How to Renew a Pharmaceutical Manufacturing Facility In Uganda

Renew a Pharmaceutical Manufacturing Facility In Uganda By Online

An application to renew the Licence to Manufacturer drug is to be done using Form 19.
The application should be supported by the following
- a)A list of the drugs that are that are to be manufactured.
- b)A certified duplicate of the registration certificate of the pharmacist responsible for the production process.
- c)The certification of the principal persons who will be part of making.
- d)The fee schedule.
premises that are applying for renewal of retail and wholesale licenses are required to possess at minimum two Professional Auxiliary staff (PAS).
Licenses cannot be renewed in the event of applicants not submitting satisfactory documents of operations or transactions.
Licenses are canceled if it is proven that:
- a)Unqualified personnel have been permitted to deal with drugs or been placed in charge of the drug shop.
- The drug store is involved with the stocking and/or selling more than the amount authorized by the respective license or illegal, unregistered or counterfeit drugs.
- If the Pharmacist or the person in charge of the drug shop ceases to have responsibility for the establishment prior to the expiration date of the operating licence issued under his/her name. It is the responsibility of the pharmacist to give back to NDA the license.
- The Pharmacist or the person in charge will not be issued new license if he/she did not return the original valid license issued under his or her name.
- A drug store which fails to keep its current license valid for a minimum of one year without written acceptance and approved prior reasons must upon reapplication be considered an applicant who is new in relation to fees and location.
Candidates must also adhere to these requirements, along with any other regulatory and statutory requirements.

Required Documents For Renew a Pharmaceutical Manufacturing Facility

All renewing applicants must be submitting the following information no after 31st January

Clearance from the Ministry of Trade, Industry and Cooperatives for non-nationals
The filled application forms
Letter of acceptance from the professional in charge plus a copy of his/her relevant Registration/Enrolment Certificate.
The license number for the previous year was filled in the area on the application form for license
Valid Certificate of Registration for the supervising pharmacist granted by the registry at the Pharmacy Council, Ministry of Health.
A commitment letter from the pharmacist who is supervising.
For pharmacies that sell retail or wholesale (human) A duplicate of the certification of the dispenser or an approved registered or registered nurse.
For pharmacies that sell retail or wholesale (veterinary):a duplicate of the certification of the veterinary professional with a degree (Veterinary Surgeon , Animal Husbandry Officer).
In the event of a change in pharmacist, the person applying for the change must provide a certified copy of the Memorandum and Articles of Association or Partnership Deed that lists the pharmacist who is supervising being one of Directors and Partners or Partners.
In the event of a change in ownership, the buyer must provide proof of the sale, such as copies of the sales contract with the vendor and buyer as well as the current or updated memorandum of agreement and articles.
Two passport photographs of the certified professional responsible.
A copy of the certificate of the qualified medical/pharmaceutical /veterinary profession in charge.
Certificate of destruction for expired drug prior to the issuance of a new Licence.
Prior approval by the National Drug Authority to pharmacies who had a license to run in the final year.
Proof of Services/business-registration/registering.
Original registration certificate (Business name)
Certificate of Incorporation (Company)
The Proof Letter of Uganda Registration Services Bureau
Original KCCA/Municipal receipt from the year prior, indicating current 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.
Prior Certificate of suitability for premises
Prior Licence to run an online or wholesale pharmacy
A previous Certificate of Full Name as a Pharmacist
If there is a change in the supervisor of the pharmacist from one pharmacy to the next, evidence of the pharmacist’s role as a director must be provided 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
Website : Drug Authority

Pharmaceutical Society of Uganda
Plot 22 Tufnell Drive, Kamwokya Kampala
P.O. PO Box 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
Address for Postal Service: PO BOX 7010 Kampala, Uganda
Cityof Kampala: Kampala Capital City
Mailing Address: info@kcca.go.ug Email this Agency
Site : Capital city Authority

Ministry of Local Government
Workers house
2nd Floor Southern Wing
P.O. 7037, Kampala
Tel: +256-041 341224
Fax: +256-041 258127/347339
E-mail: ps@molg.go.ug
Website: Ministry Website

or contact the Municipal Council offices across the country . Regional Offices of the Municipality
Municipal council headquarters offices are scattered all over the nation.

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 Authorities
District Local Government Mbarara – Kasese road.
P.O Box 01 Bushenyi, Uganda
Phone: +256-485-43575
Email Address: info@bushenyi.go.ug
Website: 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 Governance
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
The District Local Government of 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
Municipal Local Government District 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.
Except for those exempted by Section 8(2) of the Trade Licensing Act are eligible to renew a licence for a manufacturing facility for pharmaceuticals.

Validity

Valid for one year.

Processing Time

Processing time is 14 days for processing.

The Information You Need

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 is known)
Business Information
Address of the principal building
The exact location of the properties that this application concerns.
Specific Activities in connection with the application
Structure and capital formation

Information that can be useful

All applicants should gather applications from the following places:
District Assistant Drug Inspector (DDI) is based at the DHO’s office. DHO in each district.

Regional office, located in the following addresses:

Central Region-Premier complex Nakawa.
South Eastern Region-Rippon Gardens, jinja
Eastern Region-Kwapa Road, Tororo
Northern Region-Erute Road. Lira
Western Region- Mugwana Center,Plot30,Old Toro Road Hoima
South Western Region-Kamukuzi, Mbarara
West Nile Region-Plot1 Mount. Wati Road Anafiyo-Arua

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

External Links

Source

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