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This process is performed within a legal framework defining the requirements necessary for successful application to the regulatory authority, details on the assessment procedure (based on quality, efficacy and safety criteria), and also the circumstances where a marketing authorisation already granted may be withdrawn, suspended or revoked. [1]
A centralised marketing authorisation, issued by the European Commission, allows the holder to market a medicinal product throughout the European Economic Area (EEA), which comprises the EU Member States, Iceland, Norway and Liechtenstein. [2] In the United States, the equivalent process is called New Drug Application.
Regulation concerning the Registration, Evaluation, Authorisation and Restriction of Chemicals (REACH), establishing a European Chemicals Agency (ECHA) Made by: European Parliament and Council: Made under: Art. 95 (EC) Journal reference: L396, 30.12.2006, pp. 1–849: History; Date made: 18 December 2006: Entry into force: 1 June 2007 ...
In April 2019, U.S. Secretary of Transportation, Elaine L. Chao, who boarded a MAX flight on March 12 amid calls to ground the aircraft [22] created the Special Committee to Review the FAA's Aircraft Certification Process to review of Organization Designation Authorization, which granted Boeing authority to review systems on behalf of the FAA ...
The law of agency is an area of commercial law dealing with a set of contractual, quasi-contractual and non-contractual fiduciary relationships that involve a person, called the agent, who is authorized to act on behalf of another (called the principal) to create legal relations with a third party. [1]
The authorisation procedure is complex and concerns manufacturers, importers, downstream users and Only Representatives of substances [8] for which: No alternative to the Annex XIV substance is deemed technically and/or economically feasible or for which; Alternatives may exist but still need time to be fully qualified and deployed.
Only in 1917, shortly after the U.S. entered World War I, did Congress make the first formal attempts to regulate or restrict foreign lobbying, taking into consideration measures that would require foreign agents to publicly disclose their advocacy and prohibiting noncitizen residents from acting as foreign agents without prior government ...
The Electronic System for Travel Authorization (ESTA) is an automated system that determines the eligibility of visitors to travel to the United States under the Visa Waiver Program (VWP). ESTA was mandated by the Implementing Recommendations of the 9/11 Commission Act of 2007 . [ 1 ]