PROCEDURE FOR SETTING UP PHARMACY AND A PHARMACEUTICAL MANUFACTURING BUSINESS IN UGANDA

PROCEDURE FOR SETTING UP PHARMACY AND A PHARMACEUTICAL MANUFACTURING BUSINESS IN UGANDA.

LAWS APPLICABLE MAY INCLUDE,

1. The National Drug Policy And Authority Statute, 1993.
2. The National Drug Policy And Authority (Issue Of Licenses I Regulations, 1993.
3. The National Drug Policy And Authority (Certificate Of Suitability Of Premises) Regulations, 1995.
4. Companies Act Of 2012
5. Partnership Act
6. Registration Of Names Act

• In Uganda one may operate wholesale pharmacy, pharmaceutical manufacturing business, retail pharmacy or just trade in terms of exporting and importing .
• However for anyone to engage in any of the above, he or she must obtain ALICENSE to operate the same from National Drug Authority.

The following are some of the licenses one can apply for.
– License to operate a pharmaceutical manufacturing business,
– License to operate wholesale pharmacy,
– License to operate a retail pharmacy,
– Certificate of Suitability of premises (Manufacturing business),
– license/permit to import,

– License /permit to Export,

– Product license,

It is a requirement that all pharmacies and pharmaceutical industries should engage the services of a qualified pharmacist however Pharmaceutical industries may require more than one pharmacist depending on their size

This post shall only deal with the procedure for setting up a pharmacy whether whole sale on retail and the pharmaceutical industry/manufacturing in Uganda.

• Register a business entity either as a company or partnership indicating pharmaceutical business as one of your objectives (see the post on how to incorporate a company in Uganda), incorporating a qualified pharmacist as director in case of a body corporate or as a partner in case of partnership.
• The pharmacist to be engaged should be registered and also resident in Uganda, in case of a body cooperate or partnership at least one of the directors must be a pharmacist resident at Uganda.
• Choose suitable premises for a pharmacy which should have all the appropriate compartments, decorations and facilities in place.
• Upon getting a suitable premises consult the supervisor at NATIONAL Drug Authority on its suitability for his opinion.
• Arrange the premises ready and then apply to National Drug Authority or any of their agents at the district for inspection of your premises upon payment of inspection fee.
• After inspection of your premises, national drug authority will you certificate of inspection and suitability.
• Certify copies of certificate of incorporation, company form 20, memorandum and Articles of association at Registrar of Companies.
• Prepare your application for a license to operate a pharmacy or pharmaceutical manufacturing business attaching all the above documents among others.
• Obtain payment slip from National Drug Authority or any of their agent and the district and pay accordingly.
• Attach the payment receipt on your application for license to operate a pharmacy or pharmaceutical manufacturing business and submit it to secretary national drug authority.
• Secretary, National Drug Authority shall review you application for consideration; it may be approved on rejected.
• If it is approved your license will be prepared for your operations in Uganda.
• Upon approval and issuance of license by Secretary, National Drug Authority Uganda, you may commence your pharmacy in Uganda.
• Upon getting a license proceed to obtain Tax Identification Number from Uganda Revenue Authority for your business entity and the directors or partners if they do not have.
• You are supposed to get a trading license also from the local authorities i.e. Town council, divisions, municipality or city for operation of your business.

Author is A regional transactions legal consultant (ADVOCATE) at NOA REGIONAL ASSOCIATED ADVOCATES AND LEGAL CONSULTANTS
Email address: onlinetransactionconsultancy@gmail.com.

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NOTE: whereas the author has made necessary efforts to ensure the accuracy of this post, it is not intended to provide specific legal advice to a particular individual as individual situations may differ.

For specific technical / legal transaction advice on this subject matter and related subject, you may contact the author at online consultancy fee, or contact any transaction legal consultant of your choice.
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