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

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

  • Marketing authorisations in the EU—content and form of the application and other practical considerations
  • Regulatory framework
  • Legislation
  • Guidelines
  • 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
  • More...

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

As explained in the Practice Note: Marketing authorisations in the EU—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 in the EU. This Practice Note explores the different types of marketing authorisation application (MAA) available in the EU 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 EU regulatory framework for the authorisation of medicinal products is established by:

  1. Directive 2001/83/EC (consolidated version 26.07.2019), the Pharmaceutical Code

  2. Regulation (EC) 726/2004 (consolidated version 30.03.2019), the EMA Regulation, which establishes the EU 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 26.07.2019) reflects the changes introduced by Directive 2004/27/EC

Guidelines

The European Commission and the EMA

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