Legal classification

Hazardous substance is used here in accordance with the criteria of German chemicals legislation irrespective of the fact whether a legal classification or manufacturer s classification exists. 

By force of circumstances the manufacturers of mineral wools participated in the development of test methods to distinguish between hazardous and non-critical fibres as well as appropriate criteria for legal classification. A delay in the innovation process was caused by the discussion as to which criteria for the restriction of... 

As other recombinant proteins and monoclonal antibodies came under development, the CBER held primary responsibility for this review, with the CDER retaining responsibility for hormones such as insulin and HGH. However, in 2003 all therapeutic proteins were transferred from the CBER to the CDER. This reassignment of review responsibility did not impact the legal classification of these protein products, such that the Center for Drug Evaluation and Research assumed responsibility for the review and approval of biologies approved under Section 351 of the PHSA. 

Paracetamol is an example of a medicine where the pack size makes a big difference to its legal classification. Table 1.1 lists the various pack sizes available. 

Reclassification (e.g. an over-the-counter switch ) remains the responsibility of each national RA. The EU guideline on changing legal classification for the supply of medicinal products (The rules governing medicinal products in the European Community - Vol. IHb) sets out the standards that must be fulfilled in order to change the legal classification of a medicinal product. 

Changing the legal classification in the United Kingdom of a medicine for human use guidance booklet, MCA 2002. 

For approximately 2000 substances, legal classifications are listed in aimex I of Directive 67/548/EEC. 

Additionally, in some member states national classifications aside from the legal classification of annex I exist. These classifications are not obligatory for placing products on the market. 

There are several ways to classify drugs of abuse. The most relevant classification to forensic science is the legal classification whereby the federal and state codes classify drugs of abuse as controlled substances by schedule. For the purposes of this chapter ihe discussion of the application of GC to drugs of abuse is limited to controlled substances. For the application of GC to other drugs, the reader is referred to Chapter 14 on clinical applications of GC. 

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