How to Register Pharmacy in Zambia?

Registering a pharmacy in Zambia involves several steps and requires compliance with the Zambia Medicines Regulatory Authority (ZAMRA). Please note that the registration process may be subject to change, so it's essential to verify the most up-to-date information from the Zambia Medicines Regulatory Authority (ZAMRA). Here is a step-by-step guide to registering a pharmacy in Zambia:

Step 1: Preliminary Research

Before starting the registration process, conduct thorough research on the requirements, regulations, and guidelines set forth by the Zambia Medicines Regulatory Authority (ZAMRA). This research will help you understand the specific procedures and necessary documentation for registering a pharmacy.

Step 2: Premises and Location

Select an appropriate location for your pharmacy. Ensure that the premises meet the minimum standards required by ZAMRA. The location should be accessible to the public and comply with any zoning requirements for pharmaceutical establishments.

The following partition for the premises shall apply

(a) In the case of for a pharmacy with a closed dispensary:

• front shop: minimum size of 16 m2;
• dispensary: minimum size of 12 m2; with a minimum with of 3m;
• total space: minimum size of 28 m2; and
• The dispensary can be used as a consultation room

(b) In the case of a pharmacy with an open dispensary:

• front shop: minimum size of 16m2;
• dispensary: minimum size of 9m2;
• office, consultation room: minimum size of 4m2;
• total minimum size of 29m2; and
• store room: to be optional.

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Step 3: Qualified Person

• Designate a qualified and registered pharmacist to be in charge of the pharmacy. This individual will be responsible for overseeing the day-to-day operations and ensuring compliance with pharmaceutical regulations.
• A registered pharmacy shall engage the services of a full-time registered pharmacist as a responsible person, except that the responsible person shall not be:

1. in full-time employment elsewhere;
2. on leave, for less than six months, from a full-time job; or
3. on full-time educational studies.

• Where a Locum Pharmacist is to stand in for the Responsible Person for a considerable period of time, the Locum Pharmacist shall be subject to the restrictions imposed on the responsible person.

Step 4: Business Registration

Register your pharmacy as a business entity with the Patents and Companies Registration Agency (PACRA) in Zambia. Choose a suitable business name and complete the necessary registration forms.

Step 5: Application Submission

Obtain the application form for pharmacy registration from ZAMRA or download it from their official website. Fill out the form completely and accurately, providing all the required information and supporting documents.

Step 6: Required Documents

Gather all the necessary documents to accompany your application. These may include:

1. Certificate of incorporation or business registration from PACRA.
2. Valid identification documents for the designated pharmacist in charge.
3. Proof of premises ownership or a lease agreement for the pharmacy location.
4. Detailed floor plan and layout of the pharmacy premises.
5. Pharmacists' practicing certificates.
6. A copy of the applicant's tax identification number (TIN).
7. Any other documentation specified by ZAMRA.

Step 7: Inspection and Assessment

Once you have submitted your application and supporting documents, ZAMRA will conduct an inspection of the pharmacy premises. During the inspection, they will assess whether the pharmacy complies with all the necessary requirements and regulations.

Step 8: Review and Approval

ZAMRA will review your application, inspection report, and supporting documents. If everything meets the regulatory standards, they will approve your application.

Step 9: Payment of Fees

Pay the required registration fees and any other applicable charges as determined by ZAMRA.

Step 10: Issuance of Registration Certificate

After successful completion of all the above steps, ZAMRA will issue a pharmacy registration certificate. This certificate indicates that your pharmacy is legally registered and authorized to operate in Zambia.

Step 11: Ongoing Compliance

Ensure that your pharmacy continues to comply with all ZAMRA regulations and guidelines. Regular inspections may be conducted by ZAMRA to ensure ongoing compliance.

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Procedure to Register Pharmacy in Zambia

1. To apply for a registration certificate of pharmacy in Zambia, the applicant will have to contact the Zambia Medicine Authority office, for the main office visit link.
2. Make sure that you have all the documents that are listed under the “Required Documents” section of this page.
3. An application form will be provided to the applicant at the Zambia Medicine Authority office.
4. Once understanding the guideline properly, the applicant has to fill in all the necessary information in the application form.
5. Submit the application form with the necessary attachments to the office.
6. Once the application has been verified, it will be forwarded to the registrar for approval as per the Pharmaceutical Act of Zambia.
7. An inspection will be held to check the suitability of the pharmacy to be registered.
8. If the inspector approves the application for registration, the registrar will issue a certificate of registration together with a copy of the by-laws certified as having been duly approved and registered.
9. Pay the fee as given in the “Fees” section of this link (https://www.zamra.co.zm/fees/).
10. After the completion of the above steps, the certificate will be accessible.
11. The applicant gets the registration certificate in a stipulated period of time.

Required Documents

1. Proof of qualification of Responsible Person, Suitably Qualified Person, Head of Production and Head of Quality Control.
2. Valid professional certificate for the responsible person. Proposed Operational Plan of the Pharmacy.
3. Sketch of the floor plan of the premises. Business levy permit from the local authority. Fire certificate from the local authority.
4. A valid certificate of incorporation, business name registration, registration of a cooperative and incorporation of a trust.
5. Passport (for non-Zambians). NRCs
6. Proof of registration of Responsible Person, Suitably Qualified Person, Head of Production and Head of Quality Control

Office Locations & Contacts

ZAMRA Head Office

Zambia Medicines Regulatory Authority

Plot No. 2350/M

P. O Box 31890

Off Kenneth Kaunda International Airport Road

Lusaka, Zambia

Phone: +260 211 432 350

Phone: +260 211 432 351

Required Information

1. Name(s) of business Physical Address
2. Postal Address
3. Business premises Particulars of the applicant Name of Business PACRA Registration No. Physical Address
4. Postal Address Notification Address
5. Particulars of the Personnel

Please keep in mind that the registration process can take some time, and it's crucial to be patient and diligent throughout the procedure. Always consult the official ZAMRA website or contact them directly for the most up-to-date information and guidance.

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