Legislation regulatory authorities

The consumer movement, particularly the Consumers Health Fomm, also has considerable political influence. As a result of political pressure exerted by HIV/AIDS pressure groups and industry, the DRA was reviewed, new legislation introduced and new committees established to ensure that the regulatory authority responded more efficiently to public and political needs. Professional associations, especially the Pharmacy Guild of Australia, have traditionally played an active role in decisions related to pharmaceutical regulation. The Australian Pharmaceutical Advisory Council was established by the Australian Government to advise the Commonwealth Minister for Health on pharmaceutical policy. 

When applying legislation to atmospheric emissions, the regulatory authorities can either control emissions from individual points of release or combine all of the releases together as a combined release from a bubble around the manufacturing facility. 

Some regulatory authorities have foreseen the future impact of TM and set up appropriate guidelines. The European Union has legislation for traditional herbal products. Another example is the Therapeutic Goods Administration of Australia, which has set up a complementary medicine section that controls the regulatory practices for TM. 

Subsequently, following agreement on Common Technical Document (CTD) format for the dossier. Commission Directive 2003/63/EC of 25 June 2003, replaced Aimex 1 of Directive 2001/83/EC (detailing scientific and technical requirements) with a new Annex (detailing scientific and technical requirements in CTD terms). Provisions are made in the legislation for the omission of data in certain circumstances where information is already available to the regulatory authorities from other sources, for example. 

WHO. A legislative scheme for regulating medicinal products for adaptation by small national drug regulatory authorities with limited manpower and other resources. Geneva World Health Organization 1993. (WHO/PHARM/93.244 annex 3). 

European medical device requirements are defined in EU Directive 93/42/EEC published in 1994. National legislation and regulatory authorities such as the U.K. Medicines and Healthcare products Regulatory Authority (MHRA) enforce this directive. Four classes of device are defined, each of which requires a visible CE marking of conformity. CE marking of conformity means that the manufacturer is satisfied that the medical device conforms to relevant EU Directives and that it is fit for purpose. Technical documentation supporting conformity related to automated devices includes ... 

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