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…