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Pharmaceutical manufacturing license
Regulatory
Details
Purpose:
Regulatory
Application Fees:
Nil
License Fee:
Please see fees categories under the Download Forms/Info link below:
Maximum Processing Time:
1 Month for new applicants and 2 weeks for renewal
Related Websites:
www.nda.or.ug
Validity:
1 Year
Contact Office:
National Drug Authority
Renewal Fee:
Please see fees categories under the Download Forms/Info link below:
License Type:
License
Legal Basis:
National Drug Policy and Authority Act, Cap. 206. National Drug Policy and Authority (Licensing) Regulations, 2014
Requirements
Approval from NEMA.
Proof of payment of the prescribed fees.
Certificate of compliance with the internationally accepted good manufacturing practice guidelines adopted by the authority.
Certificate of qualification of the key personnel to be involved in the manufacturing process as may be determined by the authority.
Certificate of Suitability of premises.
Certified copy of Certificate of registration of the Pharmacist to be in charge of the manufacturing process.
List of drugs to be manufactured and proof of registration of the drugs.
Download Forms/Info
Fees for pharmaceutical manufacturing
Application form
Professional guidelines for renewal for pharmaceutical manufacturing facilities
Agencies
National Drug Authority
Phone:+256 41 255665 / 347391/2
Physical Address:46/48 Lumumba Avenue
Postal Address:P. O. Box 23096 Kampala, Uganda
Jurisdiction:National
Email Address:ndaug@nda.or.ug
Website:
www.nda.or.ug
Operating Hours:Moday to Friday, 8:00am-5:00pm (excluding weekends and public holidays)
Directions:
View Directions
National Drug Authority (Nakawa-Central)
Phone:+256 312261548
Physical Address:Nakawa Central
Postal Address:
Email Address:
Website:
Operating Hours:
Directions:
View Directions
National Drug Authority (Tororo-Eastern)
Phone:+256 454445195
Physical Address:6 Busia Road South Bukedi Cooperative Building 3rd 453,Tororo Uganda
Postal Address:
Email Address:
Website:
Operating Hours:
Directions:
View Directions
National Drug Authority (Hoima-Western)
Phone:+256 465440688
Physical Address:Old Fortportal Road, Hoima Uganda
Postal Address:
Email Address:
Website:
Operating Hours:
Directions:
View Directions
National Drug Authority (Lira-Northern)
Phone:+256 473420652
Physical Address:Erute road, Lira Uganda
Postal Address:
Email Address:
Website:
Operating Hours:
Directions:
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