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close this bookNational Drug Policy - Nigeria (FMOH, WHO; 2005; 32 pages)
View the documentFOREWORD
View the documentACKNOWLEDGEMENTS
View the documentACRONYMS
View the document1.0 INTRODUCTION
View the document2.0 DEFINITION
View the document3.0 GOALS OF THE NATIONAL DRUG POLICY
View the document4.0 OBJECTIVES OF THE NATIONAL DRUG POICY
View the document5.0. TARGETS OF THE NATIONAL DRUG POLICY
close this folder6.0 STRATEGIES FOR IMPLEMENTING THE NATIONAL DRUG POLICY
View the document6.1 SELECTION OF DRUGS
View the document6.2 PROCUREMENT OF DRUGS
View the document6.3 DRUG REVOLVING FUND SCHEME
View the document6.4 PRICING POLICY
View the document6.5 DRUG STORAGE
View the document6.6 DRUG DISTRIBUTION
Open this folder and view contents6.7 RATIONAL DRUG USE
View the document6.8 DONATED DRUGS
View the document6.9 LOCAL DRUG PRODUCTION
View the document6.10 LEGISLATION
View the document6.11 INSPECTION OF DRUGS
View the document6.12 IMPORTATION AND EXPORTATION OF DRUGS
View the document6.13 REGISTRATION OF DRUGS
View the document6.14 PATENTS
View the document6.15 QUALITY ASSURANCE
Open this folder and view contents6.16 REGULATIONS FOR PRESCRIBING AND DISPENSING DRUGS
View the document6.17 PHARMACOVIGILANCE
View the document6.18 DRUG INFORMATION AND PROMOTION
View the document6.19 DRUG FINANCING AND AFFORDABILITY
Open this folder and view contents6.20 RESEARCH AND DEVELOPMENT
View the document6.21 HERBAL AND OTHER TRADITIONAL REMEDIES
View the document6.22 HUMAN RESOURCES DEVELOPMENT
View the document6.23 CONTROL OF VETERINARY DRUGS
View the document6.24 INTERNATIONAL COOPERATION
View the document6.25 MONITORING AND EVALUATION
 

6.10 LEGISLATION

Legislation is the instrument by which the implementation of a drug policy is given a legal basis by statutorily defining the various strategies for achieving the objectives of the policy. It also defines the qualifications, duties, privileges, and obligations of individuals, organisations, institutions, and other bodies concerned with the implementation of the various strategies of the policy, and provides for sanctions in the event of violations.

For the effective implementation of legislation, there is need to review and update the relevant laws regularly, in consultation with relevant stakeholders, in order to achieve the desired objectives. Some of the existing drug laws are in dire need of review and harmonisation.

Accordingly the following measures shall be taken:

i. Government shall strengthen legislation relating to:

• The essential drugs policy,

• Definition of drugs,

• Registration of drugs,

• Control of the supply, importation, exportation, production, manufacture, storage, distribution, and sale of drugs;

• Prescribing and dispensing of drugs;

• Quality control of drugs and pharmaceutical substances;

• Licensing of manufacturing, wholesale and retail premises and their inspections;

• Regulation of the labelling and promotion of medicines (including traditional medicines);

• Establishment of different control regimens for drugs and especially scheduling of controlled substances;

• Imposition of fees for services;

• Administration and control of drugs including the procedure for appealing against regulatory decisions;

• Licensing of qualified persons;

• Types of packaging materials of medicines and other pharmaceutical products;

• National Health Insurance as it relates to drug supply to patients

• Disposal of unwanted or expired drugs;

• Delineation of prescribing/dispensing functions;

• Clinical trials;

• Offences and sanctions;


ii. Government shall also enact appropriate legislation in respect of the following:

• generic prescription and substitution,

• removal of import taxes on pharmaceutical raw materials,;

• parallel importation in accordance with Trade-Related Intellectual Property Rights (TRIPS),

• compulsory licensing in accordance with Trade-Related Intellectual Property Rights (TRIPS),

• drug donations,

• Good Manufacturing Practice,

• traditional and herbal medicines (advertisement and sales), and

• use of antibiotics and hormones in agriculture and livestock products;


iii. Government shall provide the necessary material and financial resources to strengthen enforcement of the provisions of the laws and regulations.

iv. Government shall designate special courts for drug-related offences in each of the geo-political zones of Nigeria for the speedy trial of persons or corporate bodies apprehended for such offences.

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