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National Drug Policy and Authority (Control of Publication and Advertisement Relating to Drugs) Regulations

Statutory Instrument 33 of 2014 Current version · as at 28 March 2014
Enacted2014
Commenced28 March 2014
Last amended—
Point-in-time consolidation · as at 28 March 2014. This page may not reflect amendments made after that date. Confirm the current position against the latest Uganda Gazette before relying on it.

About this Act

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

Jurisdiction
Uganda
Type
Principal Legislation
Status
In force
Language
English

Full text of the Act

0 parts · 5 sections

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

Uganda

National Drug Policy and Authority (Control of Publication and Advertisement Relating to Drugs) Regulations

Commenced on 28 March 2014

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

6. Application for approval of publications and

advertisements for drugs.

The National Drug Policy and Authority (Control of Publication and Advertisement Relating to Drugs) Regulations, 2014. (Made under Sections 33 and 64 of the National Drug Policy and Authority Act, Cap 206) IN EXERCISE of the powers conferred upon the Minister responsible for health by sections 33 and 64 of the National Drug Policy and Authority Act and on the advice of the National Drug Authority, these Regulations are made this 24th day of March, 2014.

These Regulations may be cited as the National Drug Policy and Authority (Control of Publication and Advertisement Relating to Drugs)

In these Regulations, unless the context otherwise requires- "Act" means the National Drug Authority Act; "advertisement" means a notice, circular, label, wrapper and any other promotional material; "promotional material" means a written, pictorial or visual material or a verbal statement or reference used in an advertisement.

These Regulations apply to all activities and materials for publications related to drugs or advertisements for drugs including promotions, promotion materials and packaging materials.

A person shall not make any publication or advertisement for drugs without the approval of the Authority.

The material for publication or advertisement-

(a)

shall be reliable, accurate, truthful, informative, balanced, up- to-date, capable of substantiation and in good taste; and

(b)

shall not contain misleading or unverifiable statements or omissions which may induce medically unjustifiable drug use or which may give rise to undue risks.

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 approval of publications and” applies.

“advertisements for drugs.”
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. (a) shall be reliable, accurate, truthful, informative, balanced, up- to-date, capable of substantiation and in good taste; and
  2. (b) shall not contain misleading or unverifiable statements or omissions which may induce medically unjustifiable drug use or which may give rise to undue risks.
Judicial interpretation

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

0

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

Related provisions
National Drug Policy and Authority Act
Amendment notes

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

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

6. Application for approval of publications and advertisements

for drugs. (1) A person who seeks to make a publication or an advertisement for a drug shall make an application to the Authority, using Form 45 in the Schedule to these Regulations.

(2)

An application for publication or advertisement shall be made by-

(a)

the holder of the patent of the drug;

(b)

a licensed person;

(c)

the manufacturer of the drug; or

(d)

an agent authorised by the manufacturer or the holder of the patent of the drug.

(3)

The application shall be accompanied by-

(a)

a sample of the material for which approval for publication or advertisement is sought; and

(b)

the prescribed fees.

(4)

Where the language of the materials required under subregulation (3) is not English, the materials shall be presented with certified English translations.

(5)

Where the terms to be used in an advertisement, are not the recognised scientific terms, the terms shall be consistent with the approved scientific data sheet or other legally determined scientific basis, approved or adopted by the Authority. (6) Where the language to be used for publication or advertisement may in the opinion of the Authority cause fear or distress, the Authority shall not allow the material to be used. (7) Where an applicant wishes to amend an application or part of the application submitted to the Authority, the applicant shall pay the prescribed fees for the proposed amendment.

(1)

Upon receipt of an application for approval of a publication or an advertisement made under regulation 6, the Authority shall verify whether the application conforms to the requirements of these Regulations. (2) Where the Authority is not satisfied with the information provided in the application, the Authority shall direct the applicant to provide further information as may be necessary to complete the application. (3) Where the Authority does not accept an application, the Authority shall, in writing, inform the applicant of this and the reasons for the decision.

(4)

Where the Authority is satisfied with an application, the Authority shall approve the application and issue an authorisation to make a publication or an advertisement for a drug, as the case may be.

(5)

The Authority may issue an authrorisation with conditions.

(6)

The authorisation shall be issued using Form 46 in the Schedule.

(7)

A person who is issued with an authorisation to make a publication or an advertisement for a drug, shall not, where conditions are imposed by the Authority, deviate from the conditions.

(1)

An advertisement intended for the general public-

(a)

shall contain information that assists the general public to make rational decisions on the use of the drug;

(b)

where the advertisement provides information on health issues, shall not take undue advantage of the concern for health; or

(c)

shall not be for prescription drugs, narcotics or psychotropic drugs, or promote drugs for conditions specified in the Fifth Schedule of the Act.

(2)

An advertisement intended for pharmacists and other health professionals-

(a)

shall contain information that is reliable, accurate, truthful, informative, balanced, up-to-date and capable of substantiation;

(b)

shall where required, indicate the appropriate limitations to the use of the drug;

(c)

shall not have omissions which are likely to induce medically unjustifiable drug use or give rise to undue risks; and

(d)

shall not, through selection of testimonials or other evidence which is not representative of the products effectiveness, make exaggerated claims or claim that it possesses special properties or quality which cannot be established.

A person who contravenes a provision of these Regulations commits an offence and is on conviction liable to a penalty in the Act.

Regulation 6(1)

APPLICATION FOR PUBLICATION OR ADVERTISEMENT FOR A DRUG

1. PARTICULARS OF APPLICANT

(1)

Name of applicant ………………………………...………….. (2) Physical address/location…………………………………………. (3) Plot No………Street…………….City/town………..…..……… (4) Box No……..…Telephone no……………signature…….………. (5) Full name and title of signatory…………………………………

Section analysis Source-linked statutory analysis Source linked
Approved statute annotation. Statutory quotations are matched to this consolidation and judicial passages are linked to judgments. Check the primary sources alongside this analysis.
What this section does
Governing rule

This section states the governing statutory rule for “PARTICULARS OF APPLICANT”.

“(1) Name of applicant ………………………………...………….. (2) Physical address/location…………………………………………. (3) Plot No………Street…………….City/town………..…..……… (4) Box No……..…Telephone no……………signature…….………. (5) Full name and title of signatory…………………………………”
Primary legislation Source quotation matched
Practical effect

Use this section as the starting statutory rule for “PARTICULARS OF APPLICANT”, together with the linked provisions and current consolidation.

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

Operative requirements extracted from the consolidated text.

1
  1. (1) Name of applicant ………………………………...………….. (2) Physical address/location…………………………………………. (3) Plot No………Street…………….City/town………..…..……… (4) Box No……..…Telephone no……………signature…….………. (5) Full name and title of signatory…………………………………
Judicial interpretation

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

0

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

Related provisions

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

Amendment notes

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

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

2. DESCRIPTION OF PUBLICATION OR ADVERTISEMENT

(1)

Type of activity for which application is made (for example launch, advertisement, talk-show, exhibition)…………..…..……

(2)

Type of material to be used (for example, posters, literature, bags, calendars) (applicant to attach 2 samples of materials) ……………………………………………………………….…. (3) Drug name …………………………………….…………………. (4) Language of the publication or advert…………………….…..….. (5) Date of submission of application…………………………….… (6) Intended target group …………………………………………….

Section analysis Source-linked statutory analysis Source linked
Approved statute annotation. Statutory quotations are matched to this consolidation and judicial passages are linked to judgments. Check the primary sources alongside this analysis.
What this section does
Governing rule

This section states the governing statutory rule for “DESCRIPTION OF PUBLICATION OR ADVERTISEMENT”.

“(1) Type of activity for which application is made (for example launch, advertisement, talk-show, exhibition)…………..…..……”
Primary legislation Source quotation matched
Practical effect

Use this section as the starting statutory rule for “DESCRIPTION OF PUBLICATION OR ADVERTISEMENT”, together with the linked provisions and current consolidation.

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

Operative requirements extracted from the consolidated text.

2
  1. (1) Type of activity for which application is made (for example launch, advertisement, talk-show, exhibition)…………..…..……
  2. (2) Type of material to be used (for example, posters, literature, bags, calendars) (applicant to attach 2 samples of materials) ……………………………………………………………….…. (3) Drug name …………………………………….…………………. (4) Language of the publication or advert…………………….…..….. (5) Date of submission of application…………………………….… (6) Intended target group …………………………………………….
Judicial interpretation

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

0

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

Related provisions

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

Amendment notes

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

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

3. FOR OFFICIAL USE ONLY

(1)

Fees payable…………………………………………………….. (2) Receipt No………….…Date………….. NDA entry No………. (3) Application and samples received by (name)……………………..

Signature………………………………….Date………………….

Regulation 7 (6)

AUTHORISATION TO MAKE A PUBLICATION OR AN ADVERTISEMENT FOR A DRUG

This is to certify that …………………………………………………………. , is authorised to make a publication or an advertisement for the following drugs 1 ………………………………………………………………………….. 2 …………………………………………………………………………. 3 …………………………………………………………………………. 4 ………………………………………………………………………… 5 ………………………………………………………………………… 6 ………………………………………………………………………… 7 …………………………………………………………………………

This authorisation is issue with the following conditions - 1 ………………………………………………………………………… 2 ………………………………………………………………………… 3 ………………………………………………………………………… 4 ………………………………………………………………………… 5 ...………………………………………………………………………..

This authorization is valid from ……………………..to ……………………

………………………………………… For: NATIONAL DRUG AUTHORITY.

Date of issuance:…………………………………………………..

RUHAKANA RUGUNDA (DR.) Minister of Health.

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 “FOR OFFICIAL USE ONLY”.

“(1) Fees payable…………………………………………………….. (2) Receipt No………….…Date………….. NDA entry No………. (3) Application and samples received by (name)……………………..”
Primary legislation Source quotation matched
Practical effect

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

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

Operative requirements extracted from the consolidated text.

1
  1. (1) Fees payable…………………………………………………….. (2) Receipt No………….…Date………….. NDA entry No………. (3) Application and samples received by (name)……………………..
Judicial interpretation

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

0

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

Related provisions

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

Amendment notes

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

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

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