Uganda - Renew a Pharmaceutical Manufacturing Facility

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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

The Pharmaceutical Society of Uganda - Head Office,
Pharmacy House,
Plot 1847
Kyambogo Banda
P.O.Box 3774
Kampala Uganda
Tel: +256 414 348 796 / +256 392174280
Email: psupc@psu.or.ug
Email: Link

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 : ndaug@nda.or.ug
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 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

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Sample Documents

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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'.

Instructions

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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

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

• https://www.nda.or.ug/Linked%20publications/2019%20Licensing%20Guidelines-compressed%20(1).pdf
• https://www.ugandanconventionuk.org/about-uganda/investment-information/business-registration-procedur.

Others

More information which might help people.