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National Drug Policy and Authority (Licensing) Regulations

Statutory Instrument 35 of 2014 Current version · as at 28 March 2014
Enacted2014
Commenced28 March 2014
Last amended—
Point-in-time consolidation · as at 28 March 2014. This page may not reflect amendments made after that date. Confirm the current position against the latest Uganda Gazette before relying on it.

About this Act

A full descriptive summary for this Act has not been recorded yet.

Jurisdiction
Uganda
Type
Principal Legislation
Status
In force
Language
English

Full text of the Act

7 parts · 41 sections

Enhanced Annotated View adds approved, source-linked propositions, operative requirements, judicial passages, related provisions, amendment notes and authority status. Choose Original PDF to inspect the source consolidation.

Uganda

National Drug Policy and Authority (Licensing) Regulations

Commenced on 28 March 2014

[This is the version of this document at 28 March 2014.]

Part I

1. Title

These Regulations may be cited as the National Drug Policy and Authority (Licensing) 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 (Licensing) 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
  1. These Regulations may be cited as the National Drug Policy and Authority (Licensing) 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.

Authority status: legislation is primary authority; judgment weight follows the displayed court level and the ratio caveat. Check version history
2. Interpretation

In these Regulations, unless the context otherwise requires-

"Act" means the National Drug Policy and Authority Act, Cap. 206;

"Authority" means National Drug Authority;

"licenced 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-”
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.

4
  1. "Act" means the National Drug Policy and Authority Act, Cap. 206;
  2. "Authority" means National Drug Authority;
  3. "licenced person" means a person licensed under section 14 of the Act;
  4. "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 · Reference books Section 15 · Application for licence to operate wholesale pharmacy National Drug Policy and Authority Act
Amendment notes

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

Authority status: legislation is primary authority; judgment weight follows the displayed court level and the ratio caveat. Check version history
3. Obligation to obtain a licence

A person shall not without a licence issued by the Authority in accordance with the Act and these Regulations-

(a)

operate as a licensed seller or import or export drugs; or (b) carry on the business of manufacturing or supplying by wholesale or retail of drugs.

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 “Obligation to obtain a licence”.

“A person shall not without a licence issued by the Authority in accordance with the Act and these 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.

1
  1. (a) operate as a licensed seller or import or export drugs; or (b) carry on the business of manufacturing or supplying by wholesale or retail of drugs.
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.

Authority status: legislation is primary authority; judgment weight follows the displayed court level and the ratio caveat. Check version history

Part II

4. Application for a licence to sell Class C drugs
(1)

A person shall not sell Class C drugs without a licence issued by the Authority. (2) An application for a licence to sell Class C drugs shall be made using Form 16 in the Schedule to these Regulations. (3) The application referred to in sub regulation (2) shall be accompanied by a certified copy of the certificate of registration issued to the applicant or an employee of the applicant by the relevant allied health professional council, authorising the person to practice as a professional.

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 a licence to sell Class C drugs” applies.

“(1) A person shall not sell Class C drugs without a licence issued by the Authority. (2) An application for a licence to sell Class C drugs shall be made using Form 16 in the Schedule to these Regulations. (3) The application referred to in sub regulation (2) shall be accompanied by a certified copy of the certificate of registration issued to the applicant or an employee of the applicant by the relevant allied health professional council, authorising the person to practice as a professional.”
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. (1) A person shall not sell Class C drugs without a licence issued by the Authority. (2) An application for a licence to sell Class C drugs shall be made using Form 16 in the Schedule to these Regulations. (3) The application referred to in sub regulation (2) shall be accompanied by a certified copy of the certificate of registration issued to the applicant or an employee of the applicant by the relevant allied health professional council, authorising the person to practice as a professional.
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.

Authority status: legislation is primary authority; judgment weight follows the displayed court level and the ratio caveat. Check version history
5. Licence to operate as a licensed seller

The Authority shall issue to an applicant a licence to sell Class C drugs where the applicant- (a) holds a certificate of suitability of premises issued by the Authority; (b) has not been previously convicted of an offence involving wrongful or illegal dealing in supply or possession of drugs; (c) complies with the internationally accepted Good Distribution Practice Guidelines adopted by the Authority; and (d) pays the prescribed fees.

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
Offence or consequence

This section creates or governs statutory liability concerning “Licence to operate as a licensed seller”.

“The Authority shall issue to an applicant a licence to sell Class C drugs where the applicant- (a) holds a certificate of suitability of premises issued by the Authority; (b) has not been previously convicted of an offence involving wrongful or illegal dealing in supply or possession of drugs; (c) complies with the internationally accepted Good Distribution Practice Guidelines adopted by the Authority; and (d) pays the prescribed fees.”
Primary legislation Source quotation matched
Practical effect

A party alleging or defending liability should test the facts and prescribed consequence against each operative requirement.

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 issue to an applicant a licence to sell Class C drugs where the applicant- (a) holds a certificate of suitability of premises issued by the Authority; (b) has not been previously convicted of an offence involving wrongful or illegal dealing in supply or possession of drugs; (c) complies with the internationally accepted Good Distribution Practice Guidelines adopted by the Authority; and (d) pays the prescribed fees.
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.

Authority status: legislation is primary authority; judgment weight follows the displayed court level and the ratio caveat. Check version history
6. Licensed seller to sell only class C drugs
(1)

A person who is issued a licence by the Authority to operate as a licensed seller shall sell only Class C drugs specified in the Third Schedule to the Act and shall not sell any Class A or B drugs, specified in the First and Second Schedules to the Act.

(2)

A licensed seller who contravenes subregulation (1) commits an offence.

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
Offence or consequence

This section creates or governs statutory liability concerning “Licensed seller to sell only class C drugs”.

“(1) A person who is issued a licence by the Authority to operate as a licensed seller shall sell only Class C drugs specified in the Third Schedule to the Act and shall not sell any Class A or B drugs, specified in the First and Second Schedules to the Act.”
Primary legislation Source quotation matched
Practical effect

A party alleging or defending liability should test the facts and prescribed consequence against each operative requirement.

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. (1) A person who is issued a licence by the Authority to operate as a licensed seller shall sell only Class C drugs specified in the Third Schedule to the Act and shall not sell any Class A or B drugs, specified in the First and Second Schedules to the Act.
  2. (2) A licensed seller who contravenes subregulation (1) commits an offence.
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.

Authority status: legislation is primary authority; judgment weight follows the displayed court level and the ratio caveat. Check version history
7. Requirements for operating as a licensed seller
(1)

A licensed seller or an employee of a licensed seller shall hold a qualification in a relevant pharmaceutical, medical, veterinary, nursing or other paramedical field, approved by the National Drug Authority.

(2)

A licensed seller shall- (a) keep the drugs in suitable containers, which shall be appropriately labelled; (b) keep records of all drugs procured by the licensed seller; and

(c)

comply with any other requirements as may be specified 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 “Requirements for operating as a licensed seller”.

“(1) A licensed seller or an employee of a licensed seller shall hold a qualification in a relevant pharmaceutical, medical, veterinary, nursing or other paramedical field, approved by the National Drug 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.

3
  1. (1) A licensed seller or an employee of a licensed seller shall hold a qualification in a relevant pharmaceutical, medical, veterinary, nursing or other paramedical field, approved by the National Drug Authority.
  2. (2) A licensed seller shall- (a) keep the drugs in suitable containers, which shall be appropriately labelled; (b) keep records of all drugs procured by the licensed seller; and
  3. (c) comply with any other requirements as may be specified 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.

Authority status: legislation is primary authority; judgment weight follows the displayed court level and the ratio caveat. Check version history
8. Records to be kept by licensed seller
(1)

The records referred to in regulation 7(2) (b) include-

(a)

the source of supply of the drugs;

(b)

the date of purchase of the drugs;

(c)

the name and quantity of the drug;

(d)

the Dispensing Register containing the details of the patient and drug information; and

(e)

the batch number and date of expiry of the drugs.

(2)

The records shall be retained for a minimum of five years and shall be available for inspection by an inspector of drugs at all reasonable times.

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 “Records to be kept by licensed seller”.

“(1) The records referred to in regulation 7(2) (b) include-”
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.

7
  1. (1) The records referred to in regulation 7(2) (b) include-
  2. (a) the source of supply of the drugs;
  3. (b) the date of purchase of the drugs;
  4. (c) the name and quantity of the drug;
  5. (d) the Dispensing Register containing the details of the patient and drug information; and
  6. (e) the batch number and date of expiry of the drugs.
  7. (2) The records shall be retained for a minimum of five years and shall be available for inspection by an inspector of drugs at all reasonable times.
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.

Authority status: legislation is primary authority; judgment weight follows the displayed court level and the ratio caveat. Check version history
9. Location of premises of licensed sellers
(1)

The premises of a licensed seller shall be located at a distance of at least one and a half kilometres from a retail pharmacy.

(2)

Where the premises of a licensed seller who is licensed before the commencement of these Regulations do not conform to the requirements of subregulation (1), the licensed seller shall within one year from the date of commencement of these Regulations- (a) apply for a licence to operate as a licensed person, where the licensed seller is qualified to operate as a licensed person; (b) relocate the business to another underserved area; or (c) operate the business of licensed seller for one year from the commencement of these Regulations and then cease operation. (3) A licensed seller who wishes to relocate the business to another premises under subregulation (2) (b), shall obtain the authorisation of the Authority prior to the relocation.

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 “Location of premises of licensed sellers”.

“(1) The premises of a licensed seller shall be located at a distance of at least one and a half kilometres from a retail pharmacy.”
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.

2
  1. (1) The premises of a licensed seller shall be located at a distance of at least one and a half kilometres from a retail pharmacy.
  2. (2) Where the premises of a licensed seller who is licensed before the commencement of these Regulations do not conform to the requirements of subregulation (1), the licensed seller shall within one year from the date of commencement of these Regulations- (a) apply for a licence to operate as a licensed person, where the licensed seller is qualified to operate as a licensed person; (b) relocate the business to another underserved area; or (c) operate the business of licensed seller for one year from the commencement of these Regulations and then cease operation. (3) A licensed seller who wishes to relocate the business to another premises under subregulation (2) (b), shall obtain the authorisation of the Authority prior to the relocation.
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.

Authority status: legislation is primary authority; judgment weight follows the displayed court level and the ratio caveat. Check version history

Part III

10. Application for licence to operate retail pharmacy

An application for a licence to operate a retail pharmacy shall be made to the Authority using Form 17 in the Schedule to these Regulations and shall be accompanied by (a) where the business is to be carried on as a partnership, the partnership deed; (b) where the business is carried on as a body corporate, the memorandum and articles of association;

(c)

the certificate of suitability of premises; and

(d)

evidence that the pharmacist to be in charge of the pharmacy is a director or partner 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 licence to operate retail pharmacy” applies.

“An application for a licence to operate a retail pharmacy shall be made to the Authority using Form 17 in the Schedule to these Regulations and shall be accompanied by (a) where the business is to be carried on as a partnership, the partnership deed; (b) where the business is carried on as a body corporate, the memorandum and articles of association;”
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.

2
  1. (c) the certificate of suitability of premises; and
  2. (d) evidence that the pharmacist to be in charge of the pharmacy is a director or partner 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.

Authority status: legislation is primary authority; judgment weight follows the displayed court level and the ratio caveat. Check version history
11. Licence to operate retail pharmacy

The Authority shall issue a licence to operate a retail pharmacy where the applicant complies with the requirements of regulation 5 of these 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 “Licence to operate retail pharmacy”.

“The Authority shall issue a licence to operate a retail pharmacy where the applicant complies with the requirements of regulation 5 of these 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.

1
  1. The Authority shall issue a licence to operate a retail pharmacy where the applicant complies with the requirements of regulation 5 of these Regulations.
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.

Authority status: legislation is primary authority; judgment weight follows the displayed court level and the ratio caveat. Check version history
12. Dispensing of Class A and Class B drugs
(1)

The dispensing of Class A and Class B drugs shall be under the supervision of the pharmacist whose certificate of registration is submitted with the application under regulation 10.

(2)

A pharmacy shall not dispense Class A and Class B drugs when the pharmacist is not present at the pharmacy.

(3)

A Class A or Class B Group 1 drug shall not be dispensed except under a valid prescription written by a registered medical practitioner, dental surgeon or veterinary surgeon.

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 of Class A and Class B drugs”.

“(1) The dispensing of Class A and Class B drugs shall be under the supervision of the pharmacist whose certificate of registration is submitted with the application under regulation 10.”
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. (1) The dispensing of Class A and Class B drugs shall be under the supervision of the pharmacist whose certificate of registration is submitted with the application under regulation 10.
  2. (2) A pharmacy shall not dispense Class A and Class B drugs when the pharmacist is not present at the pharmacy.
  3. (3) A Class A or Class B Group 1 drug shall not be dispensed except under a valid prescription written by a registered medical practitioner, dental surgeon or veterinary surgeon.
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.

Authority status: legislation is primary authority; judgment weight follows the displayed court level and the ratio caveat. Check version history
13. Equipment for dispensing drugs
(1)

A retail pharmacy shall keep and maintain adequate equipment for the dispensing of drugs including-

(a)

sufficient balances and weights; (b) measures; (c) spatulas; (d) ointment slabs; (e) counting trays; and (f) a refrigerator.

(2)

The pharmacy shall keep and use suitable dispensing containers and labels.

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 “Equipment for dispensing drugs”.

“(1) A retail pharmacy shall keep and maintain adequate equipment for the dispensing of drugs including-”
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. (1) A retail pharmacy shall keep and maintain adequate equipment for the dispensing of drugs including-
  2. (a) sufficient balances and weights; (b) measures; (c) spatulas; (d) ointment slabs; (e) counting trays; and (f) a refrigerator.
  3. (2) The pharmacy shall keep and use suitable dispensing containers and labels.
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.

Authority status: legislation is primary authority; judgment weight follows the displayed court level and the ratio caveat. Check version history
14. Reference books
(1)

A pharmacy shall keep and maintain current editions of-

(a)

the Uganda National Formulary;

(b)

the Martindales Extra Pharmacopoeia;

(c)

the Essential Drug List for Uganda;

(d)

the list of pharmacists, medical, dental and veterinary practitioners registered to practice in Uganda; (e) the Uganda National Standards Treatment Guideline; (f) the National Drug Policy and Authority Act and the Regulations made under the Act.

(2)

A retail pharmacy shall have a prescription and patient recording system which shall consist of-

(a)

a well indexed and up to date prescription record;

(b)

a profile of the patients, maintained using a suitable and adequate computerised or other appropriate recording system;

(c)

records of the stock received, the batch number of the stock and the source of the stock; and

(d)

the date of expiry of the drugs and quantity of received drugs.

(3)

All records shall be retained for a minimum of five years.

(4)

All records shall be available for inspection by an inspector of drugs at all reasonable times.

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 “Reference books”.

“(1) A pharmacy shall keep and maintain current editions of-”
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.

12
  1. (1) A pharmacy shall keep and maintain current editions of-
  2. (a) the Uganda National Formulary;
  3. (b) the Martindales Extra Pharmacopoeia;
  4. (c) the Essential Drug List for Uganda;
  5. (d) the list of pharmacists, medical, dental and veterinary practitioners registered to practice in Uganda; (e) the Uganda National Standards Treatment Guideline; (f) the National Drug Policy and Authority Act and the Regulations made under the Act.
  6. (2) A retail pharmacy shall have a prescription and patient recording system which shall consist of-
  7. (a) a well indexed and up to date prescription record;
  8. (b) a profile of the patients, maintained using a suitable and adequate computerised or other appropriate recording system;

4 further items remain in the statutory text above.

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.

Authority status: legislation is primary authority; judgment weight follows the displayed court level and the ratio caveat. Check version history

Part IV

15. Application for licence to operate wholesale pharmacy

An application for a licence to operate a wholesale pharmacy shall be made to the Authority using Form 18 in the Schedule to these Regulations and shall be accompanied by- (a) where the business is to be carried on as a partnership, the partnership deed; (b) where the business is carried on as a body corporate, the memorandum and articles of association; (c) the certificate of suitability of premises; and

(d)

a certified copy of the certificate of registration of the pharmacist to be in charge of the pharmacy.

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 licence to operate wholesale pharmacy” applies.

“An application for a licence to operate a wholesale pharmacy shall be made to the Authority using Form 18 in the Schedule to these Regulations and shall be accompanied by- (a) where the business is to be carried on as a partnership, the partnership deed; (b) where the business is carried on as a body corporate, the memorandum and articles of association; (c) the certificate of suitability of premises; and”
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. (d) a certified copy of the certificate of registration of the pharmacist to be in charge of the pharmacy.
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.

Authority status: legislation is primary authority; judgment weight follows the displayed court level and the ratio caveat. Check version history
16. Licence to operate a wholesale pharmacy
(1)

The Authority shall issue a licence to operate a wholesale pharmacy where the applicant complies with the requirements of regulation 5 of these Regulations.

(2)

A licensed person who is issued a licence to carry on the business of supplying drugs by wholesale under section 37 of the Act shall import or supply by wholesale the Class A and Class B drugs only under the supervision of the pharmacist whose certificate of registration is submitted with the application under regulation 15.

(3)

For avoidance of doubt, a licensed person shall not sell Class A or Class B drugs where that pharmacist is not present at the pharmacy.

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 “Licence to operate a wholesale pharmacy”.

“(1) The Authority shall issue a licence to operate a wholesale pharmacy where the applicant complies with the requirements of regulation 5 of these 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.

3
  1. (1) The Authority shall issue a licence to operate a wholesale pharmacy where the applicant complies with the requirements of regulation 5 of these Regulations.
  2. (2) A licensed person who is issued a licence to carry on the business of supplying drugs by wholesale under section 37 of the Act shall import or supply by wholesale the Class A and Class B drugs only under the supervision of the pharmacist whose certificate of registration is submitted with the application under regulation 15.
  3. (3) For avoidance of doubt, a licensed person shall not sell Class A or Class B drugs where that pharmacist is not present at the pharmacy.
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.

Authority status: legislation is primary authority; judgment weight follows the displayed court level and the ratio caveat. Check version history
17. Records of wholesale pharmacies
(1)

A wholesale pharmacy shall keep for Class A or Class B drugs the following-

(a)

receipts, records of the suppliers and quantities of the drugs, the batch numbers, dates of expiry of the drugs, and date of importation and the verification certificate, where the drugs are imported;

(b)

for the sales made, the persons to whom drugs are supplied, the quantity supplied, the batch number and date of expiry of the drugs; and

(c)

up-to-date records of the stock on hand for each batch and consignment.

(2)

The records of the drugs that are rejected or expired shall be kept for a minimum of five years.

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 “Records of wholesale pharmacies”.

“(1) A wholesale pharmacy shall keep for Class A or Class B drugs the following-”
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.

5
  1. (1) A wholesale pharmacy shall keep for Class A or Class B drugs the following-
  2. (a) receipts, records of the suppliers and quantities of the drugs, the batch numbers, dates of expiry of the drugs, and date of importation and the verification certificate, where the drugs are imported;
  3. (b) for the sales made, the persons to whom drugs are supplied, the quantity supplied, the batch number and date of expiry of the drugs; and
  4. (c) up-to-date records of the stock on hand for each batch and consignment.
  5. (2) The records of the drugs that are rejected or expired shall be kept for a minimum of five years.
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.

Authority status: legislation is primary authority; judgment weight follows the displayed court level and the ratio caveat. Check version history

Part V

18. Application for licence to manufacture drugs
(1)

An application for a licence to manufacture drugs shall be made using Form 19 in the Schedule to these Regulations.

(2)

The application shall be accompanied by- (a) a certified copy of the certificate of registration of the pharmacist to be in charge of the manufacturing process; (b) a list of the drugs to be manufactured and proof of registration of the drugs;

(c)

the certificates of qualification of the key personnel to be involved in the manufacturing process, as may be determined by the Authority;

(d)

a certificate of compliance with the internationally accepted Good Manufacturing Practice Guidelines adopted by the Authority; and

(e)

the prescribed fees.

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 licence to manufacture drugs” applies.

“(1) An application for a licence to manufacture drugs shall be made using Form 19 in the Schedule to these Regulations.”
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.

5
  1. (1) An application for a licence to manufacture drugs shall be made using Form 19 in the Schedule to these Regulations.
  2. (2) The application shall be accompanied by- (a) a certified copy of the certificate of registration of the pharmacist to be in charge of the manufacturing process; (b) a list of the drugs to be manufactured and proof of registration of the drugs;
  3. (c) the certificates of qualification of the key personnel to be involved in the manufacturing process, as may be determined by the Authority;
  4. (d) a certificate of compliance with the internationally accepted Good Manufacturing Practice Guidelines adopted by the Authority; and
  5. (e) the prescribed fees.
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.

Authority status: legislation is primary authority; judgment weight follows the displayed court level and the ratio caveat. Check version history
19. Good Manufacturing Practice Guidelines
(1)

The Authority shall, for the purposes of assessing the manufacturing practices of the manufacturer, adopt with the necessary modifications, internationally accepted Good Manufacturing Practice Guidelines.

(2)

A manufacturer who manufactures drugs in Uganda or outside Uganda for importation into Uganda shall comply with the Good Manufacturing Practice Guidelines adopted by the Authority.

(3)

The manufacturer shall, prior to manufacturing drugs or importation of drugs, as the case may be, make an application to the Authority for assessment of the facility to be used for manufacturing drugs, for compliance with Good Manufacturing Practice Guidelines.

(4)

An application for assessment for compliance with Good Manufacturing Practice Guidelines shall be made using Form 20 in the Schedule to these Regulations.

(5)

Where a manufacturer complies with the Good Manufacturing Practice Guidelines, the Authority shall issue to the manufacturer a certificate of compliance with Good Manufacturing Practice Guidelines in Form 21 in the Schedule to these 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 “Good Manufacturing Practice Guidelines”.

“(1) The Authority shall, for the purposes of assessing the manufacturing practices of the manufacturer, adopt with the necessary modifications, internationally accepted Good Manufacturing Practice Guidelines.”
Primary legislation Source quotation matched
Practical effect

The power must be exercised by the authorised decision-maker, within the conditions and purpose stated in the section.

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

Operative requirements extracted from the consolidated text.

5
  1. (1) The Authority shall, for the purposes of assessing the manufacturing practices of the manufacturer, adopt with the necessary modifications, internationally accepted Good Manufacturing Practice Guidelines.
  2. (2) A manufacturer who manufactures drugs in Uganda or outside Uganda for importation into Uganda shall comply with the Good Manufacturing Practice Guidelines adopted by the Authority.
  3. (3) The manufacturer shall, prior to manufacturing drugs or importation of drugs, as the case may be, make an application to the Authority for assessment of the facility to be used for manufacturing drugs, for compliance with Good Manufacturing Practice Guidelines.
  4. (4) An application for assessment for compliance with Good Manufacturing Practice Guidelines shall be made using Form 20 in the Schedule to these Regulations.
  5. (5) Where a manufacturer complies with the Good Manufacturing Practice Guidelines, the Authority shall issue to the manufacturer a certificate of compliance with Good Manufacturing Practice Guidelines in Form 21 in the Schedule to these Regulations.
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.

Authority status: legislation is primary authority; judgment weight follows the displayed court level and the ratio caveat. Check version history
20. Persons authorised to supervise the manufacture of drugs
(1)

The manufacturing process shall be carried out by a suitably qualified pharmacist.

(2)

The manufacturing process shall be supervised by the pharmacist whose registration is submitted with the application in regulation 18 (2).

(3)

The process of quality control and quality assurance shall be under the supervision of a registered pharmacist and shall be conducted by a team of qualified pharmacists 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 “Persons authorised to supervise the manufacture of drugs”.

“(1) The manufacturing process shall be carried out by a suitably qualified pharmacist.”
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
  1. (1) The manufacturing process shall be carried out by a suitably qualified pharmacist.
  2. (2) The manufacturing process shall be supervised by the pharmacist whose registration is submitted with the application in regulation 18 (2).
  3. (3) The process of quality control and quality assurance shall be under the supervision of a registered pharmacist and shall be conducted by a team of qualified pharmacists 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.

Authority status: legislation is primary authority; judgment weight follows the displayed court level and the ratio caveat. Check version history
21. Administration of manufacturing process
(1)

A pharmacist who is in charge of the manufacturing process shall not be in charge of the quality control and quality assurance process. (2) The pharmacist in charge of the manufacturing process and the pharmacist in charge of quality control and quality assurance shall be independent of each other.

(3)

The personnel involved in the manufacturing of drugs shall undergo a medical check-up to determine that they do not suffer from any contagious disease which may be transmitted during the manufacturing process. (4) A person issued with a licence to manufacture drugs, shall provide the personnel involved in the manufacturing process with appropriate personal protective clothing.

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 “Administration of manufacturing process”.

“(1) A pharmacist who is in charge of the manufacturing process shall not be in charge of the quality control and quality assurance process. (2) The pharmacist in charge of the manufacturing process and the pharmacist in charge of quality control and quality assurance shall be independent of each other.”
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.

2
  1. (1) A pharmacist who is in charge of the manufacturing process shall not be in charge of the quality control and quality assurance process. (2) The pharmacist in charge of the manufacturing process and the pharmacist in charge of quality control and quality assurance shall be independent of each other.
  2. (3) The personnel involved in the manufacturing of drugs shall undergo a medical check-up to determine that they do not suffer from any contagious disease which may be transmitted during the manufacturing process. (4) A person issued with a licence to manufacture drugs, shall provide the personnel involved in the manufacturing process with appropriate personal protective clothing.
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.

Authority status: legislation is primary authority; judgment weight follows the displayed court level and the ratio caveat. Check version history
22. Records to be kept by manufacturer
(1)

A person who manufactures drugs shall keep-

(a)

the records of the batches of the starting materials and ingredients, which shall indicate the source, batch numbers and the dates of expiry of the starting materials and ingredients and which shall include the certificates of analysis;

(b)

the records of each batch of manufactured drug including the master formula, the batch manufacturing records and the batch processing records;

(c)

samples of the starting materials and samples of each batch of manufactured drug, for six months after the expiry date;

(d)

the analytical and quality control results, records of supplies made to the customers and records of the quantities and batch numbers supplied on specified dates; and

(e)

other records relevant to the manufacturing process.

(2)

Except where expressly specified, all records shall be kept for a minimum of five years and shall be available for inspection by the inspector of drugs at all reasonable times.

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 “Records to be kept by manufacturer”.

“(1) A person who manufactures drugs shall keep-”
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.

7
  1. (1) A person who manufactures drugs shall keep-
  2. (a) the records of the batches of the starting materials and ingredients, which shall indicate the source, batch numbers and the dates of expiry of the starting materials and ingredients and which shall include the certificates of analysis;
  3. (b) the records of each batch of manufactured drug including the master formula, the batch manufacturing records and the batch processing records;
  4. (c) samples of the starting materials and samples of each batch of manufactured drug, for six months after the expiry date;
  5. (d) the analytical and quality control results, records of supplies made to the customers and records of the quantities and batch numbers supplied on specified dates; and
  6. (e) other records relevant to the manufacturing process.
  7. (2) Except where expressly specified, all records shall be kept for a minimum of five years and shall be available for inspection by the inspector of drugs at all reasonable times.
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.

Authority status: legislation is primary authority; judgment weight follows the displayed court level and the ratio caveat. Check version history
23. Quality control and quality assurance
(1)

The batches of the starting materials shall be tested to determine that they comply with the prescribed standards. (2) A manufacturer shall have facilities for quality control testing with the necessary equipment and reagents for carrying out the prescribed tests for the raw materials, packaging materials, in process materials and finished products.

(3)

A manufacturer may, with the approval of the Authority, use facilities outside the facilities of the manufacturer for quality control testing.

(4)

For the products which are manufactured to a set standard of a recognised pharmacopoeia or pharmaceutical codex and which are so labelled, the tests and standards prescribed in the relevant monograph shall be carried out and the results recorded. (5) The manufacturer of classified drugs shall minimise or where possible, eliminate the possibility of cross contamination of products during the manufacturing process.

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 “Quality control and quality assurance”.

“(1) The batches of the starting materials shall be tested to determine that they comply with the prescribed standards. (2) A manufacturer shall have facilities for quality control testing with the necessary equipment and reagents for carrying out the prescribed tests for the raw materials, packaging materials, in process materials and finished 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.

3
  1. (1) The batches of the starting materials shall be tested to determine that they comply with the prescribed standards. (2) A manufacturer shall have facilities for quality control testing with the necessary equipment and reagents for carrying out the prescribed tests for the raw materials, packaging materials, in process materials and finished products.
  2. (3) A manufacturer may, with the approval of the Authority, use facilities outside the facilities of the manufacturer for quality control testing.
  3. (4) For the products which are manufactured to a set standard of a recognised pharmacopoeia or pharmaceutical codex and which are so labelled, the tests and standards prescribed in the relevant monograph shall be carried out and the results recorded. (5) The manufacturer of classified drugs shall minimise or where possible, eliminate the possibility of cross contamination of products during the manufacturing process.
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.

Authority status: legislation is primary authority; judgment weight follows the displayed court level and the ratio caveat. Check version history

Part VI

24. Validity and conditions of licences and certificates
(1)

A licence and a certificate issued under these Regulations, as the case may be, shall, unless cancelled by the Authority, remain valid for the period stated in the licence or certificate. (2) A licence and a certificate shall indicate the conditions under which the licence or certificate is issued and shall state that the licence or certificate may be cancelled where the conditions are not fulfilled or are breached.

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 “Validity and conditions of licences and certificates”.

“(1) A licence and a certificate issued under these Regulations, as the case may be, shall, unless cancelled by the Authority, remain valid for the period stated in the licence or certificate. (2) A licence and a certificate shall indicate the conditions under which the licence or certificate is issued and shall state that the licence or certificate may be cancelled where the conditions are not fulfilled or are breached.”
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. (1) A licence and a certificate issued under these Regulations, as the case may be, shall, unless cancelled by the Authority, remain valid for the period stated in the licence or certificate. (2) A licence and a certificate shall indicate the conditions under which the licence or certificate is issued and shall state that the licence or certificate may be cancelled where the conditions are not fulfilled or are breached.
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.

Authority status: legislation is primary authority; judgment weight follows the displayed court level and the ratio caveat. Check version history
25. Renewal of licence
(1)

A person who wishes to renew a licence or certificate issued under these Regulations, as the case may be, shall make an application for renewal of the licence to the Authority. (2) An application for renewal of a licence or a certificate shall be made to the Authority, at least three months before the expiry of the licence or certificate for the local manufacturer and six months for the foreign manufacturer respectively. (3) The requirements and procedure for renewal of a licence or certificate shall be the same as the requirements and procedure for application of the licence or certificate.

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 “Renewal of licence”.

“(1) A person who wishes to renew a licence or certificate issued under these Regulations, as the case may be, shall make an application for renewal of the licence to the Authority. (2) An application for renewal of a licence or a certificate shall be made to the Authority, at least three months before the expiry of the licence or certificate for the local manufacturer and six months for the foreign manufacturer respectively. (3) The requirements and procedure for renewal of a licence or certificate shall be the…”
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. (1) A person who wishes to renew a licence or certificate issued under these Regulations, as the case may be, shall make an application for renewal of the licence to the Authority. (2) An application for renewal of a licence or a certificate shall be made to the Authority, at least three months before the expiry of the licence or certificate for the local manufacturer and six months for the foreign manufacturer respectively. (3) The requirements and procedure for renewal of a licence or certificate shall be the same as the requirements and procedure for application of the licence or certificate.
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.

Authority status: legislation is primary authority; judgment weight follows the displayed court level and the ratio caveat. Check version history
26. Suspension and revocation of licences and certificates
(1)

The Authority may suspend or revoke a licence or a certificate issued under these Regulations where-

(a)

the person granted the licence or a certificate contravenes a provision of the Act or of any other applicable law or breaches a condition of the licence or certificate;

(b)

the person granted the licence or certificate fails to remedy a contravention of the Act or repeats a contravention of the Act or of a condition of the licence or certificate; or

(c)

the person to whom the licence or certificate is granted, as the case may be ceases to be fit to carry on the business for which the licence or certificate is granted.

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 “Suspension and revocation of licences and certificates”.

“(1) The Authority may suspend or revoke a licence or a certificate issued under these Regulations where-”
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.

4
  1. (1) The Authority may suspend or revoke a licence or a certificate issued under these Regulations where-
  2. (a) the person granted the licence or a certificate contravenes a provision of the Act or of any other applicable law or breaches a condition of the licence or certificate;
  3. (b) the person granted the licence or certificate fails to remedy a contravention of the Act or repeats a contravention of the Act or of a condition of the licence or certificate; or
  4. (c) the person to whom the licence or certificate is granted, as the case may be ceases to be fit to carry on the business for which the licence or certificate is granted.
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.

Authority status: legislation is primary authority; judgment weight follows the displayed court level and the ratio caveat. Check version history

Part VII

27. Delivery of drugs
(1)

A delivery of drugs shall only be made to a customer on the basis of previously placed orders.

(2)

A licensed person and a licensed seller shall not sell drugs from a delivery vehicle.

(3)

For avoidance of doubt, hawking of drugs is prohibited.

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 “Delivery of drugs”.

“(1) A delivery of drugs shall only be made to a customer on the basis of previously placed orders.”
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. (1) A delivery of drugs shall only be made to a customer on the basis of previously placed orders.
  2. (2) A licensed person and a licensed seller shall not sell drugs from a delivery vehicle.
  3. (3) For avoidance of doubt, hawking of drugs is prohibited.
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.

Authority status: legislation is primary authority; judgment weight follows the displayed court level and the ratio caveat. Check version history
28. Notification of change in ownership
(1)

Where there is a change in the ownership of the business, the person to whom the licence is issued under these Regulations shall, within thirty days of the change, notify the Authority.

(2)

The person to whom a licence is issued under these Regulations shall submit to the Authority, a certified copy of the articles of association or partnership deed reflecting the change.

(3)

Where a licensed person or a licensed seller ceases to be responsible for the business for which the licence is issued before the expiry of the licence, the licensed person or licensed seller, as the case may be, shall return the licence to 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 “Notification of change in ownership”.

“(1) Where there is a change in the ownership of the business, the person to whom the licence is issued under these Regulations shall, within thirty days of the change, notify 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.

3
  1. (1) Where there is a change in the ownership of the business, the person to whom the licence is issued under these Regulations shall, within thirty days of the change, notify the Authority.
  2. (2) The person to whom a licence is issued under these Regulations shall submit to the Authority, a certified copy of the articles of association or partnership deed reflecting the change.
  3. (3) Where a licensed person or a licensed seller ceases to be responsible for the business for which the licence is issued before the expiry of the licence, the licensed person or licensed seller, as the case may be, shall return the licence to 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.

Authority status: legislation is primary authority; judgment weight follows the displayed court level and the ratio caveat. Check version history
29. Compliance with other requirements

A licensed person and a licensed seller shall comply with any other requirements as may be specified 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 other requirements”.

“A licensed person and a licensed seller shall comply with any other requirements as may be specified 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
  1. A licensed person and a licensed seller shall comply with any other requirements as may be specified 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.

Authority status: legislation is primary authority; judgment weight follows the displayed court level and the ratio caveat. Check version history
30. Display of signposts

The premises, in respect of which a licence is issued by the Authority, shall have a conspicuous signpost indicating the name and type of business carried out at the premises.

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 “Display of signposts”.

“The premises, in respect of which a licence is issued by the Authority, shall have a conspicuous signpost indicating the name and type of business carried out at the premises.”
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 premises, in respect of which a licence is issued by the Authority, shall have a conspicuous signpost indicating the name and type of business carried out at the premises.
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.

Authority status: legislation is primary authority; judgment weight follows the displayed court level and the ratio caveat. Check version history
31. Revocation of S.I 206 - 3 and regulation 16 of S.I 206-1
(1)

The National Drug Policy and Authority (Issue of Licences) Regulations, S.I 206- 3 is revoked.

(2)

Regulation 16 of SI 206 - 1 is revoked.

SCHEDULE

FORMS

FORM 16 Regulations 4(2)

Application for a Licence to Sell Class C Drugs

Physical address of premises _____________________________________ P. O. Box No. ______________ Tel. ______________ Fax ______________ Name of applicant _________________________________________ Qualifications-(pharmaceutical) __________________________________ (Other) ______________________________________________________

Is the application made for- (a) an individual ____________________________________________ (b) a partnership ___________________________________________ (c) a company ______________________________________________ (tick as appropriate)

If applying on behalf of a company- Physical address of registered office__________________________________ P.O. Box No._____________ Tel. _______________ Fax _______________ Name of managing director ________________________________________

If applying on behalf of a company or partnership, give the following information for all partners or directors- Name _________________________________________________________ Address________________________________________________________ Qualification____________________________________________________

Has the applicant or any partner or director been convicted, of any offence involving the wrongful or illegal dealing or supply or possession of drugs within or outside Uganda? Yes/No If "yes", give details ______________________________________________ Has any previous application by the applicant, or any partner or director, for a licence to operate any type of business under the Act been refused or cancelled? Yes/No

If "yes", give details ______________________________________________

Does the applicant or any partner or director currently hold a licence to operate any type of business under the Act, including the business of selling class C drugs, at any other premises? Yes/No

If "yes", give details _____________________________________________ Name of person to be in charge of the premises ________________________ Qualification/training ____________________________________________

I have been informed of and understand the restrictions on the range of drugs and drugs which may be sold by a class C drug shop.

I certify that the above information is correct and apply for a licence to sell Class C drugs at the above-named premises.

Signature of applicant ________________ Date _______________

For Authority use:

Suitability of premises certificate checked Yes/No ______________________

Applicant's information checked and verified Yes/No ___________________________________________________ (signature)

Licence to operate a class C drug shop for selling of drugs included in the Third Schedule of the Act.

Approved/not approved ___________________________________________

If not approved, give reasons _______________________________________

________________________________ __________________________ _ For the Authority Date

FORM 17.

Regulations 10

Application For a Licence to Operate Retail Pharmacy.

Physical address of premises ____________________________________ P.O. Box No. ______________ Tel. ______________ Fax ______________ Name of applicant _______________________________________________ Qualifications- (pharmaceutical) ________________________________________________ (Other) _______________________________________________________ Application is made fora partnership ____________________________________________________ a company _____________________________________________________

If applying on behalf of a company- Physical address of registered office_________________________________ P.O. Box No. _____________ Tel. _______________ Fax ______________

Name of managing director ________________________________________ If applying on behalf of a company or partnership, give the following information for all directors or partners - Name__________________________________________________________

Address________________________________________________________

Qualifications___________________________________________________ Has the applicant or any partner or director been convicted , of any offence involving the wrongful or illegal dealing in or supply or possession of drugs within or outside Uganda? Yes/No If "yes", give details _____________________________________________

Has any previous application by the applicant, or any partner or director, for a licence to operate any type of business under the Act, including the business of selling class C drugs, been refused or cancelled? Yes/No If "yes", give details ______________________________________________

Purposes for which premises are to be used (tick proposed activities)- retail pharmacy __________________________________________________ dispensing prescriptions ___________________________________________ compounding for prescription ______________________________________ compounding for retail sale ________________________________________ packing ________________________________________________________ Name and registration number of pharmacist to be in charge of the premises _____________________________________________________________

I certify that the above information is correct and apply for a licence to operate retail pharmacy at the above-named premises.

Signature of applicant_____________________________________________ Date_________________________________________________________

For Authority use:

Suitability of premises certificate checked Yes/No

____________________________________________________ (signature)

Applicant's information checked and verified Yes/No ___________________ Licence to operate a retail pharmacy approved/not approved

If not approved, give reasons _______________________________________

________________________________ _________________________ For the Authority Date

FORM 18.

Regulations 15

Application for a Licence to Operate Wholesale Pharmacy.

Physical address of premises ______________________________________ P. O. Box No. _______________ Tel. _____________ Fax ______________ Name of applicant _______________________________________________ Qualifications - (pharmaceutical) ________________________________________________ (Other) ________________________________________________________

Is the application made fora partnership ____________________________________________________ a company _____________________________________________________

If applying on behalf of a company__________________________________ Physical address of registered office________________________________ P. O. Box No. _______________ Tel. _______________ Fax ____________ Name of managing director __________________________________

If applying on behalf of a company or partnership, give the following information for all the directors or partners -

Name_________________________________________________________ Address________________________________________________________ Qualifications___________________________________________________

Has the applicant or any partner or director been convicted, of any offence involving the wrongful or illegal dealing in or supply or possession of drugs within or outside Uganda? Yes/No

If "yes", give details ____________________________________________

Has any previous application by the applicant or any partner or director for a licence to operate any type of business under the Act, including the business of selling class C drugs, been refused or cancelled? Yes/No

If "yes", give details ______________________________________________

Will a retail pharmacy be operated from the same premises? Yes/No

Does the applicant or any partner or director currently hold a licence to operate any type of business under the Act, including the business of selling class C drugs, at any other premises? Yes/No

Will the licensed person import drugs from outside Uganda? Yes/No

Will the business sell human drugs/veterinary drugs/both? Name and registration number of pharmacist to be in charge of the business _______________________________________________________________

I certify that the above information is correct and apply for a licence to operate a wholesale pharmacy at the above-named premises.

Signature of applicant____________________________________________ Date__________________________________________________________

__________________________________ __________________________ For the Authority Date

FORM 19.

Regulation 18 (1)

Application For a Licence to Manufacture Drugs

Physical address of premises _______________________________________ P. O. Box No. _______________ Tel. ______________ Fax _____________ Name of applicant ___________________________________________ Qualifications (pharmaceutical) ___________________________________ (Other) ______________________________________________________

Is the application made fora partnership ____________________________________________________ a company _____________________________________________________

If applying on behalf of a company-

Physical address of registered office ________________________________ P. O. Box No. _______________ Tel. ______________ Fax _____________ Name of managing director ________________________________________

If applying on behalf of a company or partnership give the following information for all partners or directors-

Name__________________________________________________________

Address________________________________________________________

Qualifications___________________________________________________ Has the applicant or any partner or director been convicted, of any offence involving the wrongful or illegal dealing in or supply or possession of drugs within or outside Uganda? Yes/No

If "yes", give details ____________________________________________

Has any previous application by the applicant, or any partner or director, for a licence to operate any type of business under the Act been refused or cancelled? Yes/No

If "yes", give details ______________________________________________

Does the applicant or any partner or director currently hold a licence to operate any type of business under the Act, including the business of selling class C drugs, at any other premises? Yes/No

If "yes", give details ______________________________________________

Name and registration number of the pharmacist in charge of the manufacturing processes _________________________________________

Name and registration number of pharmacist or name of the chemist to be in charge of quality control and assurance _______________________________

Names, qualifications and registration number of the other pharmacists employed and names of the other or chemists employed _________________

I certify that the above information is correct and apply for a licence to manufacture drugs at the above-named premises.

______________________________ _____________________ Signature of applicant Date

For Authority use:

Suitability of premises certificated checkedYes/No

____________________________________________________ (Signature)

Applicant's information checked and verified Yes/No _____________________________________________________ (Signature)

Licence to manufacture drugs approved/not approved If not approved, give reasons _______________________________________.

_____________________________ ___________________________ For Authority Date

FORM 20 Regulations 19 (4)

Application for Assessment for Compliance with Good Manufacturing Practice Guidelines

(A separate application form should be filled for each site)

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
Offence or consequence

This section creates or governs statutory liability concerning “Revocation of S.I 206 - 3 and regulation 16 of S.I 206-1”.

“(1) The National Drug Policy and Authority (Issue of Licences) Regulations, S.I 206- 3 is revoked.”
Primary legislation Source quotation matched
Practical effect

A party alleging or defending liability should test the facts and prescribed consequence against each operative requirement.

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. (1) The National Drug Policy and Authority (Issue of Licences) Regulations, S.I 206- 3 is revoked.
  2. (2) Regulation 16 of SI 206 - 1 is revoked.
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.

Authority status: legislation is primary authority; judgment weight follows the displayed court level and the ratio caveat. Check version history
1. Particulars of applicant/licence holder

Name_____________________________________________________ Physical Address____________________________________________ Country__________________Telephone_________________________ Fax________________E-mail_________________________________

2. Particulars of site to be inspected

Name of manufacturing site________________________________ Physical address (if different from number 1) Country_____________________Tel___________________________ Fax_________________E-mail:_______________________________

3. Contact person at manufacturing site

Name of contact person_______________________________________ Tel:__________________________Fax:_________________________ E-mail:___________________________________________________

4. Type of drugs manufactured (Tick where applicable)
(a)

Human only (b) veterinary only (c) human & veterinary

5. Inspection type (Please tick where applicable)
(a)

First inspection (b) Routine re- inspection (previous inspection date…………………) (c) Re-inspection after failure …………………………………….... (d) Other (please specify)……………………………………………

6. Lines to be inspected

Tick where Dosage form *category **activities applicable Tablets Capsules Injections (SVP)# Injections (LVP) # Oral liquids Powders for oral suspension Creams/Ointments/lotions Others (specify)

*Category means, Beta lactam (Penicillin), Beta lactam (Cephalosporins), Non-beta lactam, Biologicals, Vaccines, Hormones, Cytotoxic products.

**Activity means any step in the manufacturing process that is conducted at the site such as the complete manufacture of dosage form, primary or secondary packaging, quality control and warehousing. # Small Volume Parenterals (SVP) refers to packs of 100ml or less and Large Volume Parenterals (LVP) are packs of more than 100ml.

7. Registration of drugs

Has the applicant applied for registration of the drugs? Yes 1 No 1 If yes, list the drugs. (Attach a separate sheet if needed) …………….

8. Inspection dates

In order to schedule an inspection, the applicant should indicate an approximate date from which the applicant may be ready for the inspection. If this date changes after the application is submitted, the applicant shall notify the Authority as soon as possible.

Approximate date when the facility is to ready for inspection ……/…../…… (For re-inspections, not more than three months after expiry of GMP validity) The actual date of the audit will be advised to the applicant by the Authority.

Site master file It is requested that the applicant encloses with this application form a copy of the site master file (not more than 25 pages). Enclosed -Yes 1 No 1

I hereby certify that the above information is correct and apply for Good Manufacturing Practice inspection of the above-named site or sites.

Signature of applicant………………………. Date……………………………

Name of applicant……………………………………………………………..

FORM 21 Regulation 19 (5)

Certificate of Compliance with Good Manufacturing Practice Guidelines

The National Drug Policy and Authority Act, Cap 206

Certificate No. ……………………

This is to certify that the drug manufacturing facility: Name of facility _________________________________________________ Physical address of facility _________________________________________ Licence number of the manufacturer ________________________________ Has been inspected by the Authority for compliance with the Good Manufacturing Practice Guidelines.

On the basis of the inspection carried out ____________ [dd/mm/yyyy], it is certified that the facility indicated on this certificate complies with Good Manufacturing Practice for dosage forms listed in Table 1 below.

Table 1: Approved lines No. Dosage form Category Activities

1. 2

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

3. The responsibility for the quality of

the individual batches of the drugs manufactured through this process lies with the manufacturer This certificate remains valid until ________________ [dd/mm/yyyy]. It becomes invalid if the activities or the categories certified change or if the facility is no longer considered to be in compliance with GMP.

………………………………………. For the Authority RUHAKANA RUGUNDA (DR.), Minister of Health.

Original Laws of Uganda consolidation (as at 28 March 2014) — public-domain legislation, consolidated by ULII / Laws.Africa (CC BY 4.0). This is a point-in-time text and may not reflect later amendments; confirm against the latest Uganda Gazette before relying on it.