Uganda - Register a product with National Drug Authority

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Procedure

• Stages involved to register with Uganda National Drug Authority in Uganda is procedural. Every process needed must be followed to the later. For both locally manufactured products and imported products.
• Again, each part has classes under which products are registered such as Drugs, Foods, Innovation and Research, Cosmetics, Medical Devices, Herbal products, Narcotics, Pesticides, Packaged Water etc.
  
  

Stage 1: Documentation.
Here you are required to present the necessary documents specified by UNDA to register each products. These documents differ in some aspect depending on the class of product you want register.

• Some of the documents include Power of Attorney or contract manufacturing Agreement;
• Manufacturing license and free sale certificate,
• Trademark registration, certificate of incorporation/business name and many more.
  

Note:All the necessary documents must be found satisfactory before any other process can be carried out.
Stage 2: Import Permit:

• If the documents complied with the UNDA requirements, permit to import samples of products is issued to the applicant. The applicant is requited to import specified samples to be used for vetting and Lab analysis.
  

Stages 3: Vetting of samples
At this stage, samples of products presented are vetted. Such vetting includes checking the labels, leaflets, drugs information.

• The name of the medicine brand name,
• name and address of the manufacturer,
• production and expiry date,
• Batch no, provision for EDA NO and so on.
  
  

There are minimum requirements for product labeling such as Documents to be submitted during the vetting are

• copies of import permit and receipt of payment
• dossier according to UNDA format for drugs and pesticides
• 3 samples for each product
• Letter of invitation for inspection.
• Comprehensive Certificate of Analysis
  

Stage 4: Lab Analysis:

• After the vetting is done, you are required to bring some samples for lab analysis. You’ve to submit specified quantities of sample products along with copies of receipt for the processing fee and application letter for the submission of samples.
• Then your product(s) goes to lab for analysis to ensure compliance with standard specification.
  

Stage 5: Meeting

• At this stage, if the product(s) successful meets the lab test, then the product will be presented at the meeting. Here, decisions are taken on whether the product qualifies to be given UNDA license Number or not. They usually seat two times over the product. If the product meets all the requirements, license number will be issued.
  

Stage 6: Collection of Notification Number

• Once the product is given license number, you will go ahead to collect the notification number. You’ve to pay the specified amount for the license certificate and present the receipt and your notification number will be given to you. You are now qualified to import the product for commercial purpose while you wait for the certificate to come out. It takes six months or so for your certificate to be ready. The certificate usually last for the period of five (5) years

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Required Documents

• One duly filled application form including their supporting documents.
• Three (3) samples of the Drug with batch certificates of analysis.
• An original Certificate of Pharmaceutical Product on official papers of the issuing competent drug regulatory authority.
• A site master file in case the product is manufactured at a plant(s) not inspected and approved by National Drug Authority.
• Non-refundable application fee for registration of medicines in Uganda and GMP inspection fees for facilities not yet inspected by National Drug Authority.
• Proof Letter from Uganda Registration Service Bureau.
• Certificate of suitability of premises
• Licence to operate a pharmacy.
• Certificate of full Names as a pharmacist.
• Evidence of payment of prescribed fees.

Office Locations & Contacts

National Drug Authority - Head Office,
Plot 19 Lumumba Avenue (opposite TWED plaza)
Kampala, Uganda
P. O Box 23096,
Kampala, Uganda
Tel: +256 [0]417 788 100
Directorate of Product Safety : +256 [0]417 788 124
Directorate of Inspectorate Services : +256 [0]417 788 129
Email : [email protected]
Website :Link

Eligibility

• All Individuals or companies interested in Pharmaceutical Business both in human and animal Drug products in Uganda and other related products are eligible to register their drugs with Uganda National Drug Authority.

Fees

Licence fee: Ugshs. 500,000.

Validity

Validity: 5 Year

Documents to Use

Please attach documents that can be used by people. e.g. links

Sample Documents

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Processing Time

Maximum Processing Time: 21 Days.

Related Videos

Videos explaining the procedure or to fill the applications. 
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Instructions

• The National Drug Authority, is the National Agency for Drug Administration and Control body in Uganda that the statutory responsibility of regulating and controlling the manufacture, importation, exportation, distribution, advertisement, sale and use of drugs, food, packaged water, medical devices, chemicals, raw materials, cosmetics, and agrochemicals (called regulated products).
• in Uganda is a scientific and research organization with a mandate of ensuring availability at all times of essential, efficacious and cost effective drugs to the entire population of Uganda as a means of providing satisfactory healthcare.
• NDA has another mandate to protect consumers from the use and consumption of unwholesome and dangerous regulated products. It does this by assigning NDA numbers to satisfactory products as well as continuous regulatory activities at production and distribution locations and the ports of entry.

Required Information

• Completed NDA application form.
• Certificate of Incorporation with the Business registration Bureau, if a company
• Five (5) copies of the product dossier
• Three (3) packs of the products samples
• Certificate of Pharmaceutical Products (COPP) duly issued and authenticated
• Current Pharmacists license to practice issued by the Pharmaceutical Board of Uganda.
• Premises Registration License from Pharmaceutical Board of Uganda.
• Certificate of Registration with trademark registry in the Ministry of finance

Need for the Document

 Please provide the need for the procedure. e.g. Birth Certificate - why do we need to have a birth certificate?

Information which might help

• The Authority shall give reasons in writing when it suspends or revokes, or amends conditions of registering the Drug.Likewise, the applicant should also give reasons for terminating registration of a product/Drug.
• The National Drug Authority (NDA) was established with a mandate of ensuring availability at all times of essential, efficacious and cost effective drugs to the entire population of Uganda as a means of providing satisfactory healthcare.
• This procedure provides you information related to registering a product with National Drug Authority in Uganda. This is done to Protect people's health by regulating safety and quality of pharmaceutical products.
• Regulation & legislation of pharmacy practice in Uganda.

Other uses of the Document/Certificate

Please explain what are other uses of obtaining this document/certificate.
e.g. Birth Certificate can be used as proof of identity.

External Links

• National Drug Authority
• External Link 2
• External Link 3

Others

More information which might help people.