Non-Tariff Barriers

Non-Tariff Measure

NTM classification

B15: Authorization requirements for importers 

Date when the measure came into force

16 July 2013 

Publication where the measure is specified

Application for variation to registered pharmaceutical product DOC. No DAR/FOM/050 

Regulation where the measure is specified

Application form-Variations to a registered pharmaceutical product 

Country/Region applying the measure

Uganda 

Coded list of objectives

X: For purposes n.e.s. 

Description of the measure

Please complete each section of this application form electronically as a Word Document and as a scanned signed PDF file. Please ensure that the electronicand the printed versions of the completed form accompany your submission.
1. Application details
1.1 Variation type:
(tick all applicable options)
Annual notification (AN) Immediate notification (IN)
Minor variation (Vmin) Major variation (Vmaj)
1.2 Grouping of variations
Single variation
Grouped variations
1.3Finished Pharmaceutical Product (FPP) Name - Registration and File Numbers: e.g. Isoniazid Tablets 100mg – 0000/06/1997, A000
1.4Applicant details
Applicant
(Marketing Authorization Holder)
Contact person responsible for this application Title/Designation: First name: Surname name
Contact person's job title
Contact person's postal address
Contact person's email address
Contact person's phone number
2. Summary of proposed changes
For multiple variations (grouped variations), reproduce this section and provide separate
summaries for each proposed variation.
2.1 Variation title and number e.g. Minor variation # 30a: Change in batch size of the finished product - Up to and including a factor of ten (10) compared to the biobatch
2.3 Reason for change:
2.4 Date of implementation (for Immediate Notifications only):
3. Documentation checklist
The following documents have been submitted together with this application form
Note: All documents must be provided for this application to be valid.
Quality Information Summary (QIS)- (Only for registered pharmaceutical products for human use)
For FPPs that have an agreed upon QIS, the QIS should be revised and submitted with any revised sections highlighted. A QIS should be completed in its entirety (regardless of the proposed change). It should include information on all strengths, with any changes highlighted (e.g. in red type).
Supporting documentation
All supporting documents as stipulated for the change in the Guidelines on Variations to a Registered Pharmaceutical Product for Human use are included in this submission
4. Declaration
(by Marketing Authorization Holder)
.Please check all declarations that apply.
I declare that:
For each change all conditions as stipulated in the NDA Guidelines on Variations to a Registered Pharmaceutical Product for Human use, number DAR/GDL/005for the change requested are fulfilled.
There are no changes being made other than those applied for in this submission, except
for possible editorial changes. Any other changes will be applied for separately.
The information submitted is true and correct 

Reference of the measure

Sections 1-4 

Measure also domestic

Yes 

Products affected by the measure.

Description

Pharmaceutical Products 

Countries/Regions affected by the measure.