Introduction:
Pharmacy practice in Nigeria, for international best practices and in line with Good Pharmacy Practice (GPP), is regulated by the Pharmacy Council of Nigeria (Establishment) Act, 2022 No. 31, which was enacted by the National Assembly of the Federal Republic of Nigeria and received the assent of the then President of the Federal Republic of Nigeria, Muhammadu Buhari, GCFR on the 16th day of August 2022, which doubles as the commencement date for the Act. It is an Act to repeal the Pharmacists Council of Nigeria Act Cap. P17, Laws of the Federation of Nigeria, 2004. From the nomenclature, the Act made an immediate change to what was obtainable under the repealed Act from the Pharmacist Council of Nigeria to the Pharmacy Council of Nigeria, a Federal Government parastatal established and saddled with the responsibility, amongst others, of regulating and controlling the standard of education, training and practice of pharmacy and related matters in Nigeria,[1] including regulating Pharmacy Technicians and Patent and Proprietary Medicines Vendors (PPMVs).[2]
The Act is divided into 12 (twelve) parts[3] of 72 (seventy-two) sections which borders on various provisions. However, to have a scopic focus on this article, most of the sections to be considered would be as relevant to enlightenment of pharmacist and business owners of pharmacy premises.
Establishment Of The Pharmacy Council Of Nigeria (Pcn)[4]
There is established the Pharmacy Council of Nigeria by the Act, referred to as “the Council”. The Council, which is a body corporate with perpetual succession and a common seal; may sue or be sued in its corporate name; and may acquire, hold, or dispose of any property, movable or immovable subject to the provisions of the Land Use Act, for the purpose of performing any of its functions under the Act. While Section 2 and 3 provides for the composition of the Council and appointment and tenure of members of the Council respectively, section 4 of the Act provides for the functions and Powers of the Council.
Functions And Powers Of The Pharmacy Council Of Nigeria (Pcn)[5]
The Council, among other functions and powers vested on it by the provisions of section 4 of the Act and any other provision of the Act, shall administer the provisions of the Act; regulate the standard of pharmacy practice and business in Nigeria; determine the standard of knowledge and skills to be attained by
persons seeking to become registered members of the pharmacy profession and review such standard; determine and set standards for the degree courses in faculties of pharmacy in Nigerian universities; establish requirements and standards for registration of intern pharmacists for internship and any other experiential training to enable a person obtain practical experience in the practice of pharmacy; establish requirements for the grant of licence to intern pharmacists to undergo internship training and engage in the practice of pharmacy in an approved institution under the direct supervision of registered pharmacists; establish and maintain a register of persons entitled to practice as members of the pharmacy profession and publish the list of members; inspect, approve, licence and regulate the registration and practice or operations in all pharmaceutical premises where drugs, medicines and poisons are manufactured, imported, exported, distributed, stored, dispensed or sold in Nigeria, based on Good Pharmaceutical Practice Standards (GPP); establish and maintain a register of premises used for the manufacture, storage, importation, exportation, distribution, sale and dispensing of drugs, poisons, medicines, and medical devices and accessories; regulate, formulate, publish and review the code of conduct, ethics and practice of the pharmacy profession and code of conduct for pharmacy technicians, patent medicine vendors and pharmaceutical marketers; determine and set standards for the training of pharmacy technicians in schools and colleges of health technology approved by the Council; regulate and control the practice of pharmaceutical marketing and representations; regulate and control pharmacy practice in all its aspects and ramifications; and do such other things that are necessary to ensure the efficient performance of the functions conferred on the Council under this Act.
The Council has also identified and associated itself with the vast responsibility under the Act to determine what standard of knowledge and skill are to be attained by persons seeking to become Pharmacists in Nigeria; establish and maintain a register of pharmacists and pharmacy technicians and secure the publication from time to time of the list of those names as entered in the register; issue pharmacists Oath and Code of Ethics; appoint pharmaceutical inspectors to ensure the enforcement of the provisions of the law by inspection and monitoring of premises where pharmaceutical endeavours take place.[6] The Council in exercising its power[7] has also established zonal and state offices to enhance its operations and the performance of its functions under this Act.
Registers Of Pharmacists, Pharmacy Technicians, Premises, Satellite Medicine Facilities And Patent Medicines Shops[8]
The Act categorically provides for the registers that the Registrar in accordance with the rules made by the Council, must keep and maintain[9] —
- a register of pharmacists where the names, addresses, qualifications and other particulars of all persons who are entitled to be enrolled as provisional members or members of the profession who apply to the Council to be so registered shall be entered;
- a register of pharmacy technicians where the names, addresses, qualifications, and such other particulars of all persons who are entitled to be enrolled as pharmacy technicians who apply to the Council to be so registered shall be entered;
- a register of premises used by pharmacists, pharmacy technicians and patent medicine vendors, or any other person licensed by the Council for the manufacture, production, exportation, importation, stocking for research or any other purposes, storage, distribution, sale or dispensing of drugs and medicines, medical devices and accessories and the provision of other pharmaceutical products shall be entered; and
- any other register that the Council may require to be kept.
Essentially, it could be discerned from the provisions of the Act as above, that keeping and maintaining registers of pharmacist (provisional members or members of the profession),[10] pharmacy technicians and pharmacy premises presupposes the strict requirement of the Act for registration of pharmacist, pharmacy technicians and pharmacy premises, without which pharmacy practice and operation cannot be lawfully carried out. In other words, as the registration of pharmacists and pharmacy technicians is highly essential, likewise is also the registration of premises used for any kind of pharmacy operation to which members carry on pharmacy business, highly essential, legally required and ethically demanded under the Act.
Subject to the provisions of the Act, the Council may make rules with respect to the forms, contents, parts, and procedures for keeping and making of entries in any of the registers provided under the Act, as detailed above. The rules made by the council in particular makes provision for regulating the making and processing of applications for enrolment of provisional members or members and the registration of premises under the Act,[11] specifying the fees, including any annual subscription, to be paid to the Council in respect of any pharmacy operation.
Registration And Licensing Of Pharmaceutical Premises Regulations 2021
Notwithstanding the provisions of the Act repealing the Pharmacists Council of Nigeria[12] Act (the repealed Act), any person who is registered and all regulations and amendments made under the repealed Act shall be deemed to have been made under the Act[13]. By implication of this, the Registration and Licensing of Pharmaceutical Premises Regulations 2021 (the Regulation) made by the then Council prior to the Act becomes effective and operative.
All Pharmaceutical premises in Nigeria shall be registered with the Council, applications made to the Registrar and applicants shall complete an application form,[14] which shall be accompanied with the following documents[15]:
- Application letter to register the premises;
- Duly filled Form B (PCN Application form for registration of premises)
- Photocopy of annual licence to practice /application for retention of name on the Pharmaceutical Register (Form J)
- Prescribed inspection and registration fees in Bank Draft payable to the Pharmacists Council of Nigeria;
- Photocopy of letter of resignation from previous employment (if applicable);
- Letter of acceptance of resignation (if applicable);
- Letter of appointment in the new premises where applicable;
- Legal agreement between the Superintendent Pharmacist and his employer where applicable;
- Company’s Certificate of Incorporation (Evidence of registration of business name is acceptable from Pharmacist-owned retail premises);
- Article and Memorandum of Association (certified copy);
- Particulars of Directors as issued by Corporate Affairs Commission (CAC) (certified copy);
- Photocopy of NYSC Discharge or Exemption Certificate where applicable;
- Letter of undertaking by the Superintendent Pharmacist to the effect that he has only one pharmaceutical job;
- Letter of undertaking by the Managing Director of the Company to the effect that all pharmaceutical business will be left under the direct, personal control and management of the Superintendent Pharmacist;
- Pharmacists inter-state movement Form (where applicable);
- There must be a Pharmacist on the Board of Directors;
- Such application shall be accompanied with the Current Annual Licence of the Pharmacist Director.
The Regulations further provide for peculiar premises as related to premises to manufacture, wholesale distribution and importation centres, hospital pharmacy, retail pharmacy, patent and proprietary medicine vendors’ shop.[16]
The Council is the licensing authority for all pharmaceutical premises involved in the drug distribution throughout the supply chain. It may issue or grant license to registered pharmaceutical premises in Nigeria in line with Good Pharmacy Practice (GPP) and in accordance with the guidelines for registration[17].
A fully registered pharmacist is eligible to apply for the registration of a retail or distribution or importation pharmacy provided he has completed his National Youth Service Corps (NYSC) primary assignment and presents an NYSC Discharge or Exemption Certificate. The Pharmacist is expected to be up to date with Mandatory Continuing Professional Development (MCPD) programme of Pharmacists Council of Nigeria (PCN) (if eligible)[18].
Any place used for the purpose of dispensing, selling, compounding, distribution, storage, stocking, retailing, wholesale, manufacturing, importation, exportation of drugs and poisons, scientific offices or any other form of pharmaceutical activities shall be inspected and registered in accordance with the provisions of the Act. However, where an application is made and it appears to the Registrar that the premises to which the application relates do not comply with the requirements of the Act, the Registrar may refuse to register the premises and state the reasons for the refusal in writing. Also, where the Registrar is of the view that a licence should be suspended, revoked, withdrawn, canceled or restored, the holder of such licence shall, by notice, be required to give reasons within 14 days of receipt of such notice why the licence should not be suspended, revoked, withdrawn or cancelled.[19]The Council shall prescribe the fees for the registration and retention of premises, the fees which may vary as the Council may determine from time to time.[20]
From the foregoing, a person shall not operate premises where drugs, poisons, medicines, medical devices and medical accessories are sold, dispensed, distributed,
manufactured, stored, imported or exported unless he has complied with the Act and any regulation in force, and duly licensed by the Council. It is therefore essential that a seamless pharmacy operation requires the backing or understanding of the legal framework of pharmacy practice in Nigeria. Where any act or practice is inconsistent with the provisions of the Act, as well as the regulations and guidelines of the Council, such act or practice shall, to the extent of the inconsistency be void in relation to matters bordering on pharmacy practice in Nigeria.[21]
FOOTNOTES:
[1] Explanatory memorandum to the Act and Schedule to the Pharmacy Council of Nigeria (Establishment) Bill, 2022
[3] Arrangement of Sections -PART I to PART XII Pharmacy Council of Nigeria (Establishment) Act, 2022 (the Act)
[4] PART I of the Act
[5] Section 4 of the Act
[6] Brief History -www.pcn.gov.ng/about-us/
[7] Section 7 of the Act.
[8] PART IV of the Act.
[9] Section 16 of the Act
[10] Section 16 (1&2) of the Act.
[11] Section 17 of the Act.
[12] Cap P17, Laws of the Federation of Nigeria, 2004, ibid.
[13] Section 69 (1) of the Act.
[14] Regulation 1 and 2 of the Registration and Licensing of Pharmaceutical Premises Regulations 2021
[15] Regulation 2 (2) of the Registration and Licensing of Pharmaceutical Premises Regulations 2021;
www.pcn.gov.ng/registration-and-licensing/retail-distribution-and-importation-premises/
[16] Regulations 3,4,5, 6 and 7 of the Registration and Licensing of Pharmaceutical Premises Regulations 2021;
www.pcn.gov.ng/registration-and-licensing/
[17] Regulations 9 (1) (2) of the Registration and Licensing of Pharmaceutical Premises Regulations 2021
[18] Ibid 16
[19] Comprehensive provision of Section 22 of the Act.
[20] Section 23 of the Act.
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