National Drug Policy and Authority Act

This section provides definitions for terms used in the Act such as “advertisement”, “approved institution”, “authorised person”, “drug” and “Minister”.

Lists the functions and objectives the national drug policy must pursue, including availability, regulation, research, training, compliance with international controls, and combating abuse.

Establishes a National Drug Authority as a body corporate, defines its membership, states appointment by the Minister, and fixes three-year terms for certain members.

The drug authority's common seal is determined by the authority and kept by the secretary; when affixed it must be authenticated by any two signatures of the chairperson, the secretary or another commission member authorised by the drug authority; the secretary or any person authorised may enter into or execute contracts without the seal where seal is not required; sealed instruments authenticated as prescribed are admissible in evidence unless contrary is proved.

The drug authority is charged with implementing the national drug policy and must perform a set of specified functions relating to regulation, approval, control, promotion, guidance, and related activities connected to drugs and pharmacies.

Establishes a National Drug Authority Commission and lists functions it shall perform, including exercising authority functions when the drug authority is not sitting, monitoring implementation of decisions, establishing and revising working procedure, and performing other functions as directed.

The drug authority must meet at least six times a year; the National Drug Authority Commission must establish the working procedure for the drug authority.

The commission must regularly assess and estimate national drug needs and must promote investigations to provide accurate estimates.

All drugs imported into Uganda must be labelled, known and prescribed by their International Nonproprietary Names (generic names), except where no such name has been allocated and no satisfactory nonproprietary alternative exists.

Designates drugs in Schedules 1–3 as classified drugs, drugs/articles in Schedule 4 as exempted, and states that any classified or non-exempt drug is a restricted drug.

No person shall mix, compound, prepare, supply or dispense any restricted drug unless they are a registered pharmacist, medical practitioner, dentist, veterinary surgeon or a licensed person; specified limited exceptions and authorised supplies exist, and nurses or other authorised persons may supply or dispense under Ministerial regulations. Records kept under this section must be open to inspection by an inspector of drugs.

Section Licensed persons Section If, on application made in the prescribed form by any person, the authority is satisfied— that the applicant is fit to carry on a business of mixing, compounding and preparing and supplying restricted drugs

The authority must be satisfied of specified conditions before a licence is issued; a licence is valid for the period stated in it, and the authority has the power to revoke the licence if the holder contravenes the Act or ceases to be fit to carry on the business.

No person must not carry on a business supplying restricted drugs from premises unless a general or limited certificate under this Act is issued or in force; and no person must not supply any drug by means of an automatic machine.

The authority may issue a general or limited certificate for premises suitable for supplying restricted drugs; certificate-holders must notify the authority of physical alterations (or certify no alteration annually before end of January); the authority may revoke the certificate if premises become unsuitable and must keep a register.

If someone entitled under the Act to supply or dispense class A or B drugs loses such a drug or related records, they must report the loss to the inspector of drugs within seven days and give particulars; contravening this section is an offence punishable by a fine up to one million shillings, imprisonment up to five years, or both.

Imports and sales of drugs are prohibited unless the drug appears on the national formulary; the drug authority may authorize imports and sales in emergencies.

The drug authority must receive proposals for the revised list from the committee on essential drugs.

The Minister, on the advice of the authority, may declare a drug to be a classified drug by statutory instrument.

A pharmacist or licensed person shall not supply a class A or class B Group I drug unless it is under a prescription reasonably believed by the supplier to be valid.

Suppliers must record the date supplied and their name and address on prescriptions; if a prescription is fully dispensed the supplier must retain it and keep it on the dispensing premises for two years, available for inspection.

A pharmacist or licensed pharmacy must not supply a class A or B drug to a person who is not reasonably believed by the supplier to be a person to whom the drug may properly be supplied.

No person must not supply a classified drug that does not conform to the prescription or order under which it is supplied.

Suppliers of class A, B or C Group II drugs must record specified particulars in a Classified Drugs Book and keep prescribed records; sellers must obtain and verify signed orders in some sales and retain records for two years; contravention is an offence with fines or imprisonment.

No person shall supply any classified or restricted drug unless the drug is in a container of the prescribed description and the container bears a label giving the prescribed particulars of its contents.

Section 26 was repealed by section 93 of Act 3 of 2016.

Specified persons (e.g. those in section 14, licensed sellers on registered premises, licensed wholesale dealers on licensed premises, lawful purchasers for the sale purpose, and persons supplied or dispensed drugs by qualified medical professionals or approved institutions) may possess classified drugs; possession otherwise is an offence punishable by a fine up to two million shillings or imprisonment up to five years or both.

The Minister may withdraw a person's authority to obtain or supply narcotics if that person is convicted under the Act and the Minister thinks they should not be allowed to obtain, possess or supply drugs; the withdrawal is by Gazette notice and may follow the authority's recommendation. If the person is a registered/licensed medical practitioner, dentist or qualified veterinary surgeon, the Minister may also direct by Gazette notice that they must not give prescriptions or orders under the Act.

Section 29 has been repealed by section 93 of Act 3 of 2016.

Any person must not sell or supply drugs, medical appliances or similar articles that are impure, adulterated, unwholesome, not of the quality demanded, not conforming to the authorised pharmacopoeia, or not conforming to the prescription.

The authority may require a person proposing to sell a proprietary drug at retail to furnish information about the drug, including composition and descriptive matter.

The authority may prohibit retail sale of a proprietary drug when, in its opinion, certain specified problems exist (for example unjustified claims, health dangers, composition discrepancies, or misleading descriptive matter).

No person shall publish descriptive matter about a drug that is calculated to lead to its use, subject to listed exceptions.

Persons running a pharmacy must send prescribed returns to the authority within 21 days of starting and annually in January, and must notify the authority within 21 days of any change to previously submitted particulars.

The drug authority may examine drugs on application and payment, must set up an approval system for drugs not on the essential list, must keep a register of specialities, may delete entries, and must notify applicants if an application is dismissed.

The drug authority must advise the Minister on measures to ensure drug quality; bodies responsible for importation and distribution must carry out those measures.

No person may supply restricted drugs by wholesale unless authorised by a licence; the authority may grant licences on application and payment if satisfied of specified eligibility and premises/staffing conditions, and may revoke licences for contraventions or unfitness.

Persons are prohibited from manufacturing (1) drugs or preparations not on the national formulary unless approved by the authority; (2) specialities unless approved by the authority; and (3) classified drugs unless manufacture is carried out or supervised by a pharmacist. An exception exempts manufacture of preparations listed in the Sixth Schedule if carried out or supervised by a medical practitioner.

The Minister may, by statutory instrument, make regulations further limiting who may manufacture drugs and the premises for manufacture; and no person shall manufacture narcotic drugs or psychotropic substances under international control except for medical, dental or veterinary use.

The authority may issue certificates authorizing persons to carry out clinical trials for specified drugs; no one may conduct a clinical trial on any drug unless they possess such a certificate issued under subsection (1).

The National Drug Authority must encourage research and take appropriate herbal and other medicines into production; and, where economically advantageous and in the interest of developing a national drug industry, the drug authority must encourage and develop national production of essential drugs.

If restricted or classified drugs are kept on premises they must be kept in accordance with the Seventh Schedule; where an act on the premises breaches an employment duty the employee is deemed to have committed an offence, otherwise the occupier is deemed to have committed an offence; wilfully removing or altering a drug label (or doing another act) may be treated as an offence under subsection (1).

The drug authority must promote rational use of drugs and, in consultation with relevant bodies, develop training, raise public awareness, and disseminate policy information; it may adopt methods and materials effective in other countries.

A person who contravenes this Act commits an offence and, where no punishment is provided, is liable to a fine (up to one million shillings) or imprisonment (up to one year); harsher maximum penalties apply for Class A drugs, certain narcotics under international control, and repeat offences. The court must order reasonable payment to owners when no case is proved for seized items; proceedings under section 35 require the consent of the Director of Public Prosecutions.

If a body corporate commits an act or omission that would be an offence if done by an individual, every director, secretary and manager of the body corporate is deemed to have committed the offence unless they prove lack of consent/connivance and that they exercised all due diligence; similarly, partners in a firm are deemed to have committed an offence committed by a partner unless they prove lack of consent/connivance and due diligence.

Lists types of evidence that may be relevant in proceedings under the Act, including licences, permits or certificates, documents stating results of an analysis carried out for the authority, offences involving restricted drugs in a container, and other offences where container contents are in issue.

Establishes a drugs bureau under the inspector of drugs with duties to keep registers and lists of drugs and toxic substances, to supply information to medical professionals in poisoning emergencies, to require persons to furnish information about drugs, and sets confidentiality for information furnished.

The Minister may, on the advice of the drug authority, by statutory instrument, make regulations generally for better carrying into effect the provisions of this Act.

The Minister may amend the First through Eighth Schedules to this Act by statutory order after consulting the authority.

The Minister may make regulations for controlling the transportation of any drug or class of drugs, on the advice of the drug authority.

Persons or bodies must not import drugs into Uganda without a licence from the drug authority.

No person or body may export any drug or preparation unless they have a licence from the drug authority; exporters of classified drugs must keep prescribed export records.

The authority may grant permits to import or export classified drugs when an application is in the prescribed form, the prescribed fee is paid, and the authority is satisfied the applicant is suitable.

Section 47 was repealed by section 93 of Act 3 of 2016.

Section 48 was repealed by section 93 of Act 3 of 2016.

section 49 repealed by section 93 of Act 3 of 2016

Inspections: inspectors or assistant inspectors of drugs may enter premises or vehicles in specified circumstances; senior police officers may also enter or detain and enter in suspected-offence situations.

Empowered inspectors and certain police officers may enter, inspect, require information and take away drugs or records; where a drug is taken away the inspecting officer must tender reasonable payment except in specified cases (including suspicion of unfitness or anticipated proceedings), with payment required if analysis shows fitness or if proceedings are not commenced within six months.

An inspecting officer exercising powers under the Act must, on demand, produce a duly authenticated document showing that they are entitled to exercise those powers.

No person must not obstruct an inspecting officer exercising powers under this Part and must comply with any requirement made by that officer in exercise of those powers.

The statute establishes a secretariat headed by a secretary appointed by the drug authority, assigns the secretariat responsibility for day-to-day operations, gives the secretary custody of the seal and responsibility for minutes and records, allows the drug authority to determine other officers, and exempts employees from personal liability for acts done in good faith.

The provision lists the sources that make up the drug authority's funds and requires the drug authority to have a bank account in an approved bank.

The drug authority must prepare and submit annual estimates within three months before each financial year; it may submit supplementary estimates before year-end; the Minister must notify the drug authority of the decision within one month; no expenditure may be made from the drug authority's funds unless approved by the Minister in the estimates or supplementary estimates.

The drug authority must prepare annual statements of account and keep proper books and records, subject to directions and requirements by the Minister responsible for finance.

The drug authority's accounts must be audited; the drug authority must submit statements within four months after year end; the Auditor General must audit and deliver reports within two months after receipt; auditors have access to financial records and information.