National Drug Policy and Authority (Fees) Regulations
·Statutory Instrument 5 of 2022·Current version · as at 04 February 2022
Enacted2022
Commenced01 March 2022
Last amended—
Point-in-time consolidation · as at 04 February 2022. This page may not reflect amendments made after that date. Confirm the current position against the latest Uganda Gazette before relying on it.
About this Act
A full descriptive summary for this Act has not been recorded yet.
Jurisdiction
Uganda
Type
Principal Legislation
Status
In force
Language
English
Full text of the Act
12 parts ·
11 sections
Enhanced Annotated View adds approved, source-linked propositions, operative requirements, judicial passages, related provisions, amendment notes and authority status. Choose Original PDF to inspect the source consolidation.
Uganda
National Drug Policy and Authority (Fees) Regulations
Commenced on 01 March 2022
[This is the version of this document at 04 February 2022.]
Part 1
FEES FOR REGISTRATION OF DRUGS, RETENTION
1.First registration
(a)
Registration of imported human and veterinary drugs US $2,000 and preparations. (b) Registration of locally manufactured drugs by a large US $200 scale manufacturer. (c) Registration of locally manufactured drugs by a small 150.000 - scale manufacturer. (d) Registration of imported drugs and preparations USS 300 which are repackaged in Uganda, (e) Registration of imported surgical instruments and USS 1,500 appliances. (f) Registration of locally manufactured surgical USS 200 instruments and appliances.
WApproved statute annotation. Statutory quotations are matched to this consolidation and judicial passages are linked to judgments. Check the primary sources alongside this analysis.
What this section does
Governing rule
This section states the governing statutory rule for “First registration”.
“(a) Registration of imported human and veterinary drugs US $2,000 and preparations. (b) Registration of locally manufactured drugs by a large US $200 scale manufacturer. (c) Registration of locally manufactured drugs by a small 150.000 - scale manufacturer. (d) Registration of imported drugs and preparations USS 300 which are repackaged in Uganda, (e) Registration of imported surgical instruments and USS 1,500 appliances. (f) Registration of locally manufactured surgical USS 200 instruments and appliances.”
Primary legislation·Source quotation matched
Practical effect
Use this section as the starting statutory rule for “First registration”, together with the linked provisions and current consolidation.
Deterministic editorial synthesis — not a substitute for the statutory text·Editorial synthesis approved
Elements or requirements
Operative requirements extracted from the consolidated text.
1
(a)Registration of imported human and veterinary drugs US $2,000 and preparations. (b) Registration of locally manufactured drugs by a large US $200 scale manufacturer. (c) Registration of locally manufactured drugs by a small 150.000 - scale manufacturer. (d) Registration of imported drugs and preparations USS 300 which are repackaged in Uganda, (e) Registration of imported surgical instruments and USS 1,500 appliances. (f) Registration of locally manufactured surgical USS 200 instruments and appliances.
Judicial interpretation
Express propositions in source-matched passages from judgments citing this section.
0
No judgment in the current Wakilii corpus expressly cites this section. Bare rule-number references are not assigned where the Order cannot be verified.
Related provisions
No express internal or cross-Act reference appears in this section.
Amendment notes
No section-specific amendment note or instrument-level amendment history appears in this consolidation.
2.Annual retention of registration of drugs and
preparations on register (a) Retention of human and veterinary drugs and USS 500 preparations on the register. (b) Retention of foreign herbal drugs on the register. USS 250 (c) Retention of locally manufactured drugs by a large USS 100 scale manufacturer. (d) Retention of locally manufactured drugs by a small US $ 100 scale manufacturer.
(e)
Retention of imported surgical instruments and USS200 appliances on register. (f) Retention of locally manufactured surgical USS 100 instruments and appliances on register.
WApproved statute annotation. Statutory quotations are matched to this consolidation and judicial passages are linked to judgments. Check the primary sources alongside this analysis.
What this section does
Governing rule
This section states the governing statutory rule for “Annual retention of registration of drugs and”.
“preparations on register (a) Retention of human and veterinary drugs and USS 500 preparations on the register. (b) Retention of foreign herbal drugs on the register. USS 250 (c) Retention of locally manufactured drugs by a large USS 100 scale manufacturer. (d) Retention of locally manufactured drugs by a small US $ 100 scale manufacturer.”
Primary legislation·Source quotation matched
Practical effect
Use this section as the starting statutory rule for “Annual retention of registration of drugs and”, together with the linked provisions and current consolidation.
Deterministic editorial synthesis — not a substitute for the statutory text·Editorial synthesis approved
Elements or requirements
Operative requirements extracted from the consolidated text.
1
(e)Retention of imported surgical instruments and USS200 appliances on register. (f) Retention of locally manufactured surgical USS 100 instruments and appliances on register.
Judicial interpretation
Express propositions in source-matched passages from judgments citing this section.
0
No judgment in the current Wakilii corpus expressly cites this section. Bare rule-number references are not assigned where the Order cannot be verified.
Related provisions
No express internal or cross-Act reference appears in this section.
Amendment notes
No section-specific amendment note or instrument-level amendment history appears in this consolidation.
3.Notification of local herbal drugs and registration
of imported herbal drugs(human and veterinary) (a) Notification of local herbal drugs. 50.000 -
WApproved statute annotation. Statutory quotations are matched to this consolidation and judicial passages are linked to judgments. Check the primary sources alongside this analysis.
What this section does
Governing rule
This section states the governing statutory rule for “Notification of local herbal drugs and registration”.
“of imported herbal drugs(human and veterinary) (a) Notification of local herbal drugs. 50.000 -”
Primary legislation·Source quotation matched
Practical effect
Use this section as the starting statutory rule for “Notification of local herbal drugs and registration”, together with the linked provisions and current consolidation.
Deterministic editorial synthesis — not a substitute for the statutory text·Editorial synthesis approved
Elements or requirements
Operative requirements extracted from the consolidated text.
1
(b)Registration of imported herbal drugs. US $500
Judicial interpretation
Express propositions in source-matched passages from judgments citing this section.
0
No judgment in the current Wakilii corpus expressly cites this section. Bare rule-number references are not assigned where the Order cannot be verified.
Related provisions
No express internal or cross-Act reference appears in this section.
Amendment notes
No section-specific amendment note or instrument-level amendment history appears in this consolidation.
4.Amendment of application for registration of
drugs ( human and veterinary) (a) Major amendment of application for registration of USS 700 imported drugs. (b) Minor amendment of application for registration of USS 400 imported drugs. (c) Amendment of application for notification of USS 100 imported drugs. (d) Major amendment of application for registration of USS 200 locally manufactured drugs. (e) Minor amendment of application for registration of USS 100 locally manufactured drugs. (f) Amendment of application for notification of locally USS 50 manufactured drugs. (g) Major amendment of application for registration of US S 350 imported herbal drugs. (h) Minor amendment of application for registration of US S 200 imported herbal drugs. ((i) Amendment of application for registration of USS 20 imported herbal drugs. (j) Major amendment of application for registration of USS 500 imported surgical instruments and appliances. (k) Minor amendment of application for registration of USS 200 imported surgical instruments and appliances. (1) Notification amendment of application for registration USS 50 of imported surgical instruments and appliances.
WApproved statute annotation. Statutory quotations are matched to this consolidation and judicial passages are linked to judgments. Check the primary sources alongside this analysis.
What this section does
Scope rule
This section defines when and how “Amendment of application for registration of” applies.
“drugs ( human and veterinary) (a) Major amendment of application for registration of USS 700 imported drugs. (b) Minor amendment of application for registration of USS 400 imported drugs. (c) Amendment of application for notification of USS 100 imported drugs. (d) Major amendment of application for registration of USS 200 locally manufactured drugs. (e) Minor amendment of application for registration of USS 100 locally manufactured drugs. (f) Amendment of application for notification of locally USS 50 manufactured…”
Primary legislation·Source quotation matched
Practical effect
Confirm that the matter and forum fall within this section before applying the Act's remaining provisions.
Deterministic editorial synthesis — not a substitute for the statutory text·Editorial synthesis approved
Elements or requirements
Operative requirements extracted from the consolidated text.
0
This section states a single governing proposition and does not enumerate separate elements.
Judicial interpretation
Express propositions in source-matched passages from judgments citing this section.
0
No judgment in the current Wakilii corpus expressly cites this section. Bare rule-number references are not assigned where the Order cannot be verified.
Related provisions
No express internal or cross-Act reference appears in this section.
Amendment notes
No section-specific amendment note or instrument-level amendment history appears in this consolidation.
5.Fees for fast track registration application
(a)
Registration of imported human and veterinary drugs US S 10.000 and preparations.
(b)
Major amendment of application for imported drugs. US$2,100
(c)
Minor amendment of application for imported drugs. USS 1.200
WApproved statute annotation. Statutory quotations are matched to this consolidation and judicial passages are linked to judgments. Check the primary sources alongside this analysis.
What this section does
Scope rule
This section defines when and how “Fees for fast track registration application” applies.
“(a) Registration of imported human and veterinary drugs US S 10.000 and preparations.”
Primary legislation·Source quotation matched
Practical effect
Confirm that the matter and forum fall within this section before applying the Act's remaining provisions.
Deterministic editorial synthesis — not a substitute for the statutory text·Editorial synthesis approved
Elements or requirements
Operative requirements extracted from the consolidated text.
3
(a)Registration of imported human and veterinary drugs US S 10.000 and preparations.
(b)Major amendment of application for imported drugs. US$2,100
(c)Minor amendment of application for imported drugs. USS 1.200
Judicial interpretation
Express propositions in source-matched passages from judgments citing this section.
0
No judgment in the current Wakilii corpus expressly cites this section. Bare rule-number references are not assigned where the Order cannot be verified.
Related provisions
No express internal or cross-Act reference appears in this section.
Amendment notes
No section-specific amendment note or instrument-level amendment history appears in this consolidation.
Part 2
FEES TO BE PAID TO THE AUTHORITY IN RESPECT
Part 3
FEES FOR RETAIL PHARMACIES
Part 5
FEES FOR PHARMACEUTICAL MANUFACTURING
1.Fees for licences for local manufacture
and certificate of suitability of premises No. Licence Application fora licence Application for renewal of a Category licence Application Application Application Application for licence for certificate for licence for certificate of Suitability of Suitability of premises of premises (a) Licence for local manufacture of drugs (i) Licence to manufacture external preparations 2.520.000/- 2.100.000/= 2.100.000' 2.100.000 = or oral liquid preparations. (ii) Licence to manufacture external 2.880.000/= 2.400.000/= 2.400.000- 2.400.000/ - preparations, and oral preparations.
(iii)
Licence to 4 manufacture sterile prepa rations. the preparations in 4.200.000/= 4.200.000/= 3.600.000/= 3.600.000/= para-graphs (i). (ii) and other types of dosage forms. (iv) Approx al of the primary packaging 2.100.000/= 1.800.000/= 1.800.000/= 1.800.000/= activity for the local manufacturer. (v) Approval of the secondary packaging 1.800.000/= 1.500.000/= 1.500.000/= 1.500.000 = activity for the local manufacturer. (xt) Licence to manufacture surgical 4.200.000 4.200.000 = 3.600.000/= 3.600.000/- instruments and appliances.
(b)
Licence for manufacture of herbal drugs (i) Licence to manufacture external 900.000 - 900.000 - 900.000- 900.000 - preparations or oral liquid preparations. (ii) Licence to manufacture external 900.000- 900.000 - 900.000- 900.000. - preparations and oral preparations.
(c)
Licence for manufacture of herbals that comprise class B, Group 1 derivatives
(i)
Licence to manufacture external 2.520.000 = 2.100.000 = 2.100.000 = 2.100.000 = preparations or oral liquid preparations.
(ii)
Licence to manufacture external 2.880.000 = 2.400.000'- 2.400.000 = 2.400.000 - preparations and ora) preparations. (d) Licence for manufacture of class A drugs from cannabis, papaver somniferum. Gatha edulis, cocoa leaf, papaver setigerum and other narcotics.
(i)
Licence for manufacture of raw materials 60.000.000/= 4 5.000.000 = 60.000.000/= 45.000.000 = to be used to manufacture drugs. (ii) Licence to manufacture 30.000.000- 24.000.000 = 30.000.000 = 24.000.000 external or oral preparations. (iii) Licence to l manufacture external 30.000.000. = 30 000.000/= 30.000.000 ■ 30.000.000 preparations and oral preparations. i
(h)
Approval of primarx or secondarx 60.000.000- |S.oou 45.000.000. packaging to be used in (i). (ii) and (iii). ____ J
2.Fees for application to amend condition of manufacturing
licence Application lo amend the conditions manufacturing licence with site m-'pccium I manufacturers in paragraph (a) caieumics ( iM and (iii). (b) Application to amend the conditions of manufacturing licence with site inspection manufacturers paragraph (a), categories (is) and i Application to amend the conditions manufacturing licence for all uii?: <-r paragraph (a), without site inspect ion
Part 6
FEES FOR IMPORTATION AND EXPORTATION OF
250m.( apsi.ie
\ i. Arlen Ul>. ' . •■ w 20 ■! lablei \ ii Ariel i . up: r*' Dre Sus X 111. V . ' ' '
Irimcthoprim 40mg/5ml Suspension xxxv. Surgical Spirit Solution xxxvi I rimcthoprim 80mg Sulfamethoxazole 400mg Tablet xxxvii/ nc Sulfate monohydrate BP (54.90 mg) cquivalent to 20mg elemental Zinc/Solution Supplement IOmg/5ml" Tablets/ Syrup (g) Verification of bulk products of commercial consignment of drugs, where the consignment comprises of the drugs specified 6% of BOB Price in paragraph 6. for primary packaging as part of the local man ufacturing process. (h) Verification of bulk products of commercial consignment of drugs, where the consignment comprises of the drugs specified 10% of BOB Price in paragraph 6. for secondary packaging as part of' the local manufacturing process.
(i)
Verification fees for importation of donations of up to I S S 100.000 = 1000. to non-profit making charities and NGOs d) Verification fees for importation ofdonations of I SS 1001- 200.000'= 5000. to non-profit making charities and'.' NGOs (k) Verification fees for importation ofdonations of over IS S 300.000 = 5000 to non-profit charities and NGOs (1) Verification of imported consignments of unregistered drugs 3.0% of BOB price from authorized and approved sources. (m) Verification of imported consignments for (a) donation for disasters, outbreaks; i
(b)
vaccines; Xil (c) anti-cancer drugs; and (d) pharmaceutical raw materials. (n) Verification of importation of surgical instruments and ap pliances excluding the item in paragraph 19. 2.0% of BOB price
(0)
Verification of a consignment of drugs imported w ithout prior authorization by the Authority, where the consignment arrives 4 0% of 1 OB price at the port of entry before the product is registered: or before amendments to registration arc applied for or arc approved.
<P> Application for annual export permit, for export
I S S50.000 of raw materials from cannabis, papaxer somniferum. Catha cdulis. coca leaf, papaver scligerum and other narcotics.
(q)
Verification of unregistered drugs imported from countries w ilh stringent drug regulator, agencies w here there are reg 12%ofF()d istered alternatives for the drug in Lganda. ir) Verification fees for exportation of drugs and or surgical in 500.000/= struments and surgical appliances.
(s)
Verification of a consignment of examination and surgical 12% of JOB gloves imported for wholesale or retail, from a countrx which is not a member of the LAC.
WApproved statute annotation. Statutory quotations are matched to this consolidation and judicial passages are linked to judgments. Check the primary sources alongside this analysis.
What this section does
Statutory power
This section confers or regulates the statutory power described as “( apsi.ie”.
“\ i. Arlen Ul>. ' . •■ w 20 ■! lablei \ ii Ariel i . up: r*' Dre Sus X 111. V . ' ' '”
Primary legislation·Source quotation matched
Practical effect
The power must be exercised by the authorised decision-maker, within the conditions and purpose stated in the section.
Deterministic editorial synthesis — not a substitute for the statutory text·Editorial synthesis approved
Elements or requirements
Operative requirements extracted from the consolidated text.
5
(i)Verification fees for importation of donations of up to I S S 100.000 = 1000. to non-profit making charities and NGOs d) Verification fees for importation ofdonations of I SS 1001- 200.000'= 5000. to non-profit making charities and'.' NGOs (k) Verification fees for importation ofdonations of over IS S 300.000 = 5000 to non-profit charities and NGOs (1) Verification of imported consignments of unregistered drugs 3.0% of BOB price from authorized and approved sources. (m) Verification of imported consignments for (a) donation for disasters, outbreaks; i
(b)vaccines; Xil (c) anti-cancer drugs; and (d) pharmaceutical raw materials. (n) Verification of importation of surgical instruments and ap pliances excluding the item in paragraph 19. 2.0% of BOB price
(0)Verification of a consignment of drugs imported w ithout prior authorization by the Authority, where the consignment arrives 4 0% of 1 OB price at the port of entry before the product is registered: or before amendments to registration arc applied for or arc approved.
(q)Verification of unregistered drugs imported from countries w ilh stringent drug regulator, agencies w here there are reg 12%ofF()d istered alternatives for the drug in Lganda. ir) Verification fees for exportation of drugs and or surgical in 500.000/= struments and surgical appliances.
(s)Verification of a consignment of examination and surgical 12% of JOB gloves imported for wholesale or retail, from a countrx which is not a member of the LAC.
Judicial interpretation
Express propositions in source-matched passages from judgments citing this section.
0
No judgment in the current Wakilii corpus expressly cites this section. Bare rule-number references are not assigned where the Order cannot be verified.
Related provisions
No express internal or cross-Act reference appears in this section.
Amendment notes
No section-specific amendment note or instrument-level amendment history appears in this consolidation.
Part 7
FEES FOR ANAU SIS OF SAMPLES LN LABORATORY
4.Analysis of samples for foreign herbal products
n Xo. Item Fees per batch
(a)
Anah sis of chemical contaminants US $ 1.050
(b)
Microbial anal}sis US S700 tc) Adulterants US SI000
PARTS- FEESFORINSPECT1ONOFFOREIGNMANUFACTURING PLANTS FOR GOOD MANUFACTURING PRACTICES.
1.Inspection of site for manufacturing drugs
including imported herbal drugs, medical gloves, condoms and surgical instruments and appliances.
Fees for a Fees for Fees for a facility within a facility No. Item facility within Africa, outside outside of EAC the EAC Africa (a) Inspection of manufacturing USS5.000 USS6.O00 USS 8.000 site with all processes at one site for a maximum of 5 product lines for finished pharmaceutical product including biologicals. Inspection of an} additional SI.000 per line S1.500 per USS 2.000 per (b) finished pharmaceutical line line product line. 300% of the 300% of the 300% of the (c) Fast track (IMP inspections inspection fee inspection fee inspection fee
Inspection of sites where the manufacturing process is carried out at other sites within the country where the main site is located.
Fees for a Fees for a Fees for a facil facility within No. Item facility within ity outside of Africa, outside the EAC Africa the EAC
(a)
Inspection of warehous ing of raw materials up to U'S$ 1.500 US$2,000 US$3,000 finished bulk product
(b)
Inspection of sites for final packaging, quality $1,000 USS 1.500 US$2,000 control and final release
(c)
Inspection of sites for quality control and final US$1500 USS2000 USS3.000 release
US $ 5000 per US S 6000 per US $ 7000 per GMP documents evalua (d) manufacturing manufacturing manufacturing tion (desk audits) site site site
Part 9
FEES FOR CLINICAL TRIALS FOR HUMAN DRUGS
Part 10
FEES FOR CLINICAL/ FIELD TRIALS ' FOR
1.Clinical trials or field trials for
imported veterinary drugs and vaccines Item Fees
(H Application to conduct ectoparasiticides field trials US $ 1000
Application for to conduct clinical trial for registered drug (2) USS 1000 and or xaccine Application for to conduct clinical trial for unregistered drug (3) USS 2000 and or vaccine
(4)
Amendment of application US S 200
Clinical trials or field trials for local veterinary drugs and vaccines. 1 t Fees for clinical trials or field Fees for trials for drugs except for locally Item locally manufactured herbal manufactured drugs herbal drugs (1) Application to conduct 1.000.000. USS 1000 ectoparasiticides field trials (2) Application to conduct clinical 1.000.000/= 1.500.000. = trial for registered drug < 3) Application to conduct clinical 1.000.000 = 3.000.000/= trial for unregistered drug (4) Amendment of application 300.000/= 100.000/-
Part 11
FEES FOR CHANGES IN PARTICULARS REGISTERED
Part 12
FEES FOR NATIONAL DRUG AUTHORITY
Part 13
FEES FOR VETTING DRUG PROMOTIONAL
Part 14
FEES FOR DESTRUCTION OF DRUGS
Original Laws of Uganda consolidation (as at 04 February 2022) — public-domain legislation, consolidated by ULII / Laws.Africa (CC BY 4.0). This is a point-in-time text and may not reflect later amendments; confirm against the latest Uganda Gazette before relying on it.
