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After accepting an application, a one-year temporary licence is granted under Regulation 8 in Form B. Before receiving a temporary (or regular) licence, the applicant must execute a bond on Forms D and E. For major ports, the surety amount is Rs.25000/; for other ports, Rs.10000/. Surety may also be given in the form of National Savings ...
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efficacy and safety criteria), and also the circumstances where a marketing authorisation already granted may be withdrawn, suspended or revoked.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.
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.
Power of attorney. A power of attorney (POA) or letter of attorney is a written authorization to represent or act on another's behalf in private affairs (which may be financial or regarding health and welfare), business, or some other legal matter.
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 ...
The Foreign Agents Registration Act (FARA) (22 U.S.C. § 611 et seq.) is a United States law that imposes public disclosure obligations on persons representing foreign interests.