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PHARMACEUTICAL LIBRARY

Categoria: European Healthcare Legislation

Homeopatic drugs Legislation

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Homeopatic drugs   A homeopathic Drug is defined as any medicinal product prepared from substances known as homeopathic stocks in accordance with a homeopathic manufacturing procedure described by the European Pharmacopeia, and it can contain a series of principles.  A completed homeopathic drug can consist in a stock of a raw substance or in its […]

Clinical Trials in the Healthcare Legislation

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Clinical Trials   For experiments conducted on humans clinical trials are subdivided into four main phases: the first phase is called “first administration phase” also known as “Human pharmacology phase”; the second phase is called “brief term safety” also known as “Therapy scouting phase”; the third phase is called “bulk administration” also known as “Therapy […]

What is the Abridged procedure for Patents

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Abridged procedure   In directive 2001/83/EC and in Regulation (EC) No. 726/2004 are set out the conditions to forward an application for Marketing Authorization. Through pre-clinical and clinical trials, which for ethical reasons should be avoided on animals and human where possible,  researchers are able to create original medicinal products and to schedule a list […]

The EMA role in Europe

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Role of the EMA (ex EMEA)   The European Agency for the Evaluation of Medicinal Products (EMEA) was established by Council Regulation (EEC)Number 2309/93 22 of July 1993 and it has been in force until 1995. It had the task to coordinate the efforts of the research in all Member States assessing both human and […]

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