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<p><b>New page</b></p><div>==Procedure==<br />
#Application for a renewal of a Licence to Manufacturer drugs shall be made using form 19.<br />
#The application shall be accompanied by the following<br />
#*a)A list of drugs to be manufacturer.<br />
#*b)A certified copy of the certificate of registration of the pharmacist to be in charge of the manufacturing process.<br />
#*c)The certificate of qualification of the key persons to be involved in the manufacturing process.<br />
#*d)The prescribed fees.<br />
#Premises applying for renewal of both wholesale and retail licenses are required to have at least two Professional Auxiliary Staff (PAS).<br />
#Licenses will not be renewable for applicants with unsatisfactory required records of operations or transactions.<br />
#Licenses shall be cancelled where it is confirmed that:<br />
#*a)Unqualified staff have been allowed to handle drugs or have been left in charge of the drug outlet.<br />
#*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.<br />
#*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. <br />
#*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.<br />
#*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.<br />
#Applicants must also comply with these and all other statutory and regulatory requirements.<br />
<br />
==Required Documents==<br />
''All Renewing applicants should submit the following not later than 31st January''<br><br />
*Clearance from Ministry of Trade, Industry and Cooperatives for non-nationals<br />
*The completed application forms<br />
*Letter of acceptance from the professional in charge plus a copy of his/her relevant Registration/Enrolment Certificate.<br />
*The previous year’s licenses number filled in the space provided on the form for application for license<br />
*A valid Certificate of Registration of the supervising pharmacist as issued by the registrar of the Pharmacy Council, Ministry of Health.<br />
*A letter of commitment from the supervising pharmacist.<br />
*For Retail/Wholesale pharmacies (human): a copy of the certificate of the dispenser or approved registered or enrolled nurse.<br />
*For retail/wholesale pharmacies (veterinary):a copy of the certificate of the qualified veterinary professional (Veterinary Surgeon or Animal Husbandry Officer).<br />
*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.<br />
*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.<br />
*Two black and white passport photos of the qualified professional in charge.<br />
*A copy of the certificate of the qualified medical/pharmaceutical /veterinary profession in charge.<br />
*Certificate of destruction of expired drugs prior to issuance of another Licence.<br />
*Previous Approval from National Drug Authority to pharmacies which had a Licence to operate in the ending year.<br />
*Proof of Services/business-registration/registering.<br />
*Original certificate of registration (Business name)<br />
*Certificate of incorporation (Company)<br />
*Proof Letter from Uganda Registration Services Bureau <br />
*Original KCCA/Municipal receipt for the previous year indicating existing business<br />
*Original rent and tenancy agreement from the Land lord for the new business.<br />
*Original trading License for the previous year for already existing business.<br />
*Previous Certificate of suitability of premises <br />
*Previous Licence to operate a retail or wholesale Pharmacy<br />
*Previous Certificate of Full Name as a Pharmacist <br />
*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. <br />
<br />
==Office Locations & Contacts==<br />
'''The Pharmaceutical Society of Uganda - Head Office''',<br><br />
Pharmacy House,<br><br />
Plot 1847 <br> <br />
Kyambogo Banda<br> <br />
P.O.Box 3774 <br> <br />
Kampala Uganda<br> <br />
Tel: +256 414 348 796 / +256 392174280<br> <br />
Email: psupc@psu.or.ug<br> <br />
Email: [https://psu.or.ug/contacts/ Link]<br> <br />
<br> <br />
'''National Drug Authority - Head Office''',<br><br />
Plot 19 Lumumba Avenue (opposite TWED plaza)<br><br />
Kampala, Uganda<br><br />
P. O Box 23096, <br><br />
Kampala, Uganda<br><br />
Tel: +256 [0]417 788 100<br><br />
Directorate of Product Safety : +256 [0]417 788 124<br><br />
Directorate of Inspectorate Services : +256 [0]417 788 129<br><br />
Email : ndaug@nda.or.ug<br><br />
Website :[https://www.nda.or.ug/contact-us/ Link]<br><br />
<br><br />
==Eligibility==<br />
*Any person of 18 years carrying out business in Municipality/Division/Town/City/Kampala City Council Authority’s jurisdiction.<br />
*Except those who are exempted under Section 8(2) of the Trade Licensing Act are eligible for renewal Licence for a pharmaceutical manufacturing facility.<br />
<br />
==Fees==<br />
Explain the fees structure which is required for obtaining the certificate/document.<br />
<br />
==Validity==<br />
Valid for 1 year.<br />
<br />
==Documents to Use==<br />
Please attach documents that can be used by people. e.g. links<br />
<br />
==Sample Documents==<br />
Please attach sample completed documents that would help other people.<br />
<br />
==Processing Time==<br />
Processing takes 14 days. <br />
<br />
==Related Videos==<br />
Videos explaining the procedure or to fill the applications. <br />
Attach videos using the following tag <&video type='website'>video ID|width|height<&/video&> from external websites. <br />
Please remove the '&' inside the tags during implementation.<br />
Website = allocine, blip, dailymotion, facebook, gametrailers, googlevideo, html5, metacafe, myspace, revver, <br />
sevenload, viddler, vimeo, youku, youtube<br />
width = 560, height = 340, Video ID = Can be obtained from the URL of webpage where the video is displayed.<br />
e.g In the following url 'http://www.youtube.com/watch?v=Y0US7oR_t3M' Video ID is 'Y0US7oR_t3M'.<br />
<br />
==Instructions==<br />
Please provide other instructions related to the certificate/documents.<br />
e.g. The state office holds birth records since january 1908.<br />
<br />
==Required Information==<br />
*Name of Proposed License Holder (if a limited company please state country and year of registration)<br />
*License Number (if known)<br />
*Business Details<br />
*Address of principal premises<br />
*Exact location of premises to which this application relates<br />
*Specific Activities in respect of which this application is made<br />
*Structure and Capital formation <br />
<br />
<br />
==Need for the Document==<br />
Please provide the need for the procedure. e.g. Birth Certificate - why do we need to have a birth certificate? <br />
<br />
==Information which might help==<br />
*All applicants should collect application forms from the following locations:<br />
*District Assistant Drug Inspector (DDI) based in the office of the DHO in every district.<br />
Regional office located at the following locations:<br />
#Central Region-Premier complex Nakawa.<br />
#South Eastern Region-Rippon Gardens, jinja<br />
#Eastern Region-Kwapa Road, Tororo<br />
#Northern Region-Erute Road,Lira<br />
#Western Region- Mugwana Center,Plot30,Old Toro Road, Hoima<br />
#South Western Region-Kamukuzi, Mbarara<br />
#West Nile Region-Plot1 Mt. Wati Road Anafiyo-Arua<br />
NDA headquarters, Plot No. 46-48. Lumumba Avenue, Kampala<br />
<br />
==Other uses of the Document/Certificate==<br />
Please explain what are other uses of obtaining this document/certificate.<br />
e.g. Birth Certificate can be used as proof of identity.<br />
<br />
==External Links==<br />
*https://www.nda.or.ug/Linked%20publications/2019%20Licensing%20Guidelines-compressed%20(1).pdf<br />
*https://www.ugandanconventionuk.org/about-uganda/investment-information/business-registration-procedur.<br />
<br />
<br />
==Others==<br />
More information which might help people.<br />
<br />
[[Category:Uganda]]<br />
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