Marketing authorisations—content and form of the application and other practical considerations
Marketing authorisations—content and form of the application and other practical considerations

The following Life Sciences guidance note provides comprehensive and up to date legal information covering:

  • Marketing authorisations—content and form of the application and other practical considerations
  • Regulatory framework
  • Impact of Brexit on marketing authorisation
  • Content of an application dossier for a marketing authorisation
  • Conditional marketing authorisations
  • Marketing authorisation under exceptional circumstances
  • Types of application for marketing authorisation (legal bases)
  • Full application—Article 8(3) of the Pharmaceutical Code
  • Generic, hybrid or similar biological applications—Article 10 of the Pharmaceutical Code
  • Well-established use application—Article 10a
  • more

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.

Regulatory framework

Legislation

The regulatory framework for the authorisation of medicinal products is established by:

  1. 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

  2. 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

  3. 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

Guidelines

The European Commission and the EMA have published the