• Sat. May 15th, 2021

European Healthcare Legislation

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Medicinal products for pediatric use – “Pediatrics”

In 2006 the European Union adopted the Regulation of medicinal products for pediatric use, commonly called “pediatrics” (EC) number 1901/2006/CE, such regulation governs the development and the authorization of medicinal…

Biological Medicinal Products – “Biologicals”

Biologicals   A biological medicinal product, or simply called “Biological”, is a term used for drugs which derive from biological sources rather than as a result of a chemical synthesis.…

Homeopatic drugs Legislation

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…

Clinical Trials in the Healthcare Legislation

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”;…

What is the Abridged procedure for Patents

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…

Orphan Medicinal Products (OMP) – Special benefits for the SPONSOR

Orphan medicinal products   When a pharmaceutical industry is desirous in developing a medicinal product under normal condition of marketing, because of the little number of patients affected by a…

The EMA role in Europe

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…

Guidance on International Non-proprietary Name (INN)

Guidance on International Non-proprietary Name (INN)   The International Non-proprietary Names (INN) has the aim to provide to health professionals a unique and easy to consult method to identify pharmaceutical…

Bogus galenic preparation

Bogus galenic preparation and condamnation for the pharmacyst   Narration of one case of fake drug selling, patent violation and receiving stolen goods A pharmacist was selling a medicinal product…

Patents and Trademarks

Patents and Trademarks   An invention is a new and original proposal to a technical problem with the purpose to be used in industrial processes. It can be a process…

Supplementary Protection Certificate – European Healthcare Legislation

Supplementary Protection Certificate (spc)   The supplementary Protection Certificate (SPC) consists in the extension of the duration of market exclusivity on a patented medicinal product. The extension of a patent…

What is the invention?

What is the invention?   An invention is a proposal of a solution to a technical problem in the past remained unsolved or solved with other means, moreover an invention…

European Phamaceutical Legislation History

Brief overview on pharmaceutical legislation history   The finality of European pharmaceutical legislation turns out in its main objectives which are, to ensure public healthcare, to protect the efficacy of…