MINISTRY OF HEALTH

Pharmacy and Poisons Board

SCHEDULE OF FEES FOR

REGULATORY ACTIVITIES

OCTOBER 2023
TABLE OF CONTENTS

1.0 INTRODUCTION ................................................................................. 4

2.0 PROPOSED FEES TO BE LEVIED FOR REGULATORY ACTIVITIES..... 6

2.1 OFFICE OF THE CHIEF EXECUTIVE OFFICER ............................... 6

2.1.1 Trade Affairs Function ..................................................................... 6

2.1.2 Supply Chain Department ............................................................... 6

2.1.3 Planning, QMS, Research and Development Department ................. 6

2.2 MEDICAL PRODUCTS AND HEALTH TECHNOLOGIES DIRECTORATE

6
2.2.1 Product Evaluation and Registration Department....................... 6
2.2.1.1 Medical Products Division ....................................................... 6
2.2.1.2 Health Technologies Division .................................................. 7
2.2.2 Product Safety Department ........................................................ 9
2.2.2.1 Clinical Trials Division ............................................................ 9
2.2.2.2 Pharmacovigilance & Post-Market Surveillance Division .......... 9
2.2.2.3 Medicines Information & Resource Centre Division ................. 9
2.2.3 Inspectorate and Surveillance Department ............................... 10
2.2.3.1 Good Manufacturing Practices Division ................................. 10
2.2.3.2 Inspectorate and Enforcement Division (Good Distribution
Practices) ......................................................................................... 11

2.3 LABORATORY SERVICES DIRECTORATE...................................... 12

2.3.1 Quality Control Laboratory Department ................................... 12
Wet Chemistry.................................................................................. 12
Medical Devices ................................................................................ 13
Biological Analysis ............................................................................ 13
Testing Summary – Sample Type (Per Batch ..................................... 13

2.4 PHARMACY PRACTICE DIRECTORATE.......................................... 14

2.4.1 Licensing and Good Pharmacy Practice Department ................. 14
2.4.2 Training and Professional Development Department ................ 14

Page 2 of 18
3.0 COMPARATIVE ANALYSIS OF REGULATORY FEES LEVIED IN OTHER
JURISDICTIONS ....................................................................................... 16

3.1 REPUBLIC OF UGANDA: ............................................................... 16

3.2 REPUBLIC OF TANZANIA .............................................................. 17

3.3 REPUBLIC OF GHANA ................................................................... 18

Page 3 of 18
1.0 INTRODUCTION

The Pharmacy and Poisons Board (PPB) is established under the Pharmacy
and Poisons Act (CAP 244). The Pharmacy and Poisons Act provides for the
control of the profession of pharmacy and the trade in drugs and poisons
through the Pharmacy and Poisons Board.

The Cap 244 has been amended severally over the years to accommodate new
challenges that arise from expanding regulation of the pharmaceutical
industry. Control of products now includes products such as medical devices,
nutritional supplements, cosmetics, vaccines, blood products and herbal
products. The regulatory activities have also been expanded to include
transportation of pharmaceuticals, safe disposal of pharmaceutical waste,
batch/lot release among others. The Pharmacy profession now covers
pharmacists, pharmaceutical technologists, pharmacy specialists,
pharmaceutical representatives and the regulation of pharmacy training.

The amendments, however have not adequately addressed the expanding

mandate in terms of fees charged for services rendered and penalties meted
out to offenders. The PPB levies fees for services rendered in executing its
mandate of regulating the profession of pharmacy and ensuring the safety,
quality and efficacy of medical products and health technologies. These fees
are gazetted by the Cabinet Secretary for Health according to Section 44 of
the Pharmacy and Poisons Act, which gazettement was last done in 2010.

Consequently, the expanding regulatory scope and capacity has strained PPB
resources and worn thin the revenue base. As such there is an urgent need
to expand our revenue base to meet current regulatory resource needs and
ensure sustainability of providing quality services.

Additionally, in compliance with the recommendations of the World Health

Organization Global Benchmarking Tool (WHO-GBT), the PPB, as the National
Regulatory Authority is required to have sustainable funding to perform its
regulatory functions under stable conditions and have authority to manage
the funds generated internally to finance regulatory activities. As such it was
recommended that the PPB obtains additional resources to ensure sufficiency
of revenue to perform regulatory activities. This is in addition to the
requirement to develop provisions relating to reduction or exemption of dues,
taxes, tariffs or fees in defined situations for public health interest.

For these reasons, the PPB, is in the process of revising its fees in order to
keep up with the continuing increase in costs of services as well as the
technology used in ensuring the provision of quality services. Further, there

Page 4 of 18
is need to be in line with charges across the EAC region to aid in the ongoing
harmonization initiatives.

The paper is structured based on the different services provided by the

Directorates and Departments of the PPB.

Page 5 of 18
2.0 PROPOSED FEES TO BE LEVIED FOR REGULATORY ACTIVITIES

The PPB is empowered under Section 3A (g) of the Pharmacy and Poisons Act
to levy, collect and utilize fees for services rendered. The proposals below seek
to ensure that all services rendered by the PPB are included in the Schedule
of Fees per directorate as follows:

2.1 OFFICE OF THE CHIEF EXECUTIVE OFFICER

Purpose of Fees Current Fee Proposed Fee

(USD) (USD)
2.1.1 Trade Affairs Function

1. Import Permit Fee 2% is the Gazetted Fee 2% FOB

0.75% Freight on Board

(FOB) is currently charged
upon execution of an out of
court Deed of settlement on
17th May 2011

2.1.2 Supply Chain Department

2. Stamping Documents for Tenders - Kshs 20. Per

page
2.1.3 Planning, QMS, Research and Development Department

3. Data mining for an external operational - 5,000

research per study from a partner

2.2 MEDICAL PRODUCTS AND HEALTH TECHNOLOGIES

DIRECTORATE

2.2.1 Product Evaluation and Registration Department

Purpose of Fees Current Fee Proposed Fee

(USD) (USD)
2.2.1.1 Medical Products Division

1. Application for registration of health products not 1,000 3500

manufactured in Kenya.
2. Application for registration of health products 500 1,000
manufactured in Kenya.
3. Application for renewal of registration of health products 1,000 2,000
not manufactured in Kenya.
4. Application for renewal of registration of health products 500 1,000
manufactured in Kenya.
5. Application for Variation: not Manufactured in Kenya-
Major Variation 300 1,000
Minor Variation 300 300

Page 6 of 18
 Purpose of Fees Current Fee Proposed Fee
(USD) (USD)
Notification 300 300
Safety Updates - 300
6. Application for Variation: not Manufactured in Kenya-
(Abridged Pathway):
Major Variation 300 500
Minor Variation 300 300
Notification 300 300
Safety Updates - 300
7. Application for Variation: not Manufactured in Kenya
(Locally Manufactured)
Major Variation 300 500
Minor Variation 300 300
Notification 300 300
Safety Updates - 300
8. Application for Fast tracking Evaluation of applications 2,000 5000
for Health product not manufactured in Kenya

9. Application for Fast tracking evaluation of application for 2000 3000

health product manufactured in Kenya
10. Application for donated health products - Exempt

2.2.1.2 Health Technologies Division

11. Application for Issuance of Emergency Use Authorization 2,500 3,000

for a Medical Devices and In-Vitro Diagnostic
12. Application for Issuance of Emergency Use Authorization - 1000
for a Medical Devices and In-Vitro Diagnostic for
research use only
13. Application for registration of Class A Medical Device 100 350
14. Application for registration of Class B Medical Device 200 500
15. Application for registration of Class C Medical Device 1,000 2,000
16. Application for registration Class D Medical Device 1,000 3,500
17. Application for renewal of a Class A Medical Device 100 200
18. Application for renewal of a Class B Medical Device 200 300
19. Application for renewal of a Class C Medical Device 1,000 1,000
20. Application for renewal of a Class D Medical Device 1,000 1,000
21. Application for Abridged Pathway for Class B Medical - 3,500
devices and IVDs
22. Application for Expedited Class B Medical devices and - 5,000
IVDs Registration
23. Application for Immediate Class B Medical devices and - 7,000
IVDs Registration Evaluation Route
24. Application for Abridged Evaluation Route Class C - 4,500
Medical devices and IVDs Registration
25. Application for Expedited Evaluation Route Class C - 10,000
Medical devices and IVDs Registration

Page 7 of 18
 Purpose of Fees Current Fee Proposed Fee
(USD) (USD)
26. Application for Change notification of Medical devices
and IVDs - Change notifications types per class of
Medical devices:

Class A (Review changes, administrative changes and - 50

notification)
Class B (Review changes, administrative changes and - 100
notification)
Class C (Technical changes, administrative changes and - 300
notifications)
Class D (Technical changes, administrative changes and - 500
notifications)
27. Application for Expedited Class D Medical devices and - 5,000
IVDs Registration (EDR)
28. Application for registration of health products not 500 500
manufactured in Kenya. (Food Supplement, Cosmetics
and Borderline Products)
29. Application for registration of health products 100 200
manufactured in Kenya. (Food Supplement, Cosmetics
and Borderline Products)
30. Application for renewal of registration of health products 500 500
not manufactured in Kenya. (Food Supplement,
Cosmetics and Borderline Products)
31. Application for retention of health products not 300 400
manufactured in Kenya

32. Application for retention of health products 150 200

manufactured locally

33. Application for Variation on (Food Supplement, - 150

Cosmetics and Borderline Products)

34. Application for Retention on (Food Supplement, - 200

Cosmetics and Borderline Products) not Manufactured
in Kenya
35. Application for Retention on (Food Supplement, - 100
Cosmetics and Borderline Products) Manufactured in
Kenya
36. Application for renewal of registration of health products 100 200
manufactured in Kenya. (Food Supplement, Cosmetics
and Borderline Products)
37. Application for registration of health product 50 50
(Traditional Health Products – Locally Manufactured)
38. Application for renewal of registration/listing of health 20 20
products (Traditional Health Products – Locally
Manufactured)
39. Application for review of Certificate of Pharmaceutical - Ksh.2000
Product (COPP)
40. Application for Authorization of Unregistered HPT - 500

Page 8 of 18
 Purpose of Fees Current Fee Proposed Fee
(USD) (USD)
41. Application for Compassionate use - Exempt

42. Application for certificate of parallel importation - Kshs.30,000

43. Application for renewal of certificate of parallel - Kshs.30,000

importation
44. Application fee for a new parallel import license - 1000

45. Appeal of rejected application for parallel import license - 300

46. Application for renewal of parallel import license - 500

2.2.2 Product Safety Department

Purpose of Fees Current Fee Proposed Fee

(USD) (USD)
2.2.2.1 Clinical Trials Division

1. Application for conduct of clinical trials (Industry 1,000 10,000

funded)
2. Application for conduct of clinical trials (Investigator/ 1,000 5,000
local Research Institution funded)
3. Application for conduct of clinical trials (Academic 1,000 1,500
research)
4. Application for review of clinical trial protocol - 1,000
Amendments
5. Clinical Trials Sites Inspection (Local) - 3,000

2.2.2.2 Pharmacovigilance & Post-Market Surveillance Division

6. Pharmacovigilance Inspection fees - 1,000

7. Qualified Person for Pharmacovigilance Training Course - 2,000

8. Review of PSURs/PBRERs - 1,000

9. Cost of publication of a recall class 1 - 2,000

2.2.2.3 Medicines Information & Resource Centre Division

10. Application fee for review of rescheduling of foreign - 1,500
manufactured products
11. Application fee for review of rescheduling of locally - 1,000
manufactured products
12. Application fee for advertising on Billboards and 35 100
Television
13. Application fee for Advertising/promotion on Immobile 35 100
branded items
14. Penalties for non-approved advertisement and - 1,000
promotions

Page 9 of 18
 Purpose of Fees Current Fee Proposed Fee
(USD) (USD)
15. Advertisement per product per advert per media 50 100

2.2.3 Inspectorate and Surveillance Department

The Current fees charged under the Good Manufacturing Practices Division
are two-pronged i.e
Good Manufacturing Practice Audit per site -
a. Foreign Manufacturing Site – USD 4000
b. Local Manufacturing site – USD 1,000

Therefore, owing to the unique nature of GMP audits, see below the proposed
fees in line with the specific tasks to be carried out under the GMP audits:
Purpose of Fees Proposed Fee Proposed Fee Proposed Fee (USD)
(USD) (USD)

Within Kenya Within Africa Outside Africa

(Asia/Europe/Ameri
ca/New
Zealand/Australia)

2.2.3.1 Good Manufacturing Practices Division

1. Inspection of General products 2,000 6,000 8,000

manufacturing site with all
processes at one site for a
maximum of 5 product lines for
finished pharmaceutical
products including biologicals.
2. Inspection of Penicillin products 2,000 6,000 8,000
manufacturing site with all
processes at one site for a
maximum of 5 product lines for
finished pharmaceutical
products
3. Inspection of Cephalosporin 2,000 6,000 8,000
products manufacturing site
with all processes at one site for
a maximum of 5 product lines
for finished pharmaceutical
products.
4. Inspection of Hormone products 2,000 6,000 8,000
manufacturing site with all
processes at one site for a
maximum of 5 product lines for
finished pharmaceutical
products
5. Inspection of Cytotoxic products 2,000 6,000 8,000
manufacturing site with all
processes at one site for a
maximum of 5 product lines for

Page 10 of 18
 Purpose of Fees Proposed Fee Proposed Fee Proposed Fee (USD)
(USD) (USD)

Within Kenya Within Africa Outside Africa

(Asia/Europe/Ameri
ca/New
Zealand/Australia)
finished pharmaceutical
products
6. Inspection of Blood products 2,000 6,000 8,000
manufacturing site with all
processes at one site for a
maximum of 5 product lines for
finished pharmaceutical
products
7. Inspection of any additional 500 1,000 per line 2,000 per line
production line

8. Inspection of sites for final 1,000 2,000 4,000

Primary packaging, quality
control and final release
9. Inspection of sites for final 1,000 2,000 4,000
Secondary packaging, quality
control and final release
10. GMP off-site inspection - 4,000 8,000
(Document Review Audits)
11. Inspection of warehousing 2,000 2,000 4,000
facility
12. Site Variation 2,000 6,000 8,000

13. Special Inspection/Concise 2,000 6,000 8,000

Inspection
14. Fast Track Audits 100% of 200% of 200% of nominal fee
nominal fee nominal fee
15. CRO (Contract Clinical 2,000 6,000 8,000
Research Organization)
2.2.3.2 Inspectorate and Enforcement Division (Good Distribution Practices)

1. Pharmaceutical Waste Disposal Kshs. 5,000 - -

per application
2.

3.

Page 11 of 18
 2.3 LABORATORY SERVICES DIRECTORATE
2.3.1 Quality Control Laboratory Department
Current Fees Proposed Fees
(USD) (USD)
Purpose of Fees - Tests

Wet Chemistry
1. Uniformity of weight/volume: 25.00 50
Tablets

Capsules/Vials/Sachets 40.00 60
2. Uniformity of content
By HPLC 410.00 500
By UV 235.00 400
By Titration 285.00 400

3. Identification Only
By HPLC 355.00 500
By FTIR 200.00 250
By TLC 140.00 200
By UV 195.00 250
By Titration 250.00 300

4. Identification followed by
Assay – HPLC 424.00 500
Assay – UV 315.00 400
Assay - Titration 395.00 450

5. Dissolution and Identification by 440.00 500

HPLC/UV/Titration
Each additional component
205.00 300

6. Assay – HPLC 355.00 400

Assay – UV 195.00 250
Assay - Titration 250.00 300
Assay – AAS 430.00 500
Each additional component (includes after day x 165.00 200
preparations)

7. Related substances/impurites 180.00 230

8. Water content 325.00 400

9. pH 25.00 50

10. Melting point 40.00 80

11. Friability 50.00 50

Page 12 of 18
 Current Fees Proposed Fees
(USD) (USD)
Purpose of Fees - Tests

12. Disintegration 55.00 80

13. Optical Rotation 55.00 80

Medical Devices
14. Male Latex Condoms – Lubricant test 445.00 500
15. Male Latex Condoms – Inflation test (Burst 500 500
Volume/Pressure)
16. Male Latex Condoms – Conductivity test 450 450
(Freedom from holes)

17. Male Latex Condoms – Dimensions (Thickness) 220 250

18. Male Latex Condoms – Dimensions (Length) 220 250

19. Male Latex Condoms – Dimensions (Width) 220 250

20. Visual Leak test 250 250

21. Wet package integrity test 250 250

22. Surgical gloves – Dimensions (Thickness) 190 250

23. Surgical gloves – Dimensions (Length) 175 250

24. Surgical gloves – Dimensions (Width) 175 250

Biological Analysis
25. Sterility Testing 755.00 755

26. Microbial Contamination of non-sterile products 355.00 355

27. Bacterial Endotoxin test 515.00 515

28. Microbial Assay 410.00 410

29. Preservative Efficacy 390.00 390

Testing Summary – Sample Type (Per Batch

30. Tablet - 1000
31. Sterile preparations (Injections, I.V. Fluids) - 1400
32. Oral Solutions - Syrups/Suspensions - 1150

33. Medical Devices - IVDs - 1400

34. Medical Devices – Gloves, Condoms, Needles and - 2000
Syringes)

Page 13 of 18
 2.4 PHARMACY PRACTICE DIRECTORATE
2.4.1 Licensing and Good Pharmacy Practice Department

Purpose of Fees Current Fee Proposed Fee

(KSH) (KSH)
1. Annual Practice License for a pharmacist/ 5,000 10,000
pharmaceutical technologist
2. Internship Temporary License - 3,000

3. Temporary license for foreign health professionals - 30,000

4. Application for recognition as a specialist pharmacist - 20,000

5. Registration of Premises 10,000 15,000

6. Wholesale dealer’s license 30,000 50,000

7. License to deal in mining, agricultural and 5,000 10,000

horticultural poisons
8. License to sell Part II poisons 5,000 10,000

9. License to manufacture drugs per product 5,000

10. Pharmaceutical Representative Permit 5,000 10,000

11. Manufacturing License 50,000 150,000

12. Certification/verification of documents 1,000 10,000

2.4.2 Training and Professional Development Department

Purpose of Fees Current Fee Proposed Fee
(KSH) (KSH)
1. Certificate of Registration as a 5,000 10,000
pharmacist/pharmaceutical technologist
2. Restoration of name to register/ Roll 5,000 10,000

3. Training and Assessment/Evaluation fees for

pharmacists and pharmaceutical technologists
Stage/Level I:

Kenyan Citizens 9,500

Foreigners 22,000 30,000
4. Training and Assessment/Evaluation fees for
pharmacists and pharmaceutical technologists
Stage/Level II:

Kenyan Citizens 7,000

Foreign Citizens 20,000 30,000
5. New application, inspection and Course Approval fees
for pharmacy training institutions:

a. Degree programmes 400,000 400,000

b. Diploma Programmes 210,000 210,000

Page 14 of 18
 Purpose of Fees Current Fee Proposed Fee
(KSH) (KSH)
6. Renewal of Annual Course approval fees:

a. Degree Programme 60,000 60,000

b. Diploma Programme 30,000 30,000

7. Indexing of Students in the pharmacy training 5,000
institutions in Kenya:

a. Degree programme 1,000

5,000
b. Diploma programme 1,000
8. Indexing of foreign students - 20,000
9. Application for Accreditation as a Continuing 22,000 22,000
Professional Development (CPD) Provider
10. Annual Accreditation fee - 20,000

11. Application for recognition as a Specialist Pharmacist - 10,000

12. Annual Retention as a Specialist Pharmacist - 10,000

13. Penalty for late renewal of annual practice - 10% of the

license/premise license/ wholesale dealers license/ normal
manufacturing license/pharmaceutical representative applicable fees
permits of the fees
charged on
monthly
incremental
(accrual)basis
up to a
maximum of
the full annual
fees
14. Change of ownership of a pharmacy, relocation) - 15,000

15. Relocation of a pharmacy - 15,000

16. Replacement of lost, spoiled, defaced certificate of 1,000 10,000

registration or certificate of enrolment (Issuing of a
duplicate certificate)
17. Issuing of a letter/ certificate of good professional 1,000 10,000
standing
18. Follow-up inspection for training institutions - 50,000

19. Replacement of lost premises identification code - 1,000

20. Pre-registration inspection of premises (wholesale, - 10,000

retail, hospital)
21. Variation (termination of contract) - 5,000

22. Variation (closure of business) - 5,000

23. Provision of licensing data (premise and professional) - 10,000

24. Application for re-marking of exams - 20,000

Page 15 of 18
3.0 COMPARATIVE ANALYSIS OF REGULATORY FEES LEVIED IN
OTHER JURISDICTIONS

3.1 REPUBLIC OF UGANDA:

FEE STRUCTURES FOR GOOD MANUFACTURING PARACTICES FOR FOREIGN

MANUFACTURING

Processes at the Within East Within the rest Outside Africa

site Africa of Africa (Asia/Europe/America/New
Zealand/Australia)

Inspection of US$5,000 US$6,000 US$8,000

manufacturing site
with all processes at
one site for 5 product
lines

Fee for inspection of $ 1,000 per $ 1,500 per line $ 2,000 per line
any additional line
production line

Fees for inspection of sites where the manufacturing process is carried out in more
than one site in the country where the main site is located

Inspection of US $1,500 US$2,000 US$3,000

warehousing of raw
materials up to
finished bulk
product

Inspection of sites US$1,000 US$1,500 US$2,000

for final packaging,
quality control and
final release

Inspection of sites US$500 US$750 US$1,000

for quality control
and final release

Fees for GMP US $ 5000 per US $ 6,000 per US $ 7,000 per

documents manufacturing site manufacturing site manufacturing site
evaluation (Desk
Audits)

Page 16 of 18
 Stage of clinical trial US $

1. Application to undertake clinical trial for a registered drug 2,500

2. Application to undertake clinical trial for unregistered drug 4,000

3. Application to amend clinical trial application 200

3.2 REPUBLIC OF TANZANIA

GMP Inspection fee per block (Domestic)

GMP Inspection -domestic Pharmaceutical - USD 250

new sites

GMP inspection fee for facilities of food, pharmaceuticals and medical devices per
block (Foreign)

East Africa USD 4,000

Southern Africa Development Community USD 4,500

(SADC) Countries

Rest of Africa USD 5,000

Asia USD 6,000

Europe USD 6,500

America USD 7,500

Australia and New Zealand USD 7,500

Type of application USD

1. Application to conduct clinical trials 3,000

2. Amendments clinical trials-Major 300

3. Amendments clinical trials-Minor 300

4. Fast track for clinical trial application Double the cost of registration and analysis fee

Page 17 of 18
3.3 REPUBLIC OF GHANA

Type of application – Clinical

APPROVED RATES (USD)
Trials
1. Industry Funded (Phase I) 15,000.00

2. Industry Funded (Phase II) 12,000.00 -

3. Industry Funded (Phase III) 10,000.00 -

4. Investigator / Local Phase 3&4 7,000.00 -

5. Research Institution Funded (Ghana) 5,000.00 -

6. Amendment To Clinical Trial Protocol 1,000.00 -

7. Academic Research Trial (Individual) 2,000.00

Page 18 of 18