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Domande AIC con procedura nazionale

Preparation of MA applications via national procedure, MRP, DCP and CP

Before being marketed, all medicinal products should be authorised by a competent Authority assessing their quality, safety and efficacy, and releasing a marketing authorisation (MA) at the end of a dedicated procedure.

In the European Union, for human medicinal products, the MA can be obtained following different authorisation procedures: the reference regulations include Directive 2001/83/EC (adopted with Legislative Decree no. 219 of 24 April 2006) and Regulation (EC) no. 726/2004, as amended. The future MA holder shall submit an application based on a dossier including all information related to the product in electronic format e-CTD, Common Technical Document), organised according to the indications at European level.

The national procedure provides for that the MA is obtained in one Member State only, while European procedures allow the approval in more Member States. The European procedures provided for by the regulations are the following: centralised procedure (CP), mutual recognition procedure (MRP) and decentralised procedure (DCP).

The applicability and regulatory requirements vary depending on the procedure. It is essential to know such requirements in details, to define a suitable strategy and an appropriate authorisation path for the concerned drug.

The services offered by Di Renzo Regulatory Affairs in this field are related to the regulatory assistance for:

  • national procedures
  • European centralised procedure (CP),
  • European mutual recognition procedure (MRP)
  • European decentralised procedure (DCP).

Thanks to its international cooperation with several consultants in the countries of the European Union as well as extra-EU countries, Di Renzo Regulatory Affairs can also take care of Euroean procedures in other member States of the European Union.