The following Life Sciences guidance note provides comprehensive and up to date legal information covering:
As explained in the Practice Note: Marketing authorisations—regulatory procedures for approval of medicinal products, no medicinal product may be placed on the market without having first obtained an approval known as a marketing authorisation (MA). The MA sets out the medical conditions (known as indications), patient population and dosage for which the product is authorised as well as any conditions imposed on the marketing authorisation holder (MAH).
There are several different legal bases upon which an application for an MA can be made. This Practice Note explores the different types of MA application and their legal bases as well as some practical considerations such as the content and form of an application for an MA, the duration, validity, cessation and suspension of MAs.
The regulatory framework for the authorisation of medicinal products is established by:
Directive 2001/83/EC (consolidated version 28.01.2019), the Pharmaceutical Code, which is implemented in the UK by the Human Medicines Regulations 2012 (HMRs), SI 2012/1916
Regulation (EC) 726/2004 (consolidated version 30.03.2019), the EMA Regulation, which establishes the European medicines regulator, the European Medicines Agency (EMA) and lays down the centralised procedure for the authorisation of medicinal products
Directive 2004/27/EC, which reformed the MA procedures. Directive 2001/83/EC (consolidated version 28.01.2019) reflects the changes introduced by Directive 2004/27/EC
The European Commission and the EMA have published the
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