How to Apply to Establish a Pharmaceutical Manufacturing Facility In Uganda

Apply to Establish a Pharmaceutical Manufacturing Facility In Uganda By Online

  1. Permits or licences to operate a Pharmaceutical Manufacturing Facility can be obtained from the National Drug Authority.
    • The pharmaceutical manufacturing industry is controlled by the National Drug policy and Authority Act.
    • Anyone who plans to submit an application for the Licence are advised to be familiar with the applicable laws and regulations to ensure that they are in compliance.
    • The manufacturing of, importation, prescription and sales of prescription drugs in Uganda is governed by the National Drug Authority.
  2. Make sure you fill out the proper application form in accordance with the guidelines of the National Drug Authority.
    • The production pharmacist has to be supported by qualified personnel , such as pharmacists pharmacy technicians or certified chemists.
  3. After filling out the form, proceed to pay the prescribed amount
  4. Fill out the form along with the payment slips to pharmacist The officer responsible for the area in which your premises is situated or to the close to a health inspector office whose officers will conduct an inspection of your premises.
    • NDA will not be obligated to open premises for licence without following these guidelines and will not be responsible for any claims resulting from financial loss.
  5. There should be a supervising registered pharmacist with the business prior to when the application is made, since this is a common licensing procedure.
  6. You must collect Your Pharmaceutical Manufacturing Facility Licence certificate from the place where you submitted your application within one day of the day the application was submitted to the National Drug Authority in case there isn’t a rejection.

Notice: It is a shared responsibility of the person in-charge as well as the owner/applicant for the shop to make sure that the certification of the person in charge who submitted it to NDA is genuine and valid.

Required Documents For Apply to Establish a Pharmaceutical Manufacturing Facility

  • Clearance from the Ministry of Trade, Industry and Cooperatives for non-nationals.
  • Certificate of destruction for expired medications prior to the issuance of a new Licence.
  • Previous approval from the National Drug Authority to pharmacies who had a license to be operating in the closing year.
  • Proof of Services/business-registration/registering.
  • Original registration certificate (Business name)
  • Certificate of Incorporation (Company)
  • A Proof Letter from the Uganda Registration Services Bureau.
  • Original KCCA receipt from the year prior, indicating that there was business.
  • The original rent and tenancy agreement with the Landlord to the new company.
  • Original Trading License issued from the previous year to allow an already established business.
  • A previous certificate of the suitability of premises
  • Prior Licence to run an online or wholesale pharmacy
  • A previous Certificate of Full Name as Pharmacist
  • If there is a change in the supervisor of the pharmacist from one pharmacy to the next, evidence that the pharmacist from the company serves as director must be submitted to the National Drug Authority.

Office Locations and Contacts

National Drug Authority Secretariat office
Plot No. 19. Rumee Towers, Lumumba Avenue,
P.O. Box 23096 Kampala, Uganda.
Tel: +256-414-255665, +256-414-347391/2
Fax:(256) 41-255758
email: ndaug@nda.or.ug
Site : Drug Authority.

Pharmaceutical Society of Uganda
Plot 22 Tufnell Drive, Kamwokya Kampala
P.O. 3774 Kampala, Uganda.
Tel:256-414-348796
Email:psupc@psu.or.ug

The Kampala Capital City Authority Head Office
Tel: +256 204 660000, +256 414 581294
Physical Address: Plot 1-3 Sir Appolo Kaggwa Road
Mailing Address: PO BOX 7010 Kampala, Uganda
Kampala Capital City Kampala Capital City
Contact Email: info@kcca.go.ug Email this Agency
Website: Capital City Authority

Ministry of Local Government
Workers are in the House
2nd Floor Southern Wing
P.O. 70737 Kampala
Tel: +256-041 341224
Fax: +256-041 258127/347339
E-mail: ps@molg.go.ug
Web site: Ministry website

or Call for your Municipal Council offices across the country . Regional Offices of the Municipality
Municipal council headquarters offices are scattered all over the entire country.

Gulu Municipal Council HQ
C/O District Local Government Airport road
P.O.BOX 201 Gulu
Phone: +256 751000910
Email Address: Gulumnc@gmail.com

Mbarara Municipal Council HQ
Council Building (White House)
District Local Governance Plot 12 Galt Road, Mbarara
P. O. Box 290 Mbarara, Uganda.
Phone: +256 485420955
Website : Mbarara Municipality

Jinja Municipal Council HQ
Town Hall.
Mpumudde/Kimaka,Avenue.
District Local Government Busoga Square
P.O Box 720, Jinja, Uganda
Email Address: info@jinja.go.ug

Entebbe Municipal Council HQ
District Local Government Circular Road, Plot 2A Entebbe.
P.O Box 32 Entebbe, Uganda
Phone: +256 772 489 466
Email Address: info@entebbe.go.ug
Website : Entebbe Municipality

Bushenyi District Local Governance
District Local Government Mbarara – Kasese road.
P.O Box 01 Bushenyi, Uganda
Phone: +256-485-43575
Email Address: info@bushenyi.go.ug
Site: Bushenyi Municipality

Lira Municipal Council HQ
District Local Authority Lira District Local Government Lira Gulu Road.
P.O.Box 49 Lira, Uganda
Phone: +256(0473) 420219
Email Address:
Website:Lira Municipality

Kasese District Local Authorities
District Local Authorities Rukooki, Kasese
P.O Box 250, Rukooki, Kasese, Uganda
Phone: +256 392888974
Mail Address: info@kasese.go.ug / kasese1@gmail.com
Website : Kasese Municipality

Kitgum Municipal Council HQ
District Local Governance Achua County Kitgum
P.O Box 28,Kitgum, Uganda
Phone:++256-772-356-866
Email Address:info@kitgummunicipalcouncil.go.ug
Website : District

Mubende District Local Government
The District Local Government of Mubende Town
P.O Box 93,Mubende Uganda
Phone: +256-392080149
Email Address: mubende@yahoo.com

Hoima Municipal Council HQ
District Local Government Hoima, Kampala Road
P.O.Box 149, Hoima, Uganda
Phone: +256 772 566776
Email Address: info@hoimamunicipal.go.ug
contact Link Hoima

Kira Municipal Council
P.O Box 25749, Kampala, Uganda
Phone:+256 0414696923
Email: info@kiramc.go.ug
Website : Kira Municipality

Nansana Municipal Council HQ
District Local Governance Nansana Town Wakiso
P.O Box 7218, Kampala Uganda
Phone: +256 702 459893, +256 704 308272
Contact Email: info@nansana.go.ug

Masaka Municipal Council HQ
District Local Government Plot 11 Elgin Street
P.O.BOX Masaka, 201 Masaka
Phone:+256-481-432596
Contact Email: mskmuncou@gmail.com
contact Link Masaka

Eligibility

  • Any person of 18 years carrying out business in Municipality/Division/Town/City/Kampala City Council Authority’s jurisdiction.
  • Other than those exempted by Section 8(2) of the Trade Licensing Act are eligible to apply for a Manufacturing facility licence.

Fees

The fees for licences range from Ugsh500,000 to Ugsh1.200,000m.

Validity

Valid for one year.

Processing Time

Maximum processing 10 days.

Instructions

  • The manufacturing process has to be monitored with the help of a pharmacist registered living in Uganda for every manufacturing line.
  • The procedure to control quality and assurance must be conducted monitored by a pharmacist who is registered and a resident of Uganda.
  • The pharmacist responsible for manufacturing processes and the pharmacist responsible for the quality and control should be separate from each other.
  • The Pharmaceutical manufacturing process must be in line with NDA Guidelines for Best Manufacturing Practices(GMP)

Requirements Information

  • Name of License Holder Proposed (if you are a limited company, you must specify the your country and the year of registration)
  • License Number (if available)
  • Business Information
  • Principal address
  • The exact location of the properties that this application concerns.
  • Specific Activities in relation to the application
  • Capital Formation and Structure.

Information that could be helpful

  • All applicants should gather application forms from these places:
  • District Assistant Drug Inspector (DDI) is based at the DHO’s office. DHO in each district.
  • Regional office, located in the following places:
  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-Plot 1 Mt. Wati Road Anafiyo-Arua

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

  • A pharmacist will not be permitted to supervise operations of pharmaceuticals within two establishments and must inform NDA at the time of applying:
  • The length of time and the duration for which the employee is expected to be physically present at all location
  • The name and qualifications for that of Professional Auxiliary Staff (PAS) to substitute for the pharmacist during times of absence from the physical area, and attend to the pharmacy of another
  • There is no way to open or transfer a drug shop anyplace without préalable approval given to the establishment through the National Drug Authority.
  • A shop selling drugs is classified as unlicensed and shut down its doors if National Drug Authority has not received the renewal application of licenses prior to the 31st day of the year that follows.
  • The facility is closed and operations shall cease immediately when the premises are licensed. Candidates are advised to apply for renewal of their licenses prior the expiration of their current licenses.

External Links

Source

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