This volume presents information on new national regulatory decisions, and on voluntary withdrawal of products by manufacturers on grounds of safety, that were reported to WHO up to December 2000.
Products are listed alphabetically within sections; International Nonproprietary Names (INNs) have been used whenever possible. Each product entry includes, where available, the Chemical Abstracts Service registry number (CAS number); synonyms including other generic names and chemical names; the effective date on which the regulation came into force; a summary of regulatory measures taken by governments; brief explanatory comments where necessary; and legal and bibliographical references.
While the information cannot be regarded as exhaustive, either in terms of products or regulatory measures, it covers regulatory actions taken by a total of 41 governments on 76 products. It should be noted, none the less, that decisions taken by a limited number of governments on a specific product may not be representative of the positions of other governments. Moreover, the fact that a given product is not listed as regulated by a country does not necessarily mean that it is permitted in that country; it may mean that the relevant regulatory decision has not been communicated to WHO or that the product has not been submitted for registration. The efficacy of products listed is not addressed, but is an aspect that may be crucial when a government is considering regulatory action.
Criteria for the inclusion of products in the Consolidated List (see next page) were developed in 1985 and revised in the light of the comments received from governments. However, governments' interpretation of the criterion "severely restricted", in particular, continues to vary widely, leading to considerable unevenness in reporting. When necessary, additional information and/or clarification has been requested from governments; products which clearly do not meet the criteria have been omitted after consultation with governments.
Information received from non-governmental organizations has, in each case, been verified with governments. The information provided also includes references to relevant legal or statutory documents that enable the user to ascertain the legal context and scope of the regulations. Such references cannot be given for most entries relating to specific pharmaceutical products since the relevant licences are often made or amended by an administrative decision which is not published. Brief explanatory comments also appear, where necessary, to clarify certain regulatory actions and put them into broader context.