Similar to other professions, registering a pharmacy in Nigeria follows a structured process that requires adherence to specific regulatory guidelines. These processes ensure that pharmacies operate within established frameworks to maintain professional standards and safeguard public health. This article offers a detailed guide on who qualifies to set up a pharmacy in Nigeria, how to do so, and provides operational guidelines. It also discusses whether a foreigner can own a pharmacy in Nigeria and outlines the requirements for setting up an online pharmacy in the country.
HOW MANY TYPES OF PHARMACIES ARE THERE IN NIGERIA?
Before diving into the registration process, it is crucial to understand the different types of pharmacies one can establish in Nigeria.
Retail Pharmacy: Popularly referred to as a “Chemist”, this is the most common type of pharmacy. A retail pharmacy caters to the general public by dispensing medications prescribed by doctors. Medications are sold directly to the patients who are the end users.
Hospital Pharmacy: This type of pharmacy can be owned by either the Government or privately and are usually found within the premises of a hospital. These types of pharmacies are usually stocked with more specialized medications and provide medications for only hospitalized patients.
Community Pharmacy: Medications are supplied and sold with or without prescriptions. A common activity peculiar to this type of pharmacy is offering counseling services at the time of dispensing drugs to patients and engaging in health promotion programs.
Wholesale Pharmacy: These pharmacies sell medications in bulk to other pharmacies, hospitals, and clinics who then sell to others who will then administer it to the patients.
Manufacturing Pharmacy: As the name suggests, these pharmacies manufacture and distribute pharmaceutical products to the interested persons.
The registration and licensing procedures for each type of pharmacy vary and we will consider them below.
WHAT AGENCY REGULATES THE REGISTRATION OF PHARMACISTS IN NIGERIA
The Pharmacists Council of Nigeria (PCN) is the primary agency that regulates the registration and licensing of a pharmacy in Nigeria as well as the licensing of a pharmacist. According to Section 1 of the Pharmacists Council of Nigeria Establishment Act, 2022, the PCN is established to regulate and control the practice of the pharmacy profession in all ramifications. Other agencies include the Corporate Affairs Commission (CAC), and the National Agency for Food and Drugs Administration and Control (NAFDAC).
The CAC regulates the incorporation and registration of businesses in Nigeria, while the NAFDAC amongst other functions, regulates and controls the importation, exportation, manufacture, advertisement, distribution, sale, and use of food, drugs, cosmetics, medical devices, bottled water, chemicals and detergents.
HOW DO I REGISTER A PHARMACEUTICAL COMPANY IN NIGERIA
The following steps are to be followed to register a pharmaceutical company in Nigeria;
REGISTRATION WITH CORPORATE AFFAIRS COMMISSION
This is the first step to setting up a pharmaceutical company in Nigeria otherwise, your proposed pharmacy cannot undergo registration and licensing with the Pharmacists Council of Nigeria without presenting its registration documents. A pharmacy may be registered as a private company or a business name (this is only applicable in cases where a retail pharmacy is solely owned by a licensed pharmacist).
Requirements for registration of a pharmaceutical company with the Corporate Affairs Commission are as follows;
1. Minimum of 2 proposed names for reservation
2. Minimum of 1 member of the company to serve as director and shareholder (NB: In cases where the owner isn’t a licensed pharmacist, a licensed pharmacist must be a director of the company)
3. Qualifying certificate (where applicable)
4. Valid Government ID cards of directors and shareholders (a National ID card, Permanent Voters ID card, International Passport, and Driver’s License will suffice)
5. Signature of directors and shareholders of the proposed pharmacy
6. Contact details of the directors and shareholders such as; residential address, email, phone number, etc.
REGISTRATION AND LICENSING WITH THE PHARMACISTS COUNCIL OF NIGERIA
Registration and licensing with the Pharmacists Council of Nigeria takes place after registration with the Corporate Affairs Commission. Because there are various requirements for the different types of pharmacies, we will consider the requirements for each type as classified by the Pharmacists Council of Nigeria.
Registration and License Requirements for Retail, Distribution, and Importation Premises in Nigeria
The following are some of the documents to be submitted to the Registrar, Pharmacists Council of Nigeria, through the Director of Pharmaceutical Services of the State where the pharmacy is to be operated;
- Application letter to register the premises;
- Duly filled Form B (PCN Application form for registration of premises)
- Photocopy of annual license 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;
- Companies registration documents
- Legal agreement between the Superintendent Pharmacist and his employer 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;
- NYSC discharge or exemption letter where applicable
Registration and license requirements for pharmaceutical manufacturing premises in Nigeria
The requirements are similar to those of retail, distribution, and importation outfits listed above, and include the following;
- List of products to be manufactured;
- Organogram;
- List of staff qualifications and duties;
- Factory layout;
- Production flow chart;
- List of equipment in the production and quality control department;
- Source and water treatment facilities
- Water analysis report of raw and treated water;
- List and source of suppliers of raw materials and packaging materials;
- Standard Operating Procedures (SOP);
- Standard Cleaning Procedures;
- Inspection fees-Draft of N30,000.00 payable to the Pharmacists Council of Nigeria
Registration and license requirements for hospital pharmacies in Nigeria
Some of the requirements are as follows;
- Application letter to register the pharmacy
- Application form
- Photocopy of annual license to practice/Application for retention of the name of the Pharmacist in charge.
- Prescribed inspection and registration fee in bank draft payable to PCN
- Legal agreement between the Pharmacist in charge and the employer (where applicable)
- Photocopy of NYSC discharge certificate
- Company’s incorporation documents (where applicable)
- List of staff in the hospital Pharmacy showing qualifications and duties.
- Design layout of pharmacy
- Standard operating procedure
- List of equipment in production and quality control unit.
- List of products being produced by the pharmacy
- Organogram
Upon submission of the above requirements, an inspection of the proposed pharmacy premises is carried out by the Pharmacist Council of Nigeria to ensure it meets the required standards for pharmacy practice. Any deficiencies noted during the inspection must be rectified before approval is granted. Once the premises pass the inspection, the pharmacy must apply for an operational license, which involves paying the prescribed fee.
CAN A NON-PHARMACIST OWN A PHARMACY IN NIGERIA?
A non-pharmacist can own a retail pharmacy in partnership with a licensed pharmacist, but cannot own a retail pharmacy on his or her own. See Section 6 of the Registration and Licensing of Pharmaceutical Premises Regulations.
CAN A FOREIGNER REGISTER PHARMACY IN NIGERIA
A foreigner who is a licensed pharmacist in Nigeria can own a pharmacy in Nigeria so long as He / She has satisfied the license requirements to operate in Nigeria.
On the other hand, a non-pharmacist who is a foreign national can own a pharmacy in Nigeria so long as He / She is in partnership with a licensed pharmacist who will serve as a Superintendent pharmacist. Such foreigners will also have to satisfy certain conditions outlined in the relevant investment and pharmacy regulations some of which include obtaining relevant permits and meeting minimum capital requirements.
ONLINE PHARMACY REGISTRATION
The increasing integration of technology into healthcare has led to the rise of online pharmacies. Registration of online pharmacies is governed by the Online Pharmacy Regulations 2021. To establish an online pharmacy in Nigeria, the following steps are required:
The pharmacy must be registered as a physical entity with the Pharmacists Council of Nigeria. See section 1 of the Online Pharmacy Regulations 2021.
Some of the requirements for registration include;
- Application letter to register the premises;
- Photocopy of annual license 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;
- Companies registration documents
- Legal agreement between the Superintendent Pharmacist and his employer 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;
- NYSC discharge or exemption letter where applicable. See Section 2 of the Online Pharmacy Regulations 2021.
In addition to the above, the applicant must ensure compliance with the applicable data protection laws and guidelines.
CONCLUSION
Like every other professional service within Nigeria and around the world, compliance with the license guidelines provided by the Pharmacists Council of Nigeria is a continuous process even after registration as licenses are required to be renewed annually and pharmacists are required to be involved in continuous legal education. All of the above are however essential to ensure quality service delivery within the industry.
Are you ready to set up your pharmacy in Nigeria and you need help with the process, contact us here or through the Whatsapp icon on this page and we’ll attend to you.
Leave a Reply