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

On 31 January 2020, the UK ceased to be an EU Member State and entered an implementation period during which it continues to be treated by the EU as a Member State for many purposes. As a third country, the UK can no longer participate in the EU’s political institutions, agencies, offices, bodies (except to the limited extent agreed), but it continues to be subject to EU law and must submit to the continuing jurisdiction of the Court of Justice of the EU in accordance with the transitional arrangements in Part 4 of the Withdrawal Agreement. For further reading, see: Brexit—Life Sciences and News Analysis: Brexit Bulletin—key updates, research tips and resources.

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