Zambia - Obtain a Pharmaceutical License (Wholesale Dealer)

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Procedure

Apply In-Person:

1. To apply for a pharmaceutical license 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 upon visiting the Zambia Medicine Authority office, find the form here application form.
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 necessary attachments to the office.
6. Pay the fee as per given in the “Fees” section of this page.
7. After the completion and verification of all the required documents, the license will be accessible.
8. Upon completion of above steps the applicant gets the license in a stipulated period of time.

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Required Documents

• Proof of qualification of Responsible Person, Suitably Qualified Person, Head of Production and Head of Quality Control.
• Passport (for non-Zambians)
• NRC
• Proof of registration of Responsible Person, Suitably Qualified Person, Head of Production and Head of Quality Control.

Office Locations & Contacts

Zambia Medicines Regulatory Authority
Head Office
Tuleteka Road, Off Makishi Road
P.O. Box 31890
Lusaka, Zambia
Tel: 0211-236241
Email: [email protected]
Website: link.
Contact link.

Eligibility

• A person(s) who wishes to deal with pharmaceutical products.

Fees

• Fee units: ZMK15,833
• Amount 30 Ngwee/unit: ZMK4,750.00

Validity

• One year and is subject to renewal.

Documents to Use

• Application form link.

Sample Documents

Please attach sample completed documents that would help other people.

Processing Time

• It depends on verification of provided documents.

Related Videos

Videos explaining the procedure or to fill the applications.Attach videos using the following tag <& video 
type='website'>video ID|width|height<&/video&> from external websites.Please remove the '&' inside the tags 
during implementation.Website = allocine, blip, dailymotion, facebook, gametrailers, google video, html5, 
metacafe, myspace, revver,sevenload, viddler, vimeo, youku, youtube width = 560, height = 340, Video ID = Can be 
obtained from the URL of the webpage where the video is displayed.
e.g In the following url 'http://www.youtube.com/watch?v=Y0US7oR_t3M' Video ID is 'Y0US7oR_t3M'.

Instructions

Please provide other instructions related to the certificate/documents.
e.g. The state office has held birth records since january 1908.

Required Information

• Name(s) of business
• Physical Address
• Postal Address
• Business premises
• Particulars of business proprietor(s)
• Products to be manufactured, sold or dealt in
• Type of manufacture
• Particulars of Responsible Person, Suitably Qualified Person, Head of Production and Head of Quality Control.

Need for the Document

• The license allows the holder to deal in pharmaceutical products in Zambia.

Information which might help

• Pharmaceutical Act of Zambia link.

Other uses of the Document/Certificate

• It also allows the holder to sell, stock or exhibit or offer for sale, or distribute Homoeopathic Medicines.

External Links

Place some external links which might help.

Others

More information which might help people.