Centralised Procedure, CP, MAA Submissions, Medicinal products

Freyr helps Generic medicinal product manufacturers in preparation of product development report and supports Centralised Procedure (CP) to obtain a marketing authorization (MA) for medicinal products for all European Union (EU) member states (RMS &CMS).
Centralised Procedure (CP) is commonly used to obtain a marketing authorization for medicinal products. CP is valid for all European Union (EU) member states. Ever since its induction in 1995, CP has been compulsory for all medicinal products,
  • manufactured using biotechnological processes
  • orphan medicinal products
  • human products containing new active substance which were not authorized in the community before 20 May 2004 (date of entry in to force of Regulation (EC) No 726/2004)
  • which are intended for the treatment of AIDS, Cancer, Neurogenerative disorder or Diabetes.
CP is optional for:
  • products containing new active substances not authorized in the community before May 20, 2004
  • products which constitute a significant therapeutic, scientific or technical innovation
  • products which a community authorization is in the interests of patients or animal health
Know more at Freyr Page - Centralised Procedure (CP)

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