National Drug Policy and Authority (Importation and Exportation of Drugs) Regulations

1. Title

These Regulations may be cited as the National Drug Policy and Authority (Importation and Exportation of Drugs) 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 (Importation and Exportation of Drugs) Regulations, 2014.”

Primary legislation Source quotation matched

Practical effect

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

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

Elements or requirements

Operative requirements extracted from the consolidated text.

1

These Regulations may be cited as the National Drug Policy and Authority (Importation and Exportation of Drugs) Regulations, 2014.

Judicial interpretation

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

0

No judgment in the current Wakilii corpus expressly cites this section. Bare rule-number references are not assigned where the Order cannot be verified.

Related provisions

No express internal or cross-Act reference appears in this section.

Amendment notes

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

2. Interpretation

In these Regulations, unless the context otherwise requires- "Act" means the National Drug Policy and Authority Act; "Authority" means the National Drug Authority; "drug" means any substance or preparation used or intended to be used for internal or external application to the human or animal body either in the treatment or prevention of disease or for improving physiological functions, or for agricultural or industrial purposes.

Section analysis Source-linked statutory analysis Source linked

Approved statute annotation. Statutory quotations are matched to this consolidation and judicial passages are linked to judgments. Check the primary sources alongside this analysis.

What this section does

Definition

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

“In these Regulations, unless the context otherwise requires- "Act" means the National Drug Policy and Authority Act; "Authority" means the National Drug Authority; "drug" means any substance or preparation used or intended to be used for internal or external application to the human or animal body either in the treatment or prevention of disease or for improving physiological functions, or for agricultural or industrial purposes.”

Primary legislation Source quotation matched

Practical effect

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

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

Elements or requirements

Operative requirements extracted from the consolidated text.

1

In these Regulations, unless the context otherwise requires- "Act" means the National Drug Policy and Authority Act; "Authority" means the National Drug Authority; "drug" means any substance or preparation used or intended to be used for internal or external application to the human or animal body either in the treatment or prevention of disease or for improving physiological functions, or for agricultural or industrial purposes.

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.

3. Importation of drugs

(1)

A person shall not import drugs into Uganda, without an import licence issued by the Authority.

(2)

An import licence shall be in the format prescribed in Form 22 in the Schedule to these Regulations.

(3)

The Authority shall issue an import licence where it is satisfied that the applicant meets the criteria set out in this Part.

(4)

A licence shall be valid during the calendar year in which it is issued.

(5)

The Authority shall prior to issuing an import licence, ascertain that the facility from which the drugs to be imported, are manufactured, complies with the internationally accepted Good Manufacturing Practice Guidelines adopted 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 “Importation of drugs”.

“(1) A person shall not import drugs into Uganda, without an import licence issued 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.

5

(1) A person shall not import drugs into Uganda, without an import licence issued by the Authority.
(2) An import licence shall be in the format prescribed in Form 22 in the Schedule to these Regulations.
(3) The Authority shall issue an import licence where it is satisfied that the applicant meets the criteria set out in this Part.
(4) A licence shall be valid during the calendar year in which it is issued.
(5) The Authority shall prior to issuing an import licence, ascertain that the facility from which the drugs to be imported, are manufactured, complies with the internationally accepted Good Manufacturing Practice Guidelines adopted 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.

4. Application for import licence

(1)

An application for a licence to import drugs shall be made using Form 23 in the Schedule to these Regulations and shall be accompanied by the licence of the licensed person and the prescribed fees.

(2)

An application for a licence to import drugs shall be made by a licensed person.

(3)

An import licence may be cancelled where the licence issued to a licensed person to operate a retail or wholesale pharmacy or to manufacture drugs is cancelled 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

Scope rule

This section defines when and how “Application for import licence” applies.

“(1) An application for a licence to import drugs shall be made using Form 23 in the Schedule to these Regulations and shall be accompanied by the licence of the licensed person and the prescribed fees.”

Primary legislation Source quotation matched

Practical effect

Confirm that the matter and forum fall within this section before applying the Act's remaining provisions.

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

Elements or requirements

Operative requirements extracted from the consolidated text.

3

(1) An application for a licence to import drugs shall be made using Form 23 in the Schedule to these Regulations and shall be accompanied by the licence of the licensed person and the prescribed fees.
(2) An application for a licence to import drugs shall be made by a licensed person.
(3) An import licence may be cancelled where the licence issued to a licensed person to operate a retail or wholesale pharmacy or to manufacture drugs is cancelled 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.

5. Authorisation for importation of narcotic drugs and

psychotropic substances. (1) A person shall not import narcotic drugs or psychotropic substances without a permit issued by the Authority.

(2)

The permit shall be in the format prescribed in Form 24 in the Schedule to these Regulations.

(3)

An application for permit shall be made by a person issued with an import licence under regulation 3.

(4)

Where the application is made by a manufacturer of a drug, the applicant shall furnish the Authority with evidence showing that the reason for the importation of the narcotic drug or psychotropic substances is for the use of the narcotic drug or psychotropic substances as a raw material for the manufacture of a finished or intermediate drug.

(5)

An applicant shall furnish the Authority with evidence showing that the narcotic drug or psychotropic substances shall be sold in accordance with the requirements of the Act.

(6)

A person authorised to import a narcotic drug or psychotropic substances shall, within 30 days from the date of receipt of the drugs, make returns to the Authority and shall after the importation, hand over the permit to the Authority.

(7)

The importation of narcotic drugs and psychotropic substances shall be in accordance with 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 “Authorisation for importation of narcotic drugs and”.

“psychotropic substances. (1) A person shall not import narcotic drugs or psychotropic substances without a permit issued 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.

6

(2) The permit shall be in the format prescribed in Form 24 in the Schedule to these Regulations.
(3) An application for permit shall be made by a person issued with an import licence under regulation 3.
(4) Where the application is made by a manufacturer of a drug, the applicant shall furnish the Authority with evidence showing that the reason for the importation of the narcotic drug or psychotropic substances is for the use of the narcotic drug or psychotropic substances as a raw material for the manufacture of a finished or intermediate drug.
(5) An applicant shall furnish the Authority with evidence showing that the narcotic drug or psychotropic substances shall be sold in accordance with the requirements of the Act.
(6) A person authorised to import a narcotic drug or psychotropic substances shall, within 30 days from the date of receipt of the drugs, make returns to the Authority and shall after the importation, hand over the permit to the Authority.
(7) The importation of narcotic drugs and psychotropic substances shall be in accordance with 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.

6. Verification certificate

(1)

A consignment of drugs to be imported into Uganda shall before importation, be issued with a verification certificate which shall be in the format in Form 25 in the Schedule to these Regulations.

(2)

A licensed person shall before the importation of a consignment of drugs into Uganda apply for a verification certificate using Form 26 in the Schedule to these Regulations.

(3)

An application for a verification certificate, for each drug to be imported shall state- (a) the generic name of the drug and its strength, and in the case of a drug containing more than one active ingredient, the name and strength of each active ingredient; (b) the pharmacopoeial specification of the ingredient such as the B.P. U.S.P; (c) the total quantity of the drug to be imported;

(d)

the name of the manufacturer or supplier of the drugs; (e) the country of origin of the drug; (f) the proprietary name of the drug, where applicable; and (g) the registration number of the 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

Mandatory duty

This section imposes mandatory requirements concerning “Verification certificate”.

“(1) A consignment of drugs to be imported into Uganda shall before importation, be issued with a verification certificate which shall be in the format in Form 25 in the Schedule to these Regulations.”

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.

4

(1) A consignment of drugs to be imported into Uganda shall before importation, be issued with a verification certificate which shall be in the format in Form 25 in the Schedule to these Regulations.
(2) A licensed person shall before the importation of a consignment of drugs into Uganda apply for a verification certificate using Form 26 in the Schedule to these Regulations.
(3) An application for a verification certificate, for each drug to be imported shall state- (a) the generic name of the drug and its strength, and in the case of a drug containing more than one active ingredient, the name and strength of each active ingredient; (b) the pharmacopoeial specification of the ingredient such as the B.P. U.S.P; (c) the total quantity of the drug to be imported;
(d) the name of the manufacturer or supplier of the drugs; (e) the country of origin of the drug; (f) the proprietary name of the drug, where applicable; and (g) the registration number of the 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.

7. Packaging for imported drugs

(1)

The primary packaging of an imported drug shall be clearly labelled in English with the following- (a) the trade or brand name, where appropriate;

(b)

the generic name of the drug;

(c)

the quantities of active ingredients in the drug;

(d)

the dates of manufacture and expiry of the drug;

(e)

the batch or lot number of the drug;

(f)

any special conditions of storage applicable to the drug;

(g)

the name and address of the manufacturer of the drug;

(h)

a unique identification feature, if any; and

(i)

the registration number of the drug, where applicable.

(2)

The information leaflet enclosed in or accompanying the imported drug shall be in English.

(3)

A drug labelled "for sale only in specified countries" shall not be imported into Uganda except where Uganda is one of the specified countries.

(4)

Notwithstanding subregulation (3), the Authority may, in special circumstances, authorise the importation of drugs referred to in the subregulation into Uganda.

(5)

Where the label of a drug show evidence of alteration in the label, the drug shall be deemed to be adulterated and shall not be allowed entry into Uganda or shall be returned to the manufacturer at the cost of the person who imports the drug. (6) In subregulation (5), "evidence of alteration in the label" includes circumstances where- (a) the entire label or a part of the label with the details such as the batch number or the date of manufacture of the drug is removed; (b) there is evidence of removal of the original label and evidence of attaching another label or evidence of placing a label over the original label; or (c) there is evidence of erasing or concealing the original details of the label and replacing the details with other details.

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 “Packaging for imported drugs”.

“(1) The primary packaging of an imported drug shall be clearly labelled in English with the following- (a) the trade or brand name, where appropriate;”

Primary legislation Source quotation matched

Practical effect

Use this definition when interpreting other provisions that employ the language addressed by “Packaging for imported drugs”.

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

Elements or requirements

Operative requirements extracted from the consolidated text.

13

(1) The primary packaging of an imported drug shall be clearly labelled in English with the following- (a) the trade or brand name, where appropriate;
(b) the generic name of the drug;
(c) the quantities of active ingredients in the drug;
(d) the dates of manufacture and expiry of the drug;
(e) the batch or lot number of the drug;
(f) any special conditions of storage applicable to the drug;
(g) the name and address of the manufacturer of the drug;
(h) a unique identification feature, if any; and

5 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

No express internal or cross-Act reference appears in this section.

Amendment notes

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

8. Container closure system

The inner primary package of an imported drug shall be sealed in such a way that the drug is not accessible, got in contact with or tampered with without damaging the seal.

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 “Container closure system”.

“The inner primary package of an imported drug shall be sealed in such a way that the drug is not accessible, got in contact with or tampered with without damaging the seal.”

Primary legislation Source quotation matched

Practical effect

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

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

Elements or requirements

Operative requirements extracted from the consolidated text.

1

The inner primary package of an imported drug shall be sealed in such a way that the drug is not accessible, got in contact with or tampered with without damaging the seal.

Judicial interpretation

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

0

No judgment in the current Wakilii corpus expressly cites this section. Bare rule-number references are not assigned where the Order cannot be verified.

Related provisions

No express internal or cross-Act reference appears in this section.

Amendment notes

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

9. Verification of drugs by the Authority at port of entry

(1)

The imported drugs shall be accompanied by the certificate of analysis of the drug issued by the country of manufacture and the certificate of conformity or the test report, relating to the specific batch or lot imported. (2) The Authority shall, on the arrival of a consignment of drugs at a port of entry into Uganda, inspect the drugs to confirm that the drugs comply with the approved specifications and that each batch is accompanied by a certificate of analysis.

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 “Verification of drugs by the Authority at port of entry”.

“(1) The imported drugs shall be accompanied by the certificate of analysis of the drug issued by the country of manufacture and the certificate of conformity or the test report, relating to the specific batch or lot imported. (2) The Authority shall, on the arrival of a consignment of drugs at a port of entry into Uganda, inspect the drugs to confirm that the drugs comply with the approved specifications and that each batch is accompanied by a certificate of analysis.”

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 imported drugs shall be accompanied by the certificate of analysis of the drug issued by the country of manufacture and the certificate of conformity or the test report, relating to the specific batch or lot imported. (2) The Authority shall, on the arrival of a consignment of drugs at a port of entry into Uganda, inspect the drugs to confirm that the drugs comply with the approved specifications and that each batch is accompanied by a certificate of analysis.

Judicial interpretation

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

0

No judgment in the current Wakilii corpus expressly cites this section. Bare rule-number references are not assigned where the Order cannot be verified.

Related provisions

No express internal or cross-Act reference appears in this section.

Amendment notes

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

10. Re-export of imported drugs not allowed into Uganda

(1)

Where the Authority does not allow imported drugs into Uganda, the importer of the drugs shall re-export the drugs to the supplier, in the country of origin of the drugs, within a period of one month of the decision by the Authority to refuse entry into Uganda.

(2)

Subregulation (1) shall apply where the drugs are refused entry into Uganda for reasons other than the quality of the drug. (3) Where the Authority refuses to allow imported drugs, due to the poor quality of the drugs, the drugs shall be destroyed by the Authority at the cost of the importer.

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 “Re-export of imported drugs not allowed into Uganda”.

“(1) Where the Authority does not allow imported drugs into Uganda, the importer of the drugs shall re-export the drugs to the supplier, in the country of origin of the drugs, within a period of one month of the decision by the Authority to refuse entry into Uganda.”

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) Where the Authority does not allow imported drugs into Uganda, the importer of the drugs shall re-export the drugs to the supplier, in the country of origin of the drugs, within a period of one month of the decision by the Authority to refuse entry into Uganda.
(2) Subregulation (1) shall apply where the drugs are refused entry into Uganda for reasons other than the quality of the drug. (3) Where the Authority refuses to allow imported drugs, due to the poor quality of the drugs, the drugs shall be destroyed by the Authority at the cost of the importer.

Judicial interpretation

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

0

No judgment in the current Wakilii corpus expressly cites this section. Bare rule-number references are not assigned where the Order cannot be verified.

Related provisions

No express internal or cross-Act reference appears in this section.

Amendment notes

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

11. Procedure for re-export of drugs not allowed into Uganda

(1)

For the purposes of regulation 10, the person who re-exports drugs that are refused entry into Uganda, shall make an application for verification to the Authority and the application shall be accompanied by the relevant invoices and other documents related to the drugs including the exact point of destination of the drugs and the prescribed fees.

(2)

The Authority shall inspect the consignment to confirm the contents.

(3)

The Authority shall issue a re-export permit to the person to reexport the drugs.

(4)

The Authority shall witness the loading of the drugs for reexport.

(5)

The person who re-exports the drugs shall submit to the Authority a written document of re-export issued by the relevant authorities at a port of exit from Uganda, certifying that the drugs were re-exported.

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

Procedural rule

This section establishes the governing procedure for “Procedure for re-export of drugs not allowed into Uganda”.

“(1) For the purposes of regulation 10, the person who re-exports drugs that are refused entry into Uganda, shall make an application for verification to the Authority and the application shall be accompanied by the relevant invoices and other documents related to the drugs including the exact point of destination of the drugs and the prescribed fees.”

Primary legislation Source quotation matched

Practical effect

A litigant should address this rule at the procedural stage named in the section and preserve evidence of 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) For the purposes of regulation 10, the person who re-exports drugs that are refused entry into Uganda, shall make an application for verification to the Authority and the application shall be accompanied by the relevant invoices and other documents related to the drugs including the exact point of destination of the drugs and the prescribed fees.
(2) The Authority shall inspect the consignment to confirm the contents.
(3) The Authority shall issue a re-export permit to the person to reexport the drugs.
(4) The Authority shall witness the loading of the drugs for reexport.
(5) The person who re-exports the drugs shall submit to the Authority a written document of re-export issued by the relevant authorities at a port of exit from Uganda, certifying that the drugs were re-exported.

Judicial interpretation

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

0

No judgment in the current Wakilii corpus expressly cites this section. Bare rule-number references are not assigned where the Order cannot be verified.

Related provisions

No express internal or cross-Act reference appears in this section.

Amendment notes

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

12. Application of this Part

This Part shall apply to drugs which are imported for donation.

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 of this Part” applies.

“This Part shall apply to drugs which are imported for donation.”

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

This Part shall apply to drugs which are imported for donation.

Judicial interpretation

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

0

No judgment in the current Wakilii corpus expressly cites this section. Bare rule-number references are not assigned where the Order cannot be verified.

Related provisions

No express internal or cross-Act reference appears in this section.

Amendment notes

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

13. Conditions for importation of drugs for donation

(1)

The importation of a drug for donation shall only be allowed where the recipient of the drug or the donor of the drug informs the Authority of the necessity for the drug, which shall be directly related to the disease pattern of the recipient.

(2)

For the purposes of subregulation (1), the recipient of the drug or the donor, shall prior to the shipment of the drug, notify the Authority of the range and quantities of the drug to be imported, the population to be served and the particulars of the recipient of the drug.

(3)

The Authority shall in writing, authorise the importation of the drug for donation and shall specify the conditions of the donation.

(4)

The drug shall on arrival in Uganda, be verified 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 “Conditions for importation of drugs for donation”.

“(1) The importation of a drug for donation shall only be allowed where the recipient of the drug or the donor of the drug informs the Authority of the necessity for the drug, which shall be directly related to the disease pattern of the recipient.”

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) The importation of a drug for donation shall only be allowed where the recipient of the drug or the donor of the drug informs the Authority of the necessity for the drug, which shall be directly related to the disease pattern of the recipient.
(2) For the purposes of subregulation (1), the recipient of the drug or the donor, shall prior to the shipment of the drug, notify the Authority of the range and quantities of the drug to be imported, the population to be served and the particulars of the recipient of the drug.
(3) The Authority shall in writing, authorise the importation of the drug for donation and shall specify the conditions of the donation.
(4) The drug shall on arrival in Uganda, be verified 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.

14. Quality assurance and shelf life of donated drugs

(1)

The drug imported for the purposes of donation shall be obtained from a source approved by the Authority.

(2)

The quality of the drug imported for donation shall conform to the authorised pharmacopoeias and the presentation, strength and formulation of the drug shall as far as possible, be similar to the drug which is commonly used in Uganda. (3) The drug imported for the purposes of donation shall have a remaining shelf life of at least one year, calculated from the date the drug is allowed entry into Uganda, at a port of entry. (4) A vaccine and any other biological product imported for the purposes of donation shall have at least three quarters of its stated shelf life, remaining, at the time the vaccine or biological product is allowed entry into Uganda at the port of entry.

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 assurance and shelf life of donated drugs”.

“(1) The drug imported for the purposes of donation shall be obtained from a source approved by the Authority.”

Primary legislation Source quotation matched

Practical effect

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

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

Elements or requirements

Operative requirements extracted from the consolidated text.

2

(1) The drug imported for the purposes of donation shall be obtained from a source approved by the Authority.
(2) The quality of the drug imported for donation shall conform to the authorised pharmacopoeias and the presentation, strength and formulation of the drug shall as far as possible, be similar to the drug which is commonly used in Uganda. (3) The drug imported for the purposes of donation shall have a remaining shelf life of at least one year, calculated from the date the drug is allowed entry into Uganda, at a port of entry. (4) A vaccine and any other biological product imported for the purposes of donation shall have at least three quarters of its stated shelf life, remaining, at the time the vaccine or biological product is allowed entry into Uganda at the port of entry.

Judicial interpretation

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

0

No judgment in the current Wakilii corpus expressly cites this section. Bare rule-number references are not assigned where the Order cannot be verified.

Related provisions

No express internal or cross-Act reference appears in this section.

Amendment notes

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

15. Labelling and packaging

(1)

The drug imported for the purposes of donation shall be delivered in the original primary and secondary containers or packages of the drug. (2) For the avoidance of doubt, only a drug that is delivered in the original primary and secondary containers or packages and which has not been opened at the time the drug is allowed entry into Uganda, shall be allowed for the purposes of donation.

(3)

The label on a primary container or package of the drug imported for donation shall be in English and where the original label on the primary container or package of the drug is not in English, the primary container or package of the drug shall bear an English translation which shall be permanently fixed to the container but which shall not cover or erase the original label.

(4)

The label referred to in sub regulation (3) shall bear-

(a)

the name and address of the manufacturer of the drug;

(b)

the generic name of the drug (INN);

(c)

the date of manufacture of the drug and the batch or lot number of the drug;

(d)

the date of expiry of the drug;

(e)

the conditions under which the drug is to be stored; and

(f)

the dosage, form and strength of the drug.

(5)

The drug for donation shall be accompanied by the information of the prescriber of the drug, which shall be in English.

(6)

The drug imported for purposes of donation shall be packed in a strong tertiary container, and where there are more than one containers, the containers shall be sequentially numbered.

(7)

The drug shall be accompanied by a detailed packing list, which shall specify the contents of each container by the generic name of the drug and the batch number, expiry date and the quantity of the drug.

(8)

Where the drug imported for donation is imported alongside other items which are not drugs, the drug and the accompanying documents shall be packed separately from the other items.

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 “Labelling and packaging”.

“(1) The drug imported for the purposes of donation shall be delivered in the original primary and secondary containers or packages of the drug. (2) For the avoidance of doubt, only a drug that is delivered in the original primary and secondary containers or packages and which has not been opened at the time the drug is allowed entry into Uganda, shall be allowed for the purposes of donation.”

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.

13

(1) The drug imported for the purposes of donation shall be delivered in the original primary and secondary containers or packages of the drug. (2) For the avoidance of doubt, only a drug that is delivered in the original primary and secondary containers or packages and which has not been opened at the time the drug is allowed entry into Uganda, shall be allowed for the purposes of donation.
(3) The label on a primary container or package of the drug imported for donation shall be in English and where the original label on the primary container or package of the drug is not in English, the primary container or package of the drug shall bear an English translation which shall be permanently fixed to the container but which shall not cover or erase the original label.
(4) The label referred to in sub regulation (3) shall bear-
(a) the name and address of the manufacturer of the drug;
(b) the generic name of the drug (INN);
(c) the date of manufacture of the drug and the batch or lot number of the drug;
(d) the date of expiry of the drug;
(e) the conditions under which the drug is to be stored; and

5 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

No express internal or cross-Act reference appears in this section.

Amendment notes

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

16. Transport costs and other charges

The person who donates the drug and the recipient of the drug shall agree, prior to the importation, on the responsibility for the costs of-

(a)

the international and national transportation of the donated drug;

(b)

the customs warehousing and storage; and

(c)

the clearing and other ancillary activities.

Section analysis Source-linked statutory analysis Source linked

Approved statute annotation. Statutory quotations are matched to this consolidation and judicial passages are linked to judgments. Check the primary sources alongside this analysis.

What this section does

Mandatory duty

This section imposes mandatory requirements concerning “Transport costs and other charges”.

“The person who donates the drug and the recipient of the drug shall agree, prior to the importation, on the responsibility for the costs of-”

Primary legislation Source quotation matched

Practical effect

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

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

Elements or requirements

Operative requirements extracted from the consolidated text.

3

(a) the international and national transportation of the donated drug;
(b) the customs warehousing and storage; and
(c) the clearing and other ancillary activities.

Judicial interpretation

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

0

No judgment in the current Wakilii corpus expressly cites this section. Bare rule-number references are not assigned where the Order cannot be verified.

Related provisions

No express internal or cross-Act reference appears in this section.

Amendment notes

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

17. Certificate of donation

(1)

A donor shall provide to the recipient of the drug a certificate of donation, certified by an authorised person, who shall be a person with authority to sign such a certificate on behalf of the country of origin of the donor.

(2)

The certificate of donation shall indicate the conditions to be fulfilled by the recipient, if any, the name of the manufacturer of the drug, the name of the drug and its batch number, the dates of manufacture and expiry of the drug and any other condition as the authorised person may deem fit.

(3)

The recipients of drug for donation shall prior to the importation of the drug, furnish the Authority with the certificate of donation issued by the donor.

Section analysis Source-linked statutory analysis Source linked

Approved statute annotation. Statutory quotations are matched to this consolidation and judicial passages are linked to judgments. Check the primary sources alongside this analysis.

What this section does

Statutory power

This section confers or regulates the statutory power described as “Certificate of donation”.

“(1) A donor shall provide to the recipient of the drug a certificate of donation, certified by an authorised person, who shall be a person with authority to sign such a certificate on behalf of the country of origin of the donor.”

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) A donor shall provide to the recipient of the drug a certificate of donation, certified by an authorised person, who shall be a person with authority to sign such a certificate on behalf of the country of origin of the donor.
(2) The certificate of donation shall indicate the conditions to be fulfilled by the recipient, if any, the name of the manufacturer of the drug, the name of the drug and its batch number, the dates of manufacture and expiry of the drug and any other condition as the authorised person may deem fit.
(3) The recipients of drug for donation shall prior to the importation of the drug, furnish the Authority with the certificate of donation issued by the donor.

Judicial interpretation

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

0

No judgment in the current Wakilii corpus expressly cites this section. Bare rule-number references are not assigned where the Order cannot be verified.

Related provisions

No express internal or cross-Act reference appears in this section.

Amendment notes

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

18. Accountability for the use of donated drugs

(1)

A recipient of donated drug shall appoint a registered pharmacist, medical doctor, dentist or veterinary surgeon or where this is not practicable, appoint any other person to be responsible for the use of donated drug.

(2)

Where the person to be appointed to be responsible for the donated drug is not a registered pharmacist, medical doctor, dentist or veterinary surgeon, the appointment shall be approved by the Authority.

(3)

The recipient of donated drug shall make returns to the Authority showing how the drug is distributed and used.

(4)

Where the recipient of donated drug is not a health unit or the user of the drug, the user shall, through the recipient, make the returns required under subregulation (3).

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 “Accountability for the use of donated drugs”.

“(1) A recipient of donated drug shall appoint a registered pharmacist, medical doctor, dentist or veterinary surgeon or where this is not practicable, appoint any other person to be responsible for the use of donated drug.”

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) A recipient of donated drug shall appoint a registered pharmacist, medical doctor, dentist or veterinary surgeon or where this is not practicable, appoint any other person to be responsible for the use of donated drug.
(2) Where the person to be appointed to be responsible for the donated drug is not a registered pharmacist, medical doctor, dentist or veterinary surgeon, the appointment shall be approved by the Authority.
(3) The recipient of donated drug shall make returns to the Authority showing how the drug is distributed and used.
(4) Where the recipient of donated drug is not a health unit or the user of the drug, the user shall, through the recipient, make the returns required under subregulation (3).

Judicial interpretation

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

0

No judgment in the current Wakilii corpus expressly cites this section. Bare rule-number references are not assigned where the Order cannot be verified.

Related provisions

No express internal or cross-Act reference appears in this section.

Amendment notes

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

19. Prohibition of sale or transfer of

drugs imported for donation (1) A recipient of donated drug shall not sell donated drug.

(2)

A recipient shall not transfer the drug, without the written permission of 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 “Prohibition of sale or transfer of”.

“drugs imported for donation (1) A recipient of donated drug shall not sell donated drug.”

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

(2) A recipient shall not transfer the drug, without the written permission of 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.

20. Re-export of drugs imported for donation

(1)

Any drug imported for donation that does not comply with the requirements of this Part shall not be allowed entry into Uganda.

(2)

Where the Authority does not allow drugs imported for donation into Uganda, the importer of the drugs shall re-export the drugs to the supplier, in the country of origin of the drugs, within a period of one month of the decision by the Authority to refuse entry into Uganda.

(3)

Subregulation (2) shall apply where the drugs imported for donation are refused entry into Uganda for reasons other than the quality of the drug.

(4)

Where the Authority refuses to allow drugs for donation, due to the poor quality of the drugs, the drugs shall be destroyed by the Authority at the cost of the importer.

(5)

The Authority may order the destruction of drugs imported for donation which does not comply with the requirements of these Regulations at the cost of the donor and the recipient.

(6)

Where the drugs imported for donation are to be re-exported, regulation 11 shall apply.

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 “Re-export of drugs imported for donation”.

“(1) Any drug imported for donation that does not comply with the requirements of this Part shall not be allowed entry into Uganda.”

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.

6

(1) Any drug imported for donation that does not comply with the requirements of this Part shall not be allowed entry into Uganda.
(2) Where the Authority does not allow drugs imported for donation into Uganda, the importer of the drugs shall re-export the drugs to the supplier, in the country of origin of the drugs, within a period of one month of the decision by the Authority to refuse entry into Uganda.
(3) Subregulation (2) shall apply where the drugs imported for donation are refused entry into Uganda for reasons other than the quality of the drug.
(4) Where the Authority refuses to allow drugs for donation, due to the poor quality of the drugs, the drugs shall be destroyed by the Authority at the cost of the importer.
(5) The Authority may order the destruction of drugs imported for donation which does not comply with the requirements of these Regulations at the cost of the donor and the recipient.
(6) Where the drugs imported for donation are to be re-exported, regulation 11 shall apply.

Judicial interpretation

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

0

No judgment in the current Wakilii corpus expressly cites this section. Bare rule-number references are not assigned where the Order cannot be verified.

Related provisions

No express internal or cross-Act reference appears in this section.

Amendment notes

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

21. Exportation of drugs

(1)

A person shall not export drugs out of Uganda without a licence issued by the Authority. (2) An export licence shall be valid for one year and shall be in the format prescribed in Form 27 in the Schedule to these Regulations. (3) The Authority shall issue an export licence where it is satisfied that the applicant meets the criteria set out in this Part. (4) The Authority shall prior to issuing an export licence, ascertain that the facility from which the drugs to be exported, are manufactured, complies with internationally accepted Good Manufacturing Practice Guidelines adopted 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 “Exportation of drugs”.

“(1) A person shall not export drugs out of Uganda without a licence issued by the Authority. (2) An export licence shall be valid for one year and shall be in the format prescribed in Form 27 in the Schedule to these Regulations. (3) The Authority shall issue an export licence where it is satisfied that the applicant meets the criteria set out in this Part. (4) The Authority shall prior to issuing an export licence, ascertain that the facility from which the drugs to be exported, are manufactured, complies with…”

Primary legislation Source quotation matched

Practical effect

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

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

Elements or requirements

Operative requirements extracted from the consolidated text.

1

(1) A person shall not export drugs out of Uganda without a licence issued by the Authority. (2) An export licence shall be valid for one year and shall be in the format prescribed in Form 27 in the Schedule to these Regulations. (3) The Authority shall issue an export licence where it is satisfied that the applicant meets the criteria set out in this Part. (4) The Authority shall prior to issuing an export licence, ascertain that the facility from which the drugs to be exported, are manufactured, complies with internationally accepted Good Manufacturing Practice Guidelines adopted 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.

22. Application for an export licence

(1)

An application for a licence to export drugs shall be made using Form 28 in the Schedule to these Regulations and accompanied by the licence of the applicant to be a licensed person and the prescribed fees. (2) An application for a licence to export drugs shall be made by a licensed person.

(3)

A licence issued to a person to export drugs may be cancelled where the licence issued to that person to be licensed person under section 14 of the Act is cancelled 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

Scope rule

This section defines when and how “Application for an export licence” applies.

“(1) An application for a licence to export drugs shall be made using Form 28 in the Schedule to these Regulations and accompanied by the licence of the applicant to be a licensed person and the prescribed fees. (2) An application for a licence to export drugs shall be made by a licensed person.”

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) An application for a licence to export drugs shall be made using Form 28 in the Schedule to these Regulations and accompanied by the licence of the applicant to be a licensed person and the prescribed fees. (2) An application for a licence to export drugs shall be made by a licensed person.
(3) A licence issued to a person to export drugs may be cancelled where the licence issued to that person to be licensed person under section 14 of the Act is cancelled 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

Section 14 · Quality assurance and shelf life of donated drugs

Amendment notes

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

23. Verification of drugs by the Authority at port of exit

(1)

The exported drugs shall be accompanied by the certificate of registration, certificate of analysis and the certificate of conformity or the test report, relating to the specific batch or lot of drugs to be exported. (2) The Authority shall, on the arrival of a consignment of drugs at a port of exit out of Uganda, inspect the drugs to confirm that the drugs comply with the approved specifications and that each batch is accompanied by a certificate of analysis.

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 “Verification of drugs by the Authority at port of exit”.

“(1) The exported drugs shall be accompanied by the certificate of registration, certificate of analysis and the certificate of conformity or the test report, relating to the specific batch or lot of drugs to be exported. (2) The Authority shall, on the arrival of a consignment of drugs at a port of exit out of Uganda, inspect the drugs to confirm that the drugs comply with the approved specifications and that each batch is accompanied by a certificate of analysis.”

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 exported drugs shall be accompanied by the certificate of registration, certificate of analysis and the certificate of conformity or the test report, relating to the specific batch or lot of drugs to be exported. (2) The Authority shall, on the arrival of a consignment of drugs at a port of exit out of Uganda, inspect the drugs to confirm that the drugs comply with the approved specifications and that each batch is accompanied by a certificate of analysis.

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.

24. Container closure system

The inner primary package of a drug for export shall be sealed in such a way that the drug cannot be reached or tampered with, without damaging the seal.

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 “Container closure system”.

“The inner primary package of a drug for export shall be sealed in such a way that the drug cannot be reached or tampered with, without damaging the seal.”

Primary legislation Source quotation matched

Practical effect

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

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

Elements or requirements

Operative requirements extracted from the consolidated text.

1

The inner primary package of a drug for export shall be sealed in such a way that the drug cannot be reached or tampered with, without damaging the seal.

Judicial interpretation

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

0

No judgment in the current Wakilii corpus expressly cites this section. Bare rule-number references are not assigned where the Order cannot be verified.

Related provisions

No express internal or cross-Act reference appears in this section.

Amendment notes

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

25. Conditions of licences

A licence issued under the Act and these Regulations shall indicate the conditions under which the licence is issued and shall state that the licence 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 “Conditions of licences”.

“A licence issued under the Act and these Regulations shall indicate the conditions under which the licence is issued and shall state that the licence 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

A licence issued under the Act and these Regulations shall indicate the conditions under which the licence is issued and shall state that the licence 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.

26. Renewal of licence

(1)

A person who wishes to renew a licence issued under these Regulations shall make an application for renewal of the licence to the Authority.

(2)

An application for renewal of a licence shall be three months prior to the date of expiry of the licence.

(3)

The procedure for applying for a licence under these Regulations shall be used for renewing a licence.

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 issued under these Regulations shall make an application for renewal of the licence to 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) A person who wishes to renew a licence issued under these Regulations shall make an application for renewal of the licence to the Authority.
(2) An application for renewal of a licence shall be three months prior to the date of expiry of the licence.
(3) The procedure for applying for a licence under these Regulations shall be used for renewing a licence.

Judicial interpretation

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

0

No judgment in the current Wakilii corpus expressly cites this section. Bare rule-number references are not assigned where the Order cannot be verified.

Related provisions

No express internal or cross-Act reference appears in this section.

Amendment notes

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

27. Cancellation of licence

The Authority shall cancel a licence issued under these Regulations where the conditions of the licence 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 “Cancellation of licence”.

“The Authority shall cancel a licence issued under these Regulations where the conditions of the licence 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

The Authority shall cancel a licence issued under these Regulations where the conditions of the licence 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.

28. Approved ports of entry and exit

Drugs shall be imported or exported through ports of entry and exit approved and Gazetted 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 “Approved ports of entry and exit”.

“Drugs shall be imported or exported through ports of entry and exit approved and Gazetted 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

Drugs shall be imported or exported through ports of entry and exit approved and Gazetted 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.

29. Notification of change in ownership

Where the ownership of the licensed person who is granted a licence under these Regulations changes, the licensed person shall notify the Authority of the change and shall submit a certified copy of the documents indicating the change.

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”.

“Where the ownership of the licensed person who is granted a licence under these Regulations changes, the licensed person shall notify the Authority of the change and shall submit a certified copy of the documents indicating the change.”

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

Where the ownership of the licensed person who is granted a licence under these Regulations changes, the licensed person shall notify the Authority of the change and shall submit a certified copy of the documents indicating the change.

Judicial interpretation

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

0

No judgment in the current Wakilii corpus expressly cites this section. Bare rule-number references are not assigned where the Order cannot be verified.

Related provisions

No express internal or cross-Act reference appears in this section.

Amendment notes

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

30. Revocation of regulations 19 and 20 of S.I 206-1

Regulations 19 and 20 of the National Drug Policy and Authority Regulations, S.I. 206-1 are revoked.

SHEDULE

FORMS Regulation 3 (2) IMPORT LICENCE FOR DRUGS (Issued under sections 44 and 46 of the Act)

This is to certify that: the applicant named ............................................................................................. of address ............................................................................................................ TIN .................................. is authorized to import into Uganda, in accordance with sections 44 and 46 of the Act, the following classified drugs and raw materials. ………………………………………………………………………………… ………………………………………………………………………………… ………………………………………………………………………………… ………………………………………………………………………………… …………………………………………………………………………………

Conditions

Section analysis Source-linked statutory analysis Source linked

Approved statute annotation. Statutory quotations are matched to this consolidation and judicial passages are linked to judgments. Check the primary sources alongside this analysis.

What this section does

Statutory power

This section confers or regulates the statutory power described as “Revocation of regulations 19 and 20 of S.I 206-1”.

“Regulations 19 and 20 of the National Drug Policy and Authority Regulations, S.I. 206-1 are revoked.”

Primary legislation Source quotation matched

Practical effect

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

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

Elements or requirements

Operative requirements extracted from the consolidated text.

0

This section states a single governing proposition and does not enumerate separate elements.

Judicial interpretation

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

0

No judgment in the current Wakilii corpus expressly cites this section. Bare rule-number references are not assigned where the Order cannot be verified.

Related provisions

No express internal or cross-Act reference appears in this section.

Amendment notes

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

1. This licence does not allow the

importation of narcotic and psychotropic drugs

2. The importation shall be through authorised

Customs entry points

3. Each consignment to be imported shall be verified prior to importation, by

the Authority

4. This permit shall be displayed at the premises for which

it is issued Permit. No. ..../IMP/.......... Date dd/mm/yyy

Fee Paid Ushs …………………………………

This permit expires on ................................................ (dd/mm/yyyy)

..................................................................................... For the Authority

Regulations 4(1) APPLICATION FOR IMPORT LICENCE FOR DRUGS

I hereby apply for an importation licence for drugs

1. Name of pharmacist-in-charge of the business …………………………

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

2. Name of the business for which application is made ……………………

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

3. File No.…………………………………………………………………

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

4. P.O. Box Number: ……………….. Tel: …………………. Fax: ………

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

5. This is a retail pharmacy/wholesale pharmacy/manufacturer of

drugs/others (Specify)……………………………………………………

6. Licence Number ………………………………... (the operating licence

of the Authority)

7. I hereby apply for the issue

of an importation licence for (Delete what is not applicable) (a) Materials and ingredients for the production of drugs (b) Materials and ingredients for the production of veterinary drugs (c) Finished drugs for human use. (d) Finished drugs for veterinary use. I understand that a separate verification certificate has to be obtained for each order placed and that a consignment coming into Uganda shall be issued with an authorization certificate by the Authority, at the port of entry into Uganda.

I have read and understood the regulations relating to the importation of drugs and raw materials for the manufacture of drugs into Uganda.

Signed (pharmacist-in-charge of the business of the applicant) ……………………………………………… Date ………………………. _______________________________________________________________ For NDA Use only: APPLICATION APPROVED/REJECTED

If rejected state reasons ………………………………………………………… ………………………………………………………………………………… ………………………………………………………………………………… Licence Number………………… Issued on …………………….. (Date)

Signed…………………………………. For the Authority SEAL/STAMP

Regulation 5(2)

PERMIT FOR THE IMPORTATION OF NARCOTICS AND PSYCHOTROPIC DRUGS

Import licence No. ............................................................................................. I, being the person charged with the administration of the law relating to the dangerous drugs to which the International Convention on Narcotic and Psychotropic Drugs apply, hereby certify that I have authorised .............................................................................................................................. .............................................................................................................................. (hereinafter called the importer) to import the drugs specified in this permit, which I am satisfied are required: (1) *for legitimate purposes (in the case of raw opium or coca leaf), or (2) *solely for medicinal or scientific purposes (in the case of Indian hem or drugs to which Chapter III of the International Opium Convention 1925, apply) from ............................................................................................ ................................................................................................................... Specify the narcotic and psychotropic drugs and the quantities of the drugs authorised for importation ................................................................................... .............................................................................................................................. .............................................................................................................................. .............................................................................................................................. .............................................................................................................................. .............................................................................................................................. This authorisation is issued subject to the following:

1. The drugs shall be imported before

(dd/mm/yyyy)

2. This permit is not a licence

to be in possession of or to supply the drug imported.

3. This permit does not relieve the

importer from compliance with any custom regulations in force for the time being relating to the importation of goods into or transhipment of goods in Uganda or any Post Office regulation for the time being in force in Uganda.

4. This permit is valid only for

the import and may be revoked at any time and in that event shall be immediately surrendered.

5. The permit shall be produced for

inspection when required by any duly authorised person.

6. This permit, unless sooner revoked, shall

be endorsed by the custom officer and inspector of drugs at the time of importation, or, if the importation is not effected before the date specified in condition No. 1, shall immediately after the date be surrendered to the Authority.

7. The consignment shall be imported by registered parcel post

addressed to ..................................................................................... ................................................................................................................... ...................................................................................................................

.............................................. .................................................... STAMP AND DATE For the Authority _______________________________________________________________ ENDORSEMENT BY INSPECTOR OF DRUGS AND CUSTOMS OFFICER AT THE TIME OF IMPORTATION

I hereby certify that the person named in the permit has today imported the consignment specified in the permit * ...................................... under Customs entry No. .......................... dated ........................... or by registered parcel post or insured Box Post (Parcel No. .................................................... dated ...........................................).

.................................................. .................................................. Signature of Inspector of Drugs Signature of Customs Officer

Name: ........................................... Name: ............................................ Title: .............................................. Rank: ............................................. Date: ............................................. Date: .............................................

*If not all the drugs for which this authorisation was granted are not imported, the Inspector of Drugs or Customs Officer shall indicate the actual amount of drugs imported. Description of narcotic and psychotropic drugs Amount

Regulation 6(1)

VERIFICATION CERTIFICATE FOR THE IMPORTATION OF DRUGS

Name of person (company or partnership) ………... T.I.N ……………. Address………………………………………………………………………… Import licence No. ……………………………………......................................

Are the drugs registered by the Authority? YES/NO (Delete whichever is not applicable)

If "no" list the drugs that are not registered ……………………….………… …………………………………… ……………………………………… If "no", the applicant has to apply to the Authority for registration of the drugs prior to importation.

The drugs are for: prescription only, pharmacy sale only, class C drugs, raw materials. (delete those which do not apply).

This certificate authorizes the above named company /partnership to import the following drugs ………………………………………………................……... ...............…………………………….. through ...................... (indicate the approved entry point).

Name of supplier/exporter ……………………………………………………

Address …………………………………………………………………………

Date …………………………… Signature ………………………… (For the Authority)

On arrival of the drugs specified in this certificate, at the specified port of entry, the consignment shall be inspected by an Inspector of Drugs in order to verify the information in this certificate and to check the quality of the drugs before clearance by the Customs. This certificate and all the other relevant documents shall be presented to the Inspector of Drugs at the port of entry into Uganda.

Regulation 6(2)

APPLICATION FOR A VERIFICATION CERTIFICATE FOR THE IMPORTATION OF DRUGS

A. Details of the applicant (*delete as appropriate)

1. Name of company ………………………………………………

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

2. P.O Box ………………………………4. Tel

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

3. Physical address…………………………………………………

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

5. Fax:………………………………………………………………

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

6. Email:…………………….………………………………………

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

7. Import Licence No................... 9. TIN:………………………

B. Details of the drugs (Note: Standard means pharmacopoeial standard, e.g. BP, BPC, USP, Ph Eur, etc.) Manufac Country Proprietary Pack No. of turer of Generic name Strength Standard Reg. No Supplier Name size packs (name manufact and site) ure

Name of pharmacist in charge of the business ....................................................

Signature:……………………. Date:……………………….

Regulation 21(2)

EXPORT LICENCE FOR DRUGS (Issued under sections 44 and 45 of the Act)

This is to certify that the applicant named .......................................................... of address ............................................................................................................. TIN ...................................................................................................................... is authorized to export from Uganda, in accordance with sections 45 and 46 of the Act, the following classified drugs and raw materials. ………………………………………………………………………………… ………………………………………………………………………………… ………………………………………………………………………………… ………………………………………………………………………………… …………………………………………………………………………………

Conditions

1. This licence does not authorise the

exportation of narcotic and psychotropic drugs.

2. This licence is valid only for

exportation through authorised Customs exit points.

3. Each consignment to be exported shall,

prior to exportation be verified by the Authority.

4. This permit shall be displayed at the premises for which

it is issued Permit. No. 000/EXP/YEAR Date: dd/mm/yyyy

Fee Paid Ushs

This permit expires on .......................................... (dd/mm/yyyy).

………………………………………… For the Authority

Regulation 22 (1) APPLICATION FOR EXPORT LICENCE FOR DRUGS

I hereby apply for an export licence for drugs

1. Name of pharmacist-in-charge of the business

…………………………………………………………………………...

2. Name of the business for which application is made ……………………

………………………………………………………………………….

3. File No. …………………………………………………………………

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

4. P.O Box Number: ………………. Tel: ………………. Fax: …………

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

5. This is a retail pharmacy/wholesale pharmacy/manufacturer

of drugs _______________________________________________________________

For NDA Use only: APPLICATION APPROVED/REJECTED If rejected state reasons ………………………………………………………………………………… Licence Number………………………. Issued on ……………………. (Date)

Signed…………………………………. For the Authority SEAL/STAMP

6. Manufacturer of drugs /others (Specify)

…………………………………………………………………………

7. Licence Number ………………… (Operating licence of the Authority)

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

8. I hereby apply for an exportation

licence for (Delete what is not applicable) (a) Materials and ingredients for the production of human drugs (b) Materials and ingredients for the production of veterinary drugs (c) Finished drugs for human use. (d) Finished drugs for veterinary use. I have read and understood the regulations relating to the exportation of drugs. Signed (pharmacist-in-charge of the business) ………… Date …………

RUHAKANA RUGUNDA (DR.) Minister of Health.

About this Act

Full text of the Act

Part I

1. Title

2. Interpretation

Part II

3. Importation of drugs

4. Application for import licence

5. Authorisation for importation of narcotic drugs and

6. Verification certificate

7. Packaging for imported drugs

8. Container closure system

9. Verification of drugs by the Authority at port of entry

10. Re-export of imported drugs not allowed into Uganda

11. Procedure for re-export of drugs not allowed into Uganda

Part III

12. Application of this Part

13. Conditions for importation of drugs for donation

14. Quality assurance and shelf life of donated drugs

15. Labelling and packaging

16. Transport costs and other charges

17. Certificate of donation

18. Accountability for the use of donated drugs

19. Prohibition of sale or transfer of

20. Re-export of drugs imported for donation

Part IV

21. Exportation of drugs

22. Application for an export licence

23. Verification of drugs by the Authority at port of exit

24. Container closure system

Part V

25. Conditions of licences

26. Renewal of licence

27. Cancellation of licence

28. Approved ports of entry and exit

29. Notification of change in ownership

30. Revocation of regulations 19 and 20 of S.I 206-1

1. This licence does not allow the

2. The importation shall be through authorised

3. Each consignment to be imported shall be verified prior to importation, by

4. This permit shall be displayed at the premises for which

1. Name of pharmacist-in-charge of the business …………………………

2. Name of the business for which application is made ……………………

3. File No.…………………………………………………………………

4. P.O. Box Number: ……………….. Tel: …………………. Fax: ………

5. This is a retail pharmacy/wholesale pharmacy/manufacturer of

6. Licence Number ………………………………... (the operating licence

7. I hereby apply for the issue

1. The drugs shall be imported before

2. This permit is not a licence

3. This permit does not relieve the

4. This permit is valid only for

5. The permit shall be produced for

6. This permit, unless sooner revoked, shall

7. The consignment shall be imported by registered parcel post

1. Name of company ………………………………………………

2. P.O Box ………………………………4. Tel

3. Physical address…………………………………………………

5. Fax:………………………………………………………………

6. Email:…………………….………………………………………

7. Import Licence No................... 9. TIN:………………………

1. This licence does not authorise the

2. This licence is valid only for

3. Each consignment to be exported shall,

4. This permit shall be displayed at the premises for which

1. Name of pharmacist-in-charge of the business

2. Name of the business for which application is made ……………………

3. File No. …………………………………………………………………

4. P.O Box Number: ………………. Tel: ………………. Fax: …………

5. This is a retail pharmacy/wholesale pharmacy/manufacturer

6. Manufacturer of drugs /others (Specify)

7. Licence Number ………………… (Operating licence of the Authority)

8. I hereby apply for an exportation