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procedure autorizzative per medicinali ad uso umano

Dossiers and authorisation procedures for human medicines

Regulation (EC) 726/2004 and Directive 2001/83/EC, as amended, provide for that medicinal products can be marketed in the EC only following the release of a marketing authorisation (MA) by a EU Member State or by the European Medicines Agency (EMA). To this end, it is required to prepare an appropriate authorisation dossier (in line with the community and national regulations in force) to be submitted to the Competent Authority and apply for the MA using the authorisation procedure that is more suitable for the business strategies.

The main services offered in this field are:

  • Due diligence and gap analysis
  • CMC Regulatory assistance
  • Drafting of chemical, clinical and pharmaco-toxicological expertise
  • Preparation of MA applications via national procedure, MRP, DCP and CP
  • Preparation of dossiers in CTD and eCTD
  • Preparation of MA variations, extensions, transfers and renewals
  • Support for the upload of procedures on the AIFA Front End
  • Support in the management of drug shortage in the new AIFA shortage portal (FEC)
  • Assistance for the submission of procedures via CESP
  • Support in the Sunset Clause management
  • Assistance for the environmental risk assessment (ERA)
  • Assistance for the Scientific Advice
  • Advice on OTC/Rx Switch
  • Regulatory advice on parallel importations and on importation to supply drug shortage
  • Regulatory advice on homeopathic products, medical gases, radiodrugs and allergens, orphan drugs
  • Assistance in the procedures regarding narcotics and drug precursors
  • Regulatory advice on borderline products
  • Regulatory advice for advanced therapies

Foto di stevepb