Overview

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

Freyr has experience assisting the generic medicinal product manufacturers in adhering to the requirements of submissions to Health Authorities (HAs) in EU by all procedures. Freyr supports in preparation of product development report.  Freyr also has hands on experience in handling post approval submissions and renewals for all types of formulations including solid oral, liquid oral and parenteral dosage forms.

 

Freyr Expertise

  • Legal representation as marketing authorization holder (MAH) for the medicinal products manufacturers, who do not have establishments in European Economic Area (EEA)
  • Regulatory consultation/strategic support during the development stage of the medicinal products
  • Support in selection of dissolution parameters/multimedia/for performance of dissolution for test product and Reference Medicinal Product (RMP)
  • Preparation of product development report (discriminatory nature of media)
  • Designing the specifications (Finished product/API/In-process/ Intermediates)
  • Advice in the selection of Regulatory submission procedure based on the MAH’s requirements
  • Pre-submission administrative activities
  • Advice for appointment/consultation of Qualified Person (QP) for quality and Qualified Person for Pharmacovigilance (QPPV) [If applicant Office is not in EEA and they don’t have their own QP and QPPV]
  • Advice for consultation of Batch Release Testing site and batch control site testing (If Applicant don’t have their own sites in EEA)
  • Regulatory assessment / gap analysis of source documents / already registered dossier for their Regulatory adequacy
  • Compilation, technical review, finalization, publishing and submission of marketing authorization application (MAA) to EU HAs
  • Prepare Regulatory strategy in the response to HA queries (RTQs)
  • Prepare response to HA queries (HAQs) with supporting documents/data with scientific rationale to avoid delay in approval
  • Evaluation of change controls and supporting documents
  • Preparation of variation submission strategy
  • Compilation and submissions of Variations and Renewals for MAA
  • Track of renewal submissions for MAA in EU
  • Follow-up with Regulatory agencies for the approval of the MAA