active involvement in the the supply of medication to patients,
● To ensure that records are duly and properly kept.
● To prepare or supervise the preparation of extemporaneous preparations.
● To update himself and other staff of the pharmacy on new trends in the management of diseases and on other professional issues.
● To ensure that shelves and stocks are rid of deteriorated, expired, banned, fake substandard medicines.
● To ensure clean, decent and attractive professional environment.
● To uphold moral and professional conduct that will not bring the profession of Pharmacy into disrepute.
● To ensure that the premises is duly registered and staff have adequate training in providing the required services.
● To supply class A medicines only on prescription and ensure that class B medicines are only supplied to persons reasonably believed to be responsible.
What are the standards for good wholesale practices?
Any Pharmaceutical Company that engages in wholesale supply of medicine shall
- Be duly registered with the Pharmacy Council and hold a valid wholesale licence for that premises from which the business is conducted.
- A pharmacist shall supervise the supply of restricted drugs
- Medicines shall be supplied to only authorised person(s). Class A or B medicines shall be supplied on signed orders issued by an authorised person.
- The supply of medicines shall be by wholesale only
- Only medicines registered by the Food and Drugs Board shall be supplied.
- Appropriate records and documentation shall cover every transaction covering
pharmaceuticals. - Supply of all pharmaceuticals shall be made from the registered premises only
- Direct supply of pharmaceuticals shall not be made from vehicles, except deliveries made on appropriately signed orders.
- Pharmaceutical Wholesalers shall have available at all times all necessary information on pharmaceutical products they supply.
What is the process to go through for pharmacy registration?
Application to operate a pharmacy is made by duly completing and submitting the
prescribed application forms. (PA-I, PA-II and PA-III form).
1️⃣ Prospective applicant may obtain application forms from any of the Pharmacy Council offices.
2️⃣ Applicant shall then complete the forms appropriately and submit them
(together with all relevant documents including documents from the
Registrar-General’s) to the Pharmacy Council office responsible for the area
the applicant intends to operate. An application fee determined by the council
is paid at the point of submission.
3️⃣ A site inspection will be done by officers of the regional offices of the Pharmacy Council after which a recommendation will be made to the Council.
4️⃣ If the application is approved by the Pharmacy Council the applicant shall be
duly notified in writing and allowed six (6) months to prepare the premises for a final premises inspection.
5️⃣ The final inspection report is submitted to the Registrar and if the premises
conforms to specifications and other conditions stated in Section 3.0 of this
document, the applicant shall pay the prescribed registration fee for the issue
of the licence. A Pharmacy Council certificate shall be issued for the
commencement of the business.
6️⃣ The certificate issued in respect of the pharmacy shall include the name and
registration number of the Superintendent Pharmacist.
During the processing,
⦿ Upon receipt of the application an authorised officer of the Pharmacy Council shall inspect the proposed site for the pharmacy.
⦿ The Pharmacy Council shall not be under any obligation to approve an application because of financial commitments made by the applicant before approval
⦿ Approval granted by the Council is valid for a specified period of time.
⦿ ⛔️Approval of an application does not constitute authorization to commence bu siness until all conditions and requirements for the issuance of Licence are fulfilled.
⦿ ‼️The Council reserves the right to consider other applications for the same area after the period specified in the approval has elapsed.
