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Difference between revisions of "Uganda - Renew a Pharmaceutical Manufacturing Facility"

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(Office Locations & Contacts)
Line 52: Line 52:
 
Fax:(256) 41-255758<br>
 
Fax:(256) 41-255758<br>
 
email: ndaug@nda.or.ug<br>
 
email: ndaug@nda.or.ug<br>
website: www.nda.or.ug<br>
+
website:[https://www.nda.or.ug/National Drug Authority]<br>
  
 
'''Pharmaceutical Society of Uganda'''<br>
 
'''Pharmaceutical Society of Uganda'''<br>
Line 66: Line 66:
 
City: Kampala Capital City<br>  
 
City: Kampala Capital City<br>  
 
Email Address: info@kcca.go.ug Email this Agency<br>  
 
Email Address: info@kcca.go.ug Email this Agency<br>  
Website: www.kcca.go.ug<br>  
+
Website:[https://www.kcca.go.ug/Kampala capital city Authority]<br>  
  
 
'''Ministry of Local Government'''<br>
 
'''Ministry of Local Government'''<br>
Line 75: Line 75:
 
Fax: +256-041 258127/347339<br>
 
Fax: +256-041 258127/347339<br>
 
E-mail: ps@molg.go.ug<br>
 
E-mail: ps@molg.go.ug<br>
www.[https://www.molg.go.ug Ministry Website]<br>
+
Website:[https://www.molg.go.ug/ Ministry website]<br>
  
'''Kampala Capital City Authority'''<br>
 
'''Head Office'''<br>
 
Plot 1-3 Sir Appolo Kaggwa Road<br>
 
PO BOX 7010 Kampala, Uganda<br>
 
Tel: +256 204 660000, +256 414 581294<br>
 
Email Address: info@kcca.go.ug<br>
 
Website: www.kcca.go.ug<br>
 
  
 
'''Or''' Contact your Municipal Council offices across the country Municipal Regional Offices<br>
 
'''Or''' Contact your Municipal Council offices across the country Municipal Regional Offices<br>
Line 114: Line 107:
 
Phone: +256 772 489 466<br>
 
Phone: +256 772 489 466<br>
 
Email Address: info@entebbe.go.ug<br>
 
Email Address: info@entebbe.go.ug<br>
Website:[http://www.entebbe.go.ug Enttebe Municipality]<br>
+
Website:[http://www.entebbe.go.ug Entebbe Municipality]<br>
  
 
'''Bushenyi District Local Government'''<br>
 
'''Bushenyi District Local Government'''<br>
Line 135: Line 128:
 
Phone: +256 392888974<br>  
 
Phone: +256 392888974<br>  
 
Email Address: info@kasese.go.ug / kasese1@gmail.com<br>
 
Email Address: info@kasese.go.ug / kasese1@gmail.com<br>
Website:[http://www.kasese.go.ug Kasese Municipalit]<br>
+
Website:[http://www.kasese.go.ug Kasese Municipality]<br>
  
 
'''Kitgum Municipal Council HQ'''<br>
 
'''Kitgum Municipal Council HQ'''<br>
Line 142: Line 135:
 
Phone:++256-772-356-866<br>
 
Phone:++256-772-356-866<br>
 
Email Address:info@kitgummunicipalcouncil.go.ug<br>
 
Email Address:info@kitgummunicipalcouncil.go.ug<br>
www.[kitgum.go.ug<br>
+
Website:[https://kitgum.go.ug/Kitgum District]<br>
 
 
  
 
'''Mubende District Local Government'''<br>
 
'''Mubende District Local Government'''<br>
Line 150: Line 142:
 
Phone: +256-392080149<br>  
 
Phone: +256-392080149<br>  
 
Email Address: mubende@yahoo.com<br>
 
Email Address: mubende@yahoo.com<br>
 
  
 
'''Hoima Municipal Council HQ'''<br>
 
'''Hoima Municipal Council HQ'''<br>
Line 163: Line 154:
 
Phone:+256 0414696923<br>
 
Phone:+256 0414696923<br>
 
Email: info@kiramc.go.ug<br>
 
Email: info@kiramc.go.ug<br>
Website:[www.kiramc.go.ug Kira Municipality]<br>
+
Website:[http://www.kiramc.go.ug/ Kira Municipality]<br>
  
 
'''Nansana Municipal Council HQ'''<br>
 
'''Nansana Municipal Council HQ'''<br>
Line 177: Line 168:
 
Email Address: mskmuncou@gmail.com<br>
 
Email Address: mskmuncou@gmail.com<br>
 
[https://www.ppdaproviders.ug/index.php?page=ypdes&sl=4&tgt=6&aph=&sn=all%20PDEs&sp=all%20PDEs&st=asc&tp=v&id=890 contact Link Masaka]
 
[https://www.ppdaproviders.ug/index.php?page=ypdes&sl=4&tgt=6&aph=&sn=all%20PDEs&sp=all%20PDEs&st=asc&tp=v&id=890 contact Link Masaka]
 +
  
 
==Eligibility==
 
==Eligibility==

Revision as of 13:57, 2 August 2020

Procedure

  1. Application for a renewal of a Licence to Manufacturer drugs shall be made using form 19.
  2. The application shall be accompanied by the following
    • a)A list of drugs to be manufacturer.
    • b)A certified copy of the certificate of registration of the pharmacist to be in charge of the manufacturing process.
    • c)The certificate of qualification of the key persons to be involved in the manufacturing process.
    • d)The prescribed fees.
  3. Premises applying for renewal of both wholesale and retail licenses are required to have at least two Professional Auxiliary Staff (PAS).
  4. Licenses will not be renewable for applicants with unsatisfactory required records of operations or transactions.
  5. Licenses shall be cancelled where it is confirmed that:
    • a)Unqualified staff have been allowed to handle drugs or have been left in charge of the drug outlet.
    • The drug outlet has been involved in stocking and/or selling drugs beyond those prescribed by the respective license or unregistered, unauthorized, smuggled or counterfeit drugs.
    • In case the Pharmacist or in-charge of drug shop ceases to be responsible for the outlet before the expiry of the operating Licence issued in his/her name. It shall be his/her responsibility to return to NDA the said license.
    • Such a Pharmacist or in-charge shall not be issued with a new Licence if he/she has not returned the valid license previously issued in his or her name.
    • Any drug outlet that does not renew its license for at least one year without written acceptable and prior approved reasons shall, on reapplication, be treated as a new applicant with respect to location and fees.
  6. Applicants must also comply with these and all other statutory and regulatory requirements.
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Required Documents

All Renewing applicants should submit the following not later than 31st January

  • Clearance from Ministry of Trade, Industry and Cooperatives for non-nationals
  • The completed application forms
  • Letter of acceptance from the professional in charge plus a copy of his/her relevant Registration/Enrolment Certificate.
  • The previous year’s licenses number filled in the space provided on the form for application for license
  • A valid Certificate of Registration of the supervising pharmacist as issued by the registrar of the Pharmacy Council, Ministry of Health.
  • A letter of commitment from the supervising pharmacist.
  • For Retail/Wholesale pharmacies (human): a copy of the certificate of the dispenser or approved registered or enrolled nurse.
  • For retail/wholesale pharmacies (veterinary):a copy of the certificate of the qualified veterinary professional (Veterinary Surgeon or Animal Husbandry Officer).
  • In case of change of pharmacist, the applicant must submit a certified copy of the articles and Memorandum of association or Partnership Deed showing the Supervising Pharmacist as one of the Directors or Partners respectively.
  • In case of change of ownership, the applicant must submit evidence of the sale such as copies of the sales agreement between the seller and the buyer and the updated /current articles and memorandum of association.
  • Two black and white passport photos of the qualified professional in charge.
  • A copy of the certificate of the qualified medical/pharmaceutical /veterinary profession in charge.
  • 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/Municipal 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
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. Box 3774, Kampala, Uganda.
Tel:256-414-348796
Email:psupc@psu.or.ug

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

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


Or Contact your Municipal Council offices across the country Municipal Regional Offices
Municipal council Headquarters Offices spread across the 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 Government Plot No,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 Government
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 Government Lira - Gulu Road.
P.O.Box 49, Lira, Uganda
Phone: +256(0473) 420219
Email Address:
Website:Lira Municipality

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

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

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


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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 for renewal Licence for a pharmaceutical manufacturing facility.

Fees

Explain the fees structure which is required for obtaining the certificate/document.

Validity

Valid for 1 year.

Documents to Use

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

Please attach sample completed documents that would help other people.

Processing Time

Processing takes 14 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'.

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Instructions

Please provide other instructions related to the certificate/documents.
e.g. The state office holds birth records since january 1908.

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


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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

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


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Others

More information which might help people.