Abstract
ABSTRACT
In May 1991 the Government of the Federal Republic of Germany issued a regulation concerning the future prohibition of the use of halogenated hydrocarbons. This is the first such activity by one of the member states of the EC.
The prohibition will be applicable also for those medicinal products where a license has not been granted in the past and will not be granted before this ordinance comes into effect in August 1991. Within this decision making process on licensing or on extending licences under the provisions of the Drug Act, the Federal Health Office (BGA) may grant temporary exceptions to the prohibition of application. Exceptions, however, will be made only on the condition that the medicinal products concerned are used to treat serious health disorders and that the use of the substances is absolutely necessary for the administration of the medicinal product.
The Safety Working Party of the CPMP is currently preparing a statement concerning the use of halogenated hydrocarbons and their alternatives in medicinal products.
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