To commercialize and take a drug to market, pharmaceutical companies are subject to stringent regulations that aim to protect the patients. This puts pressure on Sponsors to respect complex rules and regulate the entire “life cycle” of a drug – from development to authorization and post-market surveillance.During the last years, a lot of drug regulations came into effect in Italy and Europe about this sector and below, seQure Life Sciences proposes you an overview and a summary about these new regulations:
- Italian Legislative Decree 219/06: an Italian Legislation that codifies the subject by specifying rules concerning the marketing of medicinal products for human use, homeopathic and plant-based medicines, the authorization system, importation, as well as the guidelines of good manufacturing, labeling and leaflets, wholesale, advertising, pharmacovigilance and penalties for violating these rules.
- European Legislation 2001/83/EC: this legislaton refers to human drugs and what can be defined as a “drug”. It also specifies what steps to take for Marketing Authorization and the renewal of the drug on the market for use.
- EU Regulation NO. 520/2012: this Regulation refers to pharmacovigilance activities and stipulates operational details to be respected by marketing authorization holders, national competent authorities and the EMA. The EMA has released Good Pharmacovigilance Practices (GVP) guidelines to facilitate PhV activities.
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