National Drug Policy and Authority (Fees) (Amendment) Regulations

1. Citation

These Regulations may be cited as the National Drug Policy and Authority (Fees) (Amendment) Regulations,

Section analysis Source-linked statutory analysis Source linked

Approved 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 “Citation”.

“These Regulations may be cited as the National Drug Policy and Authority (Fees) (Amendment) Regulations,”

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.

These Regulations may be cited as the National Drug Policy and Authority (Fees) (Amendment) Regulations,

Judicial interpretation

Express propositions in source-matched passages from judgments citing this section.

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. Amendment of S.I. No. 67 of

2025 The Schedule to the National Drug Policy and Authority (Fees) Regulations, 2025 is amended-

(a)

in Part 1, item 3 (f) by substituting "(f) Notification of amendment of application for imported drugs" with, "(f) Notification of amendment of application for locally manufactured drugs";

(b)

in Part 5-

item 3 by substituting "3. Fees for the manufacture of bulk sterile and non-sterile pharmaceutical products" with, "3. Fees for the manufacture of bulk and intermediate sterile and non-sterile pharmaceutical products";

item 3 (b) by substituting "(b) Licence to manufacture bulk products" with "(b) Licence to manufacture bulk or intermediate products";

item 3 (c) by substituting "(c) Licence to conduct quality control testing activities for bulk sterile and non-sterile pharmaceutical products" with "(c) Licence to conduct quality control activities for sterile and non-sterile pharmaceutical products";

(c)

in Part 6-

paragraph (c) by substituting "(c) Verification of consignment of donations and grants imported for projects and programmes of commercial organisations and Government Ministries, departments and institutions" with, "(c) Verification of consignment of registered drugs other than drugs specified in paragraphs (f) and (p) and verification of consignment of registered drugs imported for donation or as a grant or for a project or programme of a Government Ministry, department or institution";

by inserting immediately after paragraph (f) the following-

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"(fa) Verification of consignment of | 15% of

imported drugs frém a country which is |} FOB not a Partner State of the East African | price" Community where the consignment comprises drugs in paragraph (f) and where the importation is for a project or programme of a Government Ministry, department or institution

(iii)

paragraph (h) by substituting the fee with "15% of FOB price"; (iv) paragraph (0) by substituting the word "primary" with the word "secondary"; and in Part 7- (i) _ by substituting for item 1, the following- "1. Examination of drugs by the Authority in the course of performance of its functions (except cannabis and imported herbal drugs) Test Fees per batch (a) | Testing of samples of local drug products (three batches) for purpose of registration; single ingredient- (i)) where the Authority provides the 5,700,000/= inputs (ii)) where the manufacturer provides the 1,900,000/= Inputs (b) | Testing of samples of local drug products for purposes of registration; for any 1,900,000/- additional ingredient

Testing of samples of local drug products (three batches) for purpose of registration, where the samples are manufactured after failure of test in paragraph (a) or (b), respectively

USD$ 6,000

Testing of samples of imported drug products (three batches) for purpose of registration; single ingredient

22,800,000/-

Testing of samples of imported drug products for purposes of registration; for any additional ingredient

5,700,000/=

Testing of local drug products after registration

USD$ 300

Testing of imported drug products after registration

USD$ 1,500

Re-testing of sample of drug product at the request of owner, manufacturer, importer or any other person

$10,000

Testing of drug product by the Authority in laboratory not owned by the Authority

Cost for testing + 10% of the cost

by substituting for item 4 D, the following)-

D. Other services

Test for product classification

USD$ 100

HON. DR. ACENG JANE RUTH OCERO Minister of Health.