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Information Products on Pharmaceuticals - Renouf Publishing Co. Ltd.

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oms-catalogue 15/07/03 11:34 Page 25<br />

LEGISLATION AND REGULATION<br />

Internati<strong>on</strong>al Travel<br />

and Health 2003<br />

Situati<strong>on</strong> as <strong>on</strong> 1 January 2003<br />

Effective Drug Regulati<strong>on</strong><br />

A Multicountry Study<br />

Guidelines for the<br />

Regulatory Assessment<br />

of Medicinal <str<strong>on</strong>g>Products</str<strong>on</strong>g><br />

for Use in Self-medicati<strong>on</strong><br />

This editi<strong>on</strong> of Internati<strong>on</strong>al<br />

travel and health was completely<br />

redesigned in 2002 to reflect better<br />

knowledge about the risks to<br />

which travellers are exposed and<br />

the precauti<strong>on</strong>s needed to protect<br />

their health.<br />

The book offers guidance <strong>on</strong> the<br />

full range of health risks likely to<br />

be encountered at specific destinati<strong>on</strong>s<br />

and associated with different<br />

types of travel - from business,<br />

humanitarian and leisure travel to<br />

backpacking and adventure tours.<br />

<str<strong>on</strong>g>Informati<strong>on</strong></str<strong>on</strong>g> is intended to help the<br />

medical professi<strong>on</strong> be fully alert to<br />

potential risks and provide appropriate<br />

advice, whether c<strong>on</strong>cerning<br />

recommended vaccinati<strong>on</strong>s, protecti<strong>on</strong><br />

against insects and other disease<br />

vectors, or safety in different<br />

envir<strong>on</strong>mental settings. <str<strong>on</strong>g>Informati<strong>on</strong></str<strong>on</strong>g><br />

<strong>on</strong> infectious diseases of potential<br />

risk for travellers has also been<br />

greatly expanded. Additi<strong>on</strong>al chapters<br />

describe vaccine-preventable<br />

diseases, vaccines for routine and<br />

selective use, and selecti<strong>on</strong> criteria,<br />

and offer detailed guidance<br />

<strong>on</strong> malaria, the most important<br />

infectious disease threat for<br />

travellers.<br />

Drugs play a crucial role in saving<br />

lives, restoring health, and preventing<br />

diseases and epidemics. But<br />

they need to be safe, efficacious,<br />

of good quality, and used rati<strong>on</strong>ally.<br />

This means that their producti<strong>on</strong>,<br />

import/export, storage, supply and<br />

distributi<strong>on</strong> should be subject to<br />

government c<strong>on</strong>trol through prescribed<br />

norms and standards and<br />

an effective regulatory system.<br />

Substandard and counterfeit drugs<br />

proliferate primarily in an envir<strong>on</strong>ment<br />

where drug regulati<strong>on</strong> has<br />

proved ineffective.<br />

This publicati<strong>on</strong> presents a<br />

synthesis of studies <strong>on</strong> drug<br />

regulati<strong>on</strong> carried out in 10<br />

countries: Australia, Cuba, Cyprus,<br />

Est<strong>on</strong>ia, Malaysia, the Netherlands,<br />

Tunisia, Uganda, Venezuela, and<br />

Zimbabwe in 1998-1999. It gives<br />

an overview of the development of<br />

drug regulati<strong>on</strong> in these countries<br />

as well as the resources available<br />

and the strategies applied in drug<br />

regulati<strong>on</strong> implementati<strong>on</strong> at the<br />

time the studies were c<strong>on</strong>ducted.<br />

An analysis of the strengths and<br />

weaknesses in drug regulati<strong>on</strong> in<br />

these countries is also provided.<br />

Presents guidelines for determining<br />

when medicinal products, sold <strong>on</strong><br />

prescripti<strong>on</strong> <strong>on</strong>ly, can be reclassified<br />

for n<strong>on</strong>-prescripti<strong>on</strong>, or over-thecounter,<br />

sale. Noting that self-medicati<strong>on</strong><br />

plays an important role in<br />

the health care system, the booklet<br />

sets out criteria and methods<br />

intended to help drug regulatory<br />

authorities decide when a product<br />

is suitably safe and effective for<br />

self-medicati<strong>on</strong>.<br />

25<br />

2002, vii + 85 pages [E, F]<br />

ISBN 92 4 158028 3<br />

Swiss francs 25.–/US $22.50<br />

In developing countries: Sw.fr. 17.50<br />

Order no. 1180003<br />

by S. Ratanawijitrasin and<br />

E. W<strong>on</strong>demagegnehu<br />

2002, ix + 189 pages [E]<br />

ISBN 92 4 156206 4<br />

Swiss francs 20.–/US $18.00<br />

In developing countries: Sw.fr. 14.–<br />

Order no. 1150503<br />

2000, 31 pages [E]<br />

WHO/EDM/QSM/00.1<br />

Swiss francs 10.–/US $9.00<br />

In developing countries: Sw.fr. 7.–<br />

Order no. 1930175

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