Uganda - Apply to Establish a Pharmaceutical Manufacturing Facility

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Procedure

The applicant to manufacturer pharmaceuticals must apply for an annual license through NDA.

1. Licence or Permit for Pharmaceutical Manufacturing Facility can be obtained from National Drug Authority.
   • Manufacturer of pharmaceuticals is regulated under the National Drug policy and Authority Act.
   • All applicants intending to apply for this Licence, are strongly advised to familiarize themselves with the relevant laws and regulations and ensure compliance.
   • The manufacture, importation, prescription and sale of drugs in Uganda are governed by the National Drug Authority.
2. Fill up the appropriate application form as described by the National Drug Authority.
   • The production pharmacist must be supported by suitably qualified personnel such as pharmacists, pharmacy technicians or approved chemists.
3. After filling the form proceed to pay the prescribed fee
4. Submit the dully filled in form and attached with pay slip to the Pharmacist Officer in charge of the area in which the premises is located or nearby health inspector office whose officers shall carryout inspection of your premises.
   • NDA shall not be obliged to Licence premises opened without following these procedures and shall not be liable to any claims of resultant financial loss.
5. There must be a supervising registered Pharmacist associated with the firm before the application is submitted, as this is a general licensing process.
6. Collect your Pharmaceutical Manufacturing Facility Licence certificate from where your application was submitted within a day from the date the application was received at National Drug Authority in case there is no rejection.

Note: It is a joint responsibility of the in- charge and the applicant/owner of the drug shop to ensure that the certificate of the in-charge submitted to NDA is valid and authentic.

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Required Documents

• Clearance from Ministry of Trade, Industry and Cooperatives for non-nationals.
• Certificate of destruction of expired drugs prior to issuance of another Licence.
• Previous Approval from National Drug Authority to pharmacies which had a Licence to operate in the ending year.
• Proof of Services/business-registration/registering.
• Original certificate of registration (Business name)
• Certificate of incorporation (Company)
• Proof Letter from Uganda Registration Services Bureau.
• Original KCCA receipt for the previous year indicating existing business.
• Original rent and tenancy agreement from the Land lord for the new business.
• Original trading License for the previous year for already existing business.
• Previous Certificate of suitability of premises
• Previous Licence to operate a retail or wholesale Pharmacy
• Previous Certificate of Full Name as a Pharmacist
• In case of change of supervisor by the pharmacist from one pharmacy to another evidence that the company pharmacists as a director should be presented to National Drug Authority.

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

• Any person of 18 years carrying out business in Municipality/Division/Town/City/Kampala City Council Authority’s jurisdiction.
• Except those who are exempted under Section 8(2) of the Trade Licensing Act are eligible to apply for a pharmaceutical manufacturing facility Licence.

Fees

Licence fees ranges between Ugsh500,000 and Ugsh1.200,000m.

Validity

Valid for 1 year.

Documents to Use

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

Sample Documents

Please attach sample completed documents that would help other people.

Processing Time

Maximum processing 10 days.

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, googlevideo, html5, metacafe, myspace, revver, 
sevenload, viddler, vimeo, youku, youtube
width = 560, height = 340, Video ID = Can be obtained from the URL of 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

• The manufacturing process must be supervised by a registered pharmacist resident in Uganda for each production line.
• The process of quality control and quality assurance shall be under the supervision of a registered pharmacist and a resident in Uganda.
• The pharmacist in charge of the manufacturing process and the pharmacist in charge of quality control and quality assurance shall be independent of each other.
• The Pharmaceutical manufacturing operations must comply with NDA Guidelines on Good Manufacturing Practices(GMP)

Required Information

• Name of Proposed License Holder (if a limited company please state country and year of registration)
• License Number (if known)
• Business Details
• Address of principal premises
• Exact location of premises to which this application relates
• Specific Activities in respect of which this application is made
• Structure and Capital formation.

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

• All applicants should collect application forms from the following locations:
• District Assistant Drug Inspector (DDI) based in the office of the DHO in every district.
• Regional office located at the following locations:

1. Central Region-Premier complex Nakawa.
2. South Eastern Region-Rippon Gardens, jinja
3. Eastern Region-Kwapa Road, Tororo
4. Northern Region-Erute Road,Lira
5. Western Region- Mugwana Center,Plot30,Old Toro Road, Hoima
6. South Western Region-Kamukuzi, Mbarara
7. West Nile Region-Plot1 Mt. Wati Road Anafiyo-Arua

NDA headquarters, Plot No. 46-48. Lumumba Avenue, Kampala

• A pharmacist shall not be allowed to supervise pharmaceutical operations of two premises and must indicate to NDA at the time of application:
• The time and duration he/she is expected to be physically present in each premises
• The name and qualification of the Professional Auxiliary Staff (PAS) to deputize the pharmacist during the hours his/her physical absence, attending to the other pharmacy
• No persons shall open up or transfer any drug outlet anywhere without the prior approval of the location by the National Drug Authority.
• A drug outlet shall be considered unlicensed and should close its operations if the National Drug Authority has not received the application for renewal of licenses by 31st Jan of the proceeding year.
• The premises shall be subject to closure and all operation shall cease forthwith until when licensed. Applicants are encouraged to apply to renew their licenses before the expiry of the current licenses.

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

• External Link

Others

More information which might help people.