National Drug Policy and Authority (Suitability of Premises) Regulations

1. Title

These Regulations may be cited as the National Drug Policy and Authority (Suitability of Premises) Regulations, 2014.

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 “Title”.

“These Regulations may be cited as the National Drug Policy and Authority (Suitability of Premises) Regulations, 2014.”

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.

1

These Regulations may be cited as the National Drug Policy and Authority (Suitability of Premises) Regulations, 2014.

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. Interpretation

In these Regulations, unless the context otherwise requires- "Act" means the National Drug Policy and Authority Act, Cap. 206; "Authority" means the National Drug Authority; "inspecting officer" means a person empowered under Part VII of the Act to enter any premises; "licensed person" means a person licensed under section 14 of the Act; "licensed seller" means a person licensed under section 15 of the Act.

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

Definition

This section supplies the definitions or statutory meaning governing “Interpretation”.

“In these Regulations, unless the context otherwise requires- "Act" means the National Drug Policy and Authority Act, Cap. 206; "Authority" means the National Drug Authority; "inspecting officer" means a person empowered under Part VII of the Act to enter any premises; "licensed person" means a person licensed under section 14 of the Act; "licensed seller" means a person licensed under section 15 of the Act.”

Primary legislation Source quotation matched

Practical effect

Use this definition when interpreting other provisions that employ the language addressed by “Interpretation”.

Deterministic editorial synthesis — not a substitute for the statutory text Editorial synthesis approved

Elements or requirements

Operative requirements extracted from the consolidated text.

1

In these Regulations, unless the context otherwise requires- "Act" means the National Drug Policy and Authority Act, Cap. 206; "Authority" means the National Drug Authority; "inspecting officer" means a person empowered under Part VII of the Act to enter any premises; "licensed person" means a person licensed under section 14 of the Act; "licensed seller" means a person licensed under section 15 of the Act.

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

Section 14 · Storage areas Section 15 · Materials to be protected against light National Drug Policy and Authority Act

Amendment notes

No section-specific amendment note or instrument-level amendment history appears in this consolidation.

3. Approval of location by the Authority

A person who wishes to apply for a certificate of suitability of premises shall, prior to the application, seek an approval of the proposed location

of the premises from the Authority.

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 “Approval of location by the Authority”.

“A person who wishes to apply for a certificate of suitability of premises shall, prior to the application, seek an approval of the proposed location”

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.

1

A person who wishes to apply for a certificate of suitability of premises shall, prior to the application, seek an approval of the proposed location

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. Certificate of suitability of premises

(1)

A person shall not conduct the business of manufacturing, wholesale, retail of drugs or operate as a licensed seller, without a certificate of suitability of premises issued by the Authority, in respect of the premises where the business is to be conducted. (2) The Authority shall issue a general certificate of suitability of premises, for premises to be used for manufacturing drugs and for wholesale and retail pharmacies and a limited certificate of suitability of premises, for premises to be used by a licensed seller.

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 “Certificate of suitability of premises”.

“(1) A person shall not conduct the business of manufacturing, wholesale, retail of drugs or operate as a licensed seller, without a certificate of suitability of premises issued by the Authority, in respect of the premises where the business is to be conducted. (2) The Authority shall issue a general certificate of suitability of premises, for premises to be used for manufacturing drugs and for wholesale and retail pharmacies and a limited certificate of suitability of premises, for premises to be used by a…”

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.

1

(1) A person shall not conduct the business of manufacturing, wholesale, retail of drugs or operate as a licensed seller, without a certificate of suitability of premises issued by the Authority, in respect of the premises where the business is to be conducted. (2) The Authority shall issue a general certificate of suitability of premises, for premises to be used for manufacturing drugs and for wholesale and retail pharmacies and a limited certificate of suitability of premises, for premises to be used by a licensed seller.

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. Application for certificate of suitability of premises

(1)

A person who wishes to conduct the business of manufacturing, wholesale, retail of drugs or to operate as a licensed seller, shall make an application for a certificate of suitability of premises, in respect of the premises where the business is to be conducted. (2) An application for a certificate of suitability of premises for premises to be used to manufacture drugs or for premises for wholesale or retail pharmacies shall be accompanied by the name and qualifications of the pharmacist who is to supervise the operations at the premises and the prescribed fees. (3) An application for a certificate of suitability of premises shall be accompanied by- (a) the plan of the premises; or (b) where buildings are to be constructed, the plans of the buildings. (4) An application for a certificate of suitability of premises shall be made using Forms 9, 10, 11 and 12, in the Schedule to these Regulations, for manufacturing of drugs, wholesale pharmacy, retail pharmacy or for operating as a licensed seller, respectively.

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

Scope rule

This section defines when and how “Application for certificate of suitability of premises” applies.

“(1) A person who wishes to conduct the business of manufacturing, wholesale, retail of drugs or to operate as a licensed seller, shall make an application for a certificate of suitability of premises, in respect of the premises where the business is to be conducted. (2) An application for a certificate of suitability of premises for premises to be used to manufacture drugs or for premises for wholesale or retail pharmacies shall be accompanied by the name and qualifications of the pharmacist who is to supervise…”

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.

1

(1) A person who wishes to conduct the business of manufacturing, wholesale, retail of drugs or to operate as a licensed seller, shall make an application for a certificate of suitability of premises, in respect of the premises where the business is to be conducted. (2) An application for a certificate of suitability of premises for premises to be used to manufacture drugs or for premises for wholesale or retail pharmacies shall be accompanied by the name and qualifications of the pharmacist who is to supervise the operations at the premises and the prescribed fees. (3) An application for a certificate of suitability of premises shall be accompanied by- (a) the plan of the premises; or (b) where buildings are to be constructed, the plans of the buildings. (4) An application for a certificate of suitability of premises shall be made using Forms 9, 10, 11 and 12, in the Schedule to these Regulations, for manufacturing of drugs, wholesale pharmacy, retail pharmacy or for operating as a licensed seller, respectively.

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.

6. Inspection of premises

(1)

The Authority shall, prior to issuing a certificate of suitability of premises, inspect the premises to determine that the premises are suitable for the purpose for which the certificate is to be issued. (2) The inspecting officer who inspects premises under this Regulation shall make a report, in the format prescribed in Forms 13, 14 or 15 in the Schedule to these Regulations, for wholesale pharmacy, retail pharmacy and Class C drug shop, respectively.

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 “Inspection of premises”.

“(1) The Authority shall, prior to issuing a certificate of suitability of premises, inspect the premises to determine that the premises are”

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.

1

(1) The Authority shall, prior to issuing a certificate of suitability of premises, inspect the premises to determine that the premises are suitable for the purpose for which the certificate is to be issued. (2) The inspecting officer who inspects premises under this Regulation shall make a report, in the format prescribed in Forms 13, 14 or 15 in the Schedule to these Regulations, for wholesale pharmacy, retail pharmacy and Class C drug shop, respectively.

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.

7. Suitability of premises

The standards of suitability of premises provided in Parts II, III and IV of these Regulations shall be the minimum standards of suitability of premises required under the law.

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

Mandatory duty

This section imposes mandatory requirements concerning “Suitability of premises”.

“The standards of suitability of premises provided in Parts II, III and IV of these Regulations shall be the minimum standards of suitability of premises required under the law.”

Primary legislation Source quotation matched

Practical effect

The provision uses mandatory language; the responsible person or institution should be able to demonstrate compliance.

Deterministic editorial synthesis — not a substitute for the statutory text Editorial synthesis approved

Elements or requirements

Operative requirements extracted from the consolidated text.

1

The standards of suitability of premises provided in Parts II, III and IV of these Regulations shall be the minimum standards of suitability of premises required under the law.

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.

8. Location of premises

The premises shall be located in a place where the premises cannot be contaminated from the external environment or other activities.

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

Mandatory duty

This section imposes mandatory requirements concerning “Location of premises”.

“The premises shall be located in a place where the premises cannot be contaminated from the external environment or other activities.”

Primary legislation Source quotation matched

Practical effect

The provision uses mandatory language; the responsible person or institution should be able to demonstrate compliance.

Deterministic editorial synthesis — not a substitute for the statutory text Editorial synthesis approved

Elements or requirements

Operative requirements extracted from the consolidated text.

1

The premises shall be located in a place where the premises cannot be contaminated from the external environment or other activities.

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.

9. Standards of construction

The premises shall- (a) be of a permanent nature; (b) be protected against, adverse weather conditions including dust, ground water seepage, vermin and pest infestation; (c) have sufficient space for the carrying out and supervision of the necessary operations; (d) have air intakes, exhausts, and associated pipe work and trucking sited so as to avoid contamination; (e) have the plumbing, electrical, ventilation and other services in the manufacturing and processing areas sited in a way that creates ease of cleaning and shall for this purpose run outside the processing and manufacturing areas and be well sealed in place;

(f)

have drains that are of an adequate size and that are provided with sufficient traps and proper ventilation; (g) have well marked fire exits and the access to the fire exists kept clear at all times; (h) have floors and walls made of a washable and impervious material with a flat surface free of cracks and a ceiling covered with a nonflaking finish that allows easy cleaning; and (i) be well lit, ventilated and have appropriate air-control facilities including temperature, humidity, and filtration for the operations to be undertaken.

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

Mandatory duty

This section imposes mandatory requirements concerning “Standards of construction”.

“The premises shall- (a) be of a permanent nature; (b) be protected against, adverse weather conditions including dust, ground water seepage, vermin and pest infestation; (c) have sufficient space for the carrying out and supervision of the necessary operations; (d) have air intakes, exhausts, and associated pipe work and trucking sited so as to avoid contamination; (e) have the plumbing, electrical, ventilation and other services in the manufacturing and processing areas sited in a way that creates ease of…”

Primary legislation Source quotation matched

Practical effect

The provision uses mandatory language; the responsible person or institution should be able to demonstrate compliance.

Deterministic editorial synthesis — not a substitute for the statutory text Editorial synthesis approved

Elements or requirements

Operative requirements extracted from the consolidated text.

1

(f) have drains that are of an adequate size and that are provided with sufficient traps and proper ventilation; (g) have well marked fire exits and the access to the fire exists kept clear at all times; (h) have floors and walls made of a washable and impervious material with a flat surface free of cracks and a ceiling covered with a nonflaking finish that allows easy cleaning; and (i) be well lit, ventilated and have appropriate air-control facilities including temperature, humidity, and filtration for the operations to be undertaken.

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.

10. Premises to be in good state of repair and decoration

(1)

The premises shall be maintained in a good state of repair and decoration. (2) The process of maintenance and repair shall not while being carried out cause any contamination of ingredients or products.

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

Mandatory duty

This section imposes mandatory requirements concerning “Premises to be in good state of repair and decoration”.

“(1) The premises shall be maintained in a good state of repair and decoration. (2) The process of maintenance and repair shall not while being carried out cause any contamination of ingredients or products.”

Primary legislation Source quotation matched

Practical effect

The provision uses mandatory language; the responsible person or institution should be able to demonstrate compliance.

Deterministic editorial synthesis — not a substitute for the statutory text Editorial synthesis approved

Elements or requirements

Operative requirements extracted from the consolidated text.

1

(1) The premises shall be maintained in a good state of repair and decoration. (2) The process of maintenance and repair shall not while being carried out cause any contamination of ingredients or products.

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.

11. Manufacturing and processing areas to be separate

Any animal house, cloakroom and any other staff area shall be separated from the processing and manufacturing areas and food shall not be brought into the processing or manufacturing areas.

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

Mandatory duty

This section imposes mandatory requirements concerning “Manufacturing and processing areas to be separate”.

“Any animal house, cloakroom and any other staff area shall be separated from the processing and manufacturing areas and food shall not be brought into the processing or manufacturing areas.”

Primary legislation Source quotation matched

Practical effect

The provision uses mandatory language; the responsible person or institution should be able to demonstrate compliance.

Deterministic editorial synthesis — not a substitute for the statutory text Editorial synthesis approved

Elements or requirements

Operative requirements extracted from the consolidated text.

1

Any animal house, cloakroom and any other staff area shall be separated from the processing and manufacturing areas and food shall not be brought into the processing or manufacturing areas.

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.

12. Premises to be clean and tidy

The premises including the external surroundings shall be maintained in a clean and tidy condition with regular and adequate clearance of waste materials.

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

Mandatory duty

This section imposes mandatory requirements concerning “Premises to be clean and tidy”.

“The premises including the external surroundings shall be maintained in a clean and tidy condition with regular and adequate clearance of waste materials.”

Primary legislation Source quotation matched

Practical effect

The provision uses mandatory language; the responsible person or institution should be able to demonstrate compliance.

Deterministic editorial synthesis — not a substitute for the statutory text Editorial synthesis approved

Elements or requirements

Operative requirements extracted from the consolidated text.

1

The premises including the external surroundings shall be maintained in a clean and tidy condition with regular and adequate clearance of waste materials.

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.

13. Regular water supply

The premises shall have a regular and sufficient supply of water.

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

Mandatory duty

This section imposes mandatory requirements concerning “Regular water supply”.

“The premises shall have a regular and sufficient supply of water.”

Primary legislation Source quotation matched

Practical effect

The provision uses mandatory language; the responsible person or institution should be able to demonstrate compliance.

Deterministic editorial synthesis — not a substitute for the statutory text Editorial synthesis approved

Elements or requirements

Operative requirements extracted from the consolidated text.

1

The premises shall have a regular and sufficient supply of water.

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.

14. Storage areas

The materials and goods shall be stored under cover and off the floor in an area- (a) that has sufficient space; (b) that is laid out to allow clear separation of different materials

and products to minimise the risk of mixing them up; (c) that is secure; and

(d)

where access to the materials and goods is restricted to authorised personnel only.

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

Mandatory duty

This section imposes mandatory requirements concerning “Storage areas”.

“The materials and goods shall be stored under cover and off the floor in an area- (a) that has sufficient space; (b) that is laid out to allow clear separation of different materials”

Primary legislation Source quotation matched

Practical effect

The provision uses mandatory language; the responsible person or institution should be able to demonstrate compliance.

Deterministic editorial synthesis — not a substitute for the statutory text Editorial synthesis approved

Elements or requirements

Operative requirements extracted from the consolidated text.

1

(d) where access to the materials and goods is restricted to authorised personnel only.

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.

15. Materials to be protected against light

(1)

The materials to be used in the manufacturing of drugs and the finished products shall be protected from light, heat and moisture.

(2)

The ingredients and finished drugs that are temperaturesensitive shall be kept in a temperature controlled storage facility.

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

Mandatory duty

This section imposes mandatory requirements concerning “Materials to be protected against light”.

“(1) The materials to be used in the manufacturing of drugs and the finished products shall be protected from light, heat and moisture.”

Primary legislation Source quotation matched

Practical effect

The provision uses mandatory language; the responsible person or institution should be able to demonstrate compliance.

Deterministic editorial synthesis — not a substitute for the statutory text Editorial synthesis approved

Elements or requirements

Operative requirements extracted from the consolidated text.

2

(1) The materials to be used in the manufacturing of drugs and the finished products shall be protected from light, heat and moisture.
(2) The ingredients and finished drugs that are temperaturesensitive shall be kept in a temperature controlled storage facility.

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.

16. Unprocessed ingredients to be stored separately

(1)

The ingredients which are not processed shall be stored separately from finished products.

(2)

The recalled, expired or rejected drugs shall be stored in a separate area in the storage facility.

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

Mandatory duty

This section imposes mandatory requirements concerning “Unprocessed ingredients to be stored separately”.

“(1) The ingredients which are not processed shall be stored separately from finished products.”

Primary legislation Source quotation matched

Practical effect

The provision uses mandatory language; the responsible person or institution should be able to demonstrate compliance.

Deterministic editorial synthesis — not a substitute for the statutory text Editorial synthesis approved

Elements or requirements

Operative requirements extracted from the consolidated text.

2

(1) The ingredients which are not processed shall be stored separately from finished products.
(2) The recalled, expired or rejected drugs shall be stored in a separate area in the storage facility.

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.

17. Quarantine areas for goods awaiting release

There shall be established designated separate or quarantine areas, for the materials and products due for release.

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

Mandatory duty

This section imposes mandatory requirements concerning “Quarantine areas for goods awaiting release”.

“There shall be established designated separate or quarantine areas, for the materials and products due for release.”

Primary legislation Source quotation matched

Practical effect

The provision uses mandatory language; the responsible person or institution should be able to demonstrate compliance.

Deterministic editorial synthesis — not a substitute for the statutory text Editorial synthesis approved

Elements or requirements

Operative requirements extracted from the consolidated text.

1

There shall be established designated separate or quarantine areas, for the materials and products due for release.

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.

18. Containers to be cleaned

All containers shall be cleaned before they are stored and shall be rechecked for cleanliness before being issued out to the manufacturing areas.

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

Mandatory duty

This section imposes mandatory requirements concerning “Containers to be cleaned”.

“All containers shall be cleaned before they are stored and shall be rechecked for cleanliness before being issued out to the manufacturing areas.”

Primary legislation Source quotation matched

Practical effect

The provision uses mandatory language; the responsible person or institution should be able to demonstrate compliance.

Deterministic editorial synthesis — not a substitute for the statutory text Editorial synthesis approved

Elements or requirements

Operative requirements extracted from the consolidated text.

1

All containers shall be cleaned before they are stored and shall be rechecked for cleanliness before being issued out to the manufacturing areas.

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.

19. Descriptive materials to be kept secure

(1)

All labels, printed packaging and descriptive materials shall- (a) be stored in a secure manner; and

(b)

be accessed by only authorised personnel.

(2)

Proper records shall be kept of the labels, printed packaging and descriptive materials issued, to avoid any mix-up.

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

Mandatory duty

This section imposes mandatory requirements concerning “Descriptive materials to be kept secure”.

“(1) All labels, printed packaging and descriptive materials shall- (a) be stored in a secure manner; and”

Primary legislation Source quotation matched

Practical effect

The provision uses mandatory language; the responsible person or institution should be able to demonstrate compliance.

Deterministic editorial synthesis — not a substitute for the statutory text Editorial synthesis approved

Elements or requirements

Operative requirements extracted from the consolidated text.

3

(1) All labels, printed packaging and descriptive materials shall- (a) be stored in a secure manner; and
(b) be accessed by only authorised personnel.
(2) Proper records shall be kept of the labels, printed packaging and descriptive materials issued, to avoid any mix-up.

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.

20. Design, location and maintenance of equipment

The equipment shall be- (a) designed and located to fit the purpose for which it is to be used; and

(b)

maintained in good mechanical, electrical and clean condition as per a regular servicing schedule and written cleaning procedures.

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

Mandatory duty

This section imposes mandatory requirements concerning “Design, location and maintenance of equipment”.

“The equipment shall be- (a) designed and located to fit the purpose for which it is to be used; and”

Primary legislation Source quotation matched

Practical effect

The provision uses mandatory language; the responsible person or institution should be able to demonstrate compliance.

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) maintained in good mechanical, electrical and clean condition as per a regular servicing schedule and written cleaning procedures.

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.

21. Particular maintenance requirements

The equipment shall be free of leaking joints, lubricants, electrical faults or other faults that may prove a hazard to staff or the products.

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 “Particular maintenance requirements”.

“The equipment shall be free of leaking joints, lubricants, electrical faults or other faults that may prove a hazard to staff or the products.”

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.

1

The equipment shall be free of leaking joints, lubricants, electrical faults or other faults that may prove a hazard to staff or the products.

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.

22. Fire-fighting equipment

The premises shall have sufficient fire-fighting equipment which shall, at all times be in good condition and accessible.

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

Mandatory duty

This section imposes mandatory requirements concerning “Fire-fighting equipment”.

“The premises shall have sufficient fire-fighting equipment which shall, at all times be in good condition and accessible.”

Primary legislation Source quotation matched

Practical effect

The provision uses mandatory language; the responsible person or institution should be able to demonstrate compliance.

Deterministic editorial synthesis — not a substitute for the statutory text Editorial synthesis approved

Elements or requirements

Operative requirements extracted from the consolidated text.

1

The premises shall have sufficient fire-fighting equipment which shall, at all times be in good condition and accessible.

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.

23. First-aid box

The premises shall have a first-aid box complying with the specifications contained in the Occupational Health and Safety Act, 2006.

24. Weighing, measuring, testing and recording equipment to be checked. The equipment used for weighing, measuring, testing and recording shall be subjected to recorded checks for accuracy in accordance with a regular set schedule.

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

Mandatory duty

This section imposes mandatory requirements concerning “First-aid box”.

“The premises shall have a first-aid box complying with the specifications contained in the Occupational Health and Safety Act, 2006.”

Primary legislation Source quotation matched

Practical effect

The provision uses mandatory language; the responsible person or institution should be able to demonstrate compliance.

Deterministic editorial synthesis — not a substitute for the statutory text Editorial synthesis approved

Elements or requirements

Operative requirements extracted from the consolidated text.

2

The premises shall have a first-aid box complying with the specifications contained in the Occupational Health and Safety Act, 2006.
24. Weighing, measuring, testing and recording equipment to be checked. The equipment used for weighing, measuring, testing and recording shall be subjected to recorded checks for accuracy in accordance with a regular set schedule.

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.

25. Compliance with Good Manufacturing Practice Guidelines

The premises shall comply with the internationally accepted Good Manufacturing Practice Guidelines approved by the Authority

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 “Compliance with Good Manufacturing Practice Guidelines”.

“The premises shall comply with the internationally accepted Good Manufacturing Practice Guidelines approved by the Authority”

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.

1

The premises shall comply with the internationally accepted Good Manufacturing Practice Guidelines approved by the Authority

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.

26. Regulations applicable to Part III

Regulations 8, 9 (a), (b), (c), (h) and (i) and 10, 12, 15 and 16 in Part II of these Regulations apply to this Part.

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

Governing rule

This section states the governing statutory rule for “Regulations applicable to Part III”.

“Regulations 8, 9 (a), (b), (c), (h) and (i) and 10, 12, 15 and 16 in Part II of these Regulations apply to this Part.”

Primary legislation Source quotation matched

Practical effect

Use this section as the starting statutory rule for “Regulations applicable to Part III”, 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.

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.

27. Toilet facilities

(1)

The premises shall have adequate toilet facilities, one of which shall not be shared with any other premises.

(2)

The toilet facilities shall-

(a)

be well ventilated;

(b)

not be directly open to any storage area;

(c)

be fitted with a sink; and

(d)

have running water.

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

Mandatory duty

This section imposes mandatory requirements concerning “Toilet facilities”.

“(1) The premises shall have adequate toilet facilities, one of which shall not be shared with any other premises.”

Primary legislation Source quotation matched

Practical effect

The provision uses mandatory language; the responsible person or institution should be able to demonstrate compliance.

Deterministic editorial synthesis — not a substitute for the statutory text Editorial synthesis approved

Elements or requirements

Operative requirements extracted from the consolidated text.

6

(1) The premises shall have adequate toilet facilities, one of which shall not be shared with any other premises.
(2) The toilet facilities shall-
(a) be well ventilated;
(b) not be directly open to any storage area;
(c) be fitted with a sink; and
(d) have running water.

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.

28. Class A and class B drugs to be separated from class C drugs

(1)

Class A and class B drugs shall be kept separate from the class C drugs.

(2)

The narcotic and psychotropic drugs shall be kept in a secure, fixed and lockable storage place.

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

Mandatory duty

This section imposes mandatory requirements concerning “Class A and class B drugs to be separated from class C drugs”.

“(1) Class A and class B drugs shall be kept separate from the class C drugs.”

Primary legislation Source quotation matched

Practical effect

The provision uses mandatory language; the responsible person or institution should be able to demonstrate compliance.

Deterministic editorial synthesis — not a substitute for the statutory text Editorial synthesis approved

Elements or requirements

Operative requirements extracted from the consolidated text.

2

(1) Class A and class B drugs shall be kept separate from the class C drugs.
(2) The narcotic and psychotropic drugs shall be kept in a secure, fixed and lockable storage place.

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.

29. Premises to be of sufficient space

(1)

The premises shall have sufficient space to avoid overcrowding of customers and staff.

(2)

The minimum floor area for storage of drugs shall be at least 25 square metres and the sales and administrative area shall occupy a continuous space of at least 16 square metres.

(3)

The premises shall be well lit, ventilated and secure.

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

Mandatory duty

This section imposes mandatory requirements concerning “Premises to be of sufficient space”.

“(1) The premises shall have sufficient space to avoid overcrowding of customers and staff.”

Primary legislation Source quotation matched

Practical effect

The provision uses mandatory language; the responsible person or institution should be able to demonstrate compliance.

Deterministic editorial synthesis — not a substitute for the statutory text Editorial synthesis approved

Elements or requirements

Operative requirements extracted from the consolidated text.

3

(1) The premises shall have sufficient space to avoid overcrowding of customers and staff.
(2) The minimum floor area for storage of drugs shall be at least 25 square metres and the sales and administrative area shall occupy a continuous space of at least 16 square metres.
(3) The premises shall be well lit, ventilated and secure.

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.

30. Administrative area

There shall be a separate office or administrative area, with a full view of the sales area, for the pharmacist and the prescriptions, purchase

records and other administrative records shall be maintained in this office or area.

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

Mandatory duty

This section imposes mandatory requirements concerning “Administrative area”.

“There shall be a separate office or administrative area, with a full view of the sales area, for the pharmacist and the prescriptions, purchase”

Primary legislation Source quotation matched

Practical effect

The provision uses mandatory language; the responsible person or institution should be able to demonstrate compliance.

Deterministic editorial synthesis — not a substitute for the statutory text Editorial synthesis approved

Elements or requirements

Operative requirements extracted from the consolidated text.

2

There shall be a separate office or administrative area, with a full view of the sales area, for the pharmacist and the prescriptions, purchase
records and other administrative records shall be maintained in this office or area.

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.

31. Regulations applicable to this Part

Regulations 8, 9 (a), (b), (c), (h) and (i), and 10, 15, and 16 in Part II of these Regulations apply to this Part.

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

Governing rule

This section states the governing statutory rule for “Regulations applicable to this Part”.

“Regulations 8, 9 (a), (b), (c), (h) and (i), and 10, 15, and 16 in Part II of these Regulations apply to this Part.”

Primary legislation Source quotation matched

Practical effect

Use this section as the starting statutory rule for “Regulations applicable to this Part”, 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.

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.

32. Premises to be of sufficient space

(1)

The premises shall have sufficient space to avoid overcrowding of customers and staff. (2) The minimum floor area for sales and administrative shall be at least 16 square metres and the dispensing area shall occupy a continuous space of at least 4 square metres.

(3)

The premises shall be well lit, ventilated and secure.

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

Mandatory duty

This section imposes mandatory requirements concerning “Premises to be of sufficient space”.

“(1) The premises shall have sufficient space to avoid overcrowding of customers and staff. (2) The minimum floor area for sales and administrative shall be at least 16 square metres and the dispensing area shall occupy a continuous space of at least 4 square metres.”

Primary legislation Source quotation matched

Practical effect

The provision uses mandatory language; the responsible person or institution should be able to demonstrate compliance.

Deterministic editorial synthesis — not a substitute for the statutory text Editorial synthesis approved

Elements or requirements

Operative requirements extracted from the consolidated text.

2

(1) The premises shall have sufficient space to avoid overcrowding of customers and staff. (2) The minimum floor area for sales and administrative shall be at least 16 square metres and the dispensing area shall occupy a continuous space of at least 4 square metres.
(3) The premises shall be well lit, ventilated and secure.

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.

33. Drugs in dispensing area to be protected against light

(1)

The drugs in the dispensing and storage areas shall be adequately protected from light, heat and moisture.

(2)

The narcotic and psychotropic drugs shall be kept separate from all other drugs and shall be kept in secure, fixed and lockable places.

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

Mandatory duty

This section imposes mandatory requirements concerning “Drugs in dispensing area to be protected against light”.

“(1) The drugs in the dispensing and storage areas shall be adequately protected from light, heat and moisture.”

Primary legislation Source quotation matched

Practical effect

The provision uses mandatory language; the responsible person or institution should be able to demonstrate compliance.

Deterministic editorial synthesis — not a substitute for the statutory text Editorial synthesis approved

Elements or requirements

Operative requirements extracted from the consolidated text.

2

(1) The drugs in the dispensing and storage areas shall be adequately protected from light, heat and moisture.
(2) The narcotic and psychotropic drugs shall be kept separate from all other drugs and shall be kept in secure, fixed and lockable places.

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.

34. Dispensing area not accessible to public

(1)

The dispensing area shall be a separate lockable area without access for the public and it shall have benches and working surfaces with impervious washable tops and shall be fitted with a sink with running water.

(2)

The class A and class B drugs shall be within the dispensing area and shall be kept out of the reach of the public.

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

Mandatory duty

This section imposes mandatory requirements concerning “Dispensing area not accessible to public”.

“(1) The dispensing area shall be a separate lockable area without access for the public and it shall have benches and working surfaces with impervious washable tops and shall be fitted with a sink with running water.”

Primary legislation Source quotation matched

Practical effect

The provision uses mandatory language; the responsible person or institution should be able to demonstrate compliance.

Deterministic editorial synthesis — not a substitute for the statutory text Editorial synthesis approved

Elements or requirements

Operative requirements extracted from the consolidated text.

2

(1) The dispensing area shall be a separate lockable area without access for the public and it shall have benches and working surfaces with impervious washable tops and shall be fitted with a sink with running water.
(2) The class A and class B drugs shall be within the dispensing area and shall be kept out of the reach of the public.

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.

35. Regulations applicable to premises for sale of class C drugs

Regulations 8, 9 (h), 10, 13 and 29 of these Regulations apply to this Part.

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

Governing rule

This section states the governing statutory rule for “Regulations applicable to premises for sale of class C drugs”.

“Regulations 8, 9 (h), 10, 13 and 29 of these Regulations apply to this Part.”

Primary legislation Source quotation matched

Practical effect

Use this section as the starting statutory rule for “Regulations applicable to premises for sale of class C drugs”, 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.

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.

36. Premises to have direct access

The premises shall be of a permanent nature with direct access to the public.

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

Mandatory duty

This section imposes mandatory requirements concerning “Premises to have direct access”.

“The premises shall be of a permanent nature with direct access to the public.”

Primary legislation Source quotation matched

Practical effect

The provision uses mandatory language; the responsible person or institution should be able to demonstrate compliance.

Deterministic editorial synthesis — not a substitute for the statutory text Editorial synthesis approved

Elements or requirements

Operative requirements extracted from the consolidated text.

1

The premises shall be of a permanent nature with direct access to the public.

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.

37. Premises shall not be shared with similar business

The premises shall not be shared with any medical clinic, veterinary surgery or any other business.

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

Mandatory duty

This section imposes mandatory requirements concerning “Premises shall not be shared with similar business”.

“The premises shall not be shared with any medical clinic, veterinary surgery or any other business.”

Primary legislation Source quotation matched

Practical effect

The provision uses mandatory language; the responsible person or institution should be able to demonstrate compliance.

Deterministic editorial synthesis — not a substitute for the statutory text Editorial synthesis approved

Elements or requirements

Operative requirements extracted from the consolidated text.

1

The premises shall not be shared with any medical clinic, veterinary surgery or any other business.

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.

38. Drugs to be protected against light, heat and moisture

Class C drugs shall be adequately protected against light, heat and moisture.

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

Mandatory duty

This section imposes mandatory requirements concerning “Drugs to be protected against light, heat and moisture”.

“Class C drugs shall be adequately protected against light, heat and moisture.”

Primary legislation Source quotation matched

Practical effect

The provision uses mandatory language; the responsible person or institution should be able to demonstrate compliance.

Deterministic editorial synthesis — not a substitute for the statutory text Editorial synthesis approved

Elements or requirements

Operative requirements extracted from the consolidated text.

1

Class C drugs shall be adequately protected against light, heat and moisture.

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.

39. Premises to be of sufficient space

(1)

The premises shall have sufficient space to avoid overcrowding of customers and staff.

(2)

The minimum floor area of the premises shall be at least 4 square metres.

(3)

The premises shall be well lit, ventilated and secure.

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

Mandatory duty

This section imposes mandatory requirements concerning “Premises to be of sufficient space”.

“(1) The premises shall have sufficient space to avoid overcrowding of customers and staff.”

Primary legislation Source quotation matched

Practical effect

The provision uses mandatory language; the responsible person or institution should be able to demonstrate compliance.

Deterministic editorial synthesis — not a substitute for the statutory text Editorial synthesis approved

Elements or requirements

Operative requirements extracted from the consolidated text.

3

(1) The premises shall have sufficient space to avoid overcrowding of customers and staff.
(2) The minimum floor area of the premises shall be at least 4 square metres.
(3) The premises shall be well lit, ventilated and secure.

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.

40. Revocation of S.I 206 -

The National Drug Policy and Authority (Certificate of Suitability of Premises) Regulations, S.I 206-4 are revoked.

SCHEDULE. FORMS.

Application for a Certificate of Suitability of Premises for Premises for Manufacturing Drugs.

National Drug Policy and Authority Act, Cap 206.

Full names of applicant ____________________________________________ P. O. Box No. __________ Tel. ______________ Fax _______________email Physical address of premises for which certificate is applied for ____________ County______________________________ Sub county___________________________

If applying as representative of the applicant indicate: Name of representative ____________________________________________ Physical address of registered office __________________________________ P.O. Box No. __________ Tel. __________ Fax ___________Email_________ Plot No___ Street Name____________

The form of the drug to be manufactured on the premises (tick as approppriate)- Tablets _____ Capsules _____ Antibiotics _____ Injections (vials) _____ Injections (ampoules) _____ Injections (I.V. fluids) _____ Other sterile products ______________________________ syrup/mixtures _______________________________________ creams/ointments/loti

Others (specify) ________________________________________________

I certify that the above information is correct.

_______________________________ __________________________ Signature of applicant Date

Application for a Certificate of Suitability of Premises for a Wholesale Pharmacy.

National Drug Policy and Authority Act, Cap 206.

Full names of applicant ____________________________________________ P. O. Box No. __________ Tel. ______________ Fax _______________email Physical address of premises for which certificate is applied for ____________ County______________________________ Sub county___________________________

If applying as representative of the applicant indicate: Name of representative _________________________ Physical address of registered office ________________________________ P.O. Box No. __________ Tel. __________ Fax __________Email_________ Plot No_______ Street Name______________

Name and approximate distance of nearest wholesale pharmacy to the premises for which certificate is applied for ___________________________________

I certify that the above information is correct.

____________________________ _____________________ Signature of applicant Date

Application for Certificate of Suitability of Premises for a Retail Pharmacy.

National Drug Policy and Authority Act, |Cap 206.

Full names of applicant _________________________________________ P. O. Box No. _________ Tel. ______________ Fax _______________email Physical address of premises for which certificate is applied for __________ County______________________________ Sub county___________________________

If applying as representative of the applicant indicate: Name of representative _________________________ Physical address of registered office ________________________________ P.O. Box No. __________ Tel. ________ Fax _____________Email________ Plot No___ Street Name______________

Name and approximate distance of nearest retail pharmacy to the premises applied for __________________________________________________ Purposes for which premises are to be licensed (tick proposed activities)-

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 “Revocation of S.I 206 -”.

“The National Drug Policy and Authority (Certificate of Suitability of Premises) Regulations, S.I 206-4 are revoked.”

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.

3

If applying as representative of the applicant indicate: Name of representative ____________________________________________ Physical address of registered office __________________________________ P.O. Box No. __________ Tel. __________ Fax ___________Email_________ Plot No___ Street Name____________
If applying as representative of the applicant indicate: Name of representative _________________________ Physical address of registered office ________________________________ P.O. Box No. __________ Tel. __________ Fax __________Email_________ Plot No_______ Street Name______________
If applying as representative of the applicant indicate: Name of representative _________________________ Physical address of registered office ________________________________ P.O. Box No. __________ Tel. ________ Fax _____________Email________ Plot No___ Street Name______________

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

National Drug Policy and Authority Act

Amendment notes

No section-specific amendment note or instrument-level amendment history appears in this consolidation.

1. Retail pharmacy _________________________________

The text of this section isn't in the consolidation we hold — see the original PDF above.

2. Dispensing prescriptions ___________________________

The text of this section isn't in the consolidation we hold — see the original PDF above.

3. Compounding for prescription ______________________

The text of this section isn't in the consolidation we hold — see the original PDF above.

4. Compounding for retail sale ________________________

The text of this section isn't in the consolidation we hold — see the original PDF above.

5. Packing ________________________________________

I certify that the above information is correct.

________________________________ ____________________ Signature of applicant Date

Application For a Certificate of Suitability of Premises for Operating as a Licensed Seller.

National Drug Policy and Authority Act, Cap 206.

Full names of applicant _________________________________________ P. O. Box No. __________ Tel. ______________ Fax _______________email Physical address of premises for which certificate is applied for ____________ County______________________________ Sub county___________________________

Name and approximate distance of the premises of the nearest licensed seller to the premises for which application is made __________________________

Are the premises to be used for the sale of human drugs/veterinary drugs/both (delete as applicable)?

I certify that the above information is correct.

____________________________ __________________________ Signature of applicant Date

Inspection Report- Wholesale Pharmacy.

National Drug Policy and Authority Act, Cap 206.

Part A-Premises. Name of the pharmacy ____________________________________________ Physical address _________________________________________________ Postal address ________________________________________________ Telephone ______________________ Fax ____________________________ Email__________________________________________________________ Street name____________________________________________________ Plot no: ________________________________________________________

Construction and finish of the premises: Good Needs attention Poor condition Walls: Shop area ........... .......... ...............

Roof/ceiling: Shop area

Floor: Shop area

Lighting: Shop area

Ventilation: Shop area

Toilet(s):

General external environment ____________________________________ Part B- Storage area.

Overall size of store ____________________ x ___________________ metres Is the floor dry and sound? Yes/No Is the roof/ceiling waterproof? Yes/No Is there adequate cool/cold storage space for temperature-sensitive stocks? Yes/No Are chemicals and ingredients kept separate from finished products? Yes/No Are expired/returned/rejected drugs kept separate from salable stock? Yes/No Is the shelving/racking/palleting in good condition? Yes/No Is there sufficient security, burglar bars, etc? Yes/No

About this Act

Full text of the Act

Part I

1. Title

2. Interpretation

3. Approval of location by the Authority

4. Certificate of suitability of premises

5. Application for certificate of suitability of premises

6. Inspection of premises

7. Suitability of premises

Part II

8. Location of premises

9. Standards of construction

10. Premises to be in good state of repair and decoration

11. Manufacturing and processing areas to be separate

12. Premises to be clean and tidy

13. Regular water supply

14. Storage areas

15. Materials to be protected against light

16. Unprocessed ingredients to be stored separately

17. Quarantine areas for goods awaiting release

18. Containers to be cleaned

19. Descriptive materials to be kept secure

20. Design, location and maintenance of equipment

21. Particular maintenance requirements

22. Fire-fighting equipment

23. First-aid box

25. Compliance with Good Manufacturing Practice Guidelines

Part III

26. Regulations applicable to Part III

27. Toilet facilities

28. Class A and class B drugs to be separated from class C drugs

29. Premises to be of sufficient space

30. Administrative area

Part IV

31. Regulations applicable to this Part

32. Premises to be of sufficient space

33. Drugs in dispensing area to be protected against light

34. Dispensing area not accessible to public

Part V

35. Regulations applicable to premises for sale of class C drugs

36. Premises to have direct access

37. Premises shall not be shared with similar business

38. Drugs to be protected against light, heat and moisture

39. Premises to be of sufficient space

Part VI

40. Revocation of S.I 206 -

1. Retail pharmacy _________________________________

2. Dispensing prescriptions ___________________________

3. Compounding for prescription ______________________

4. Compounding for retail sale ________________________

5. Packing ________________________________________

Part C

Part D

Part C