Centralised Procedure

 

Centralised Procedure - Overview

The Centralised Procedure (CP) is commonly used to obtain marketing authorization for medicinal products. A CP is valid for all the European Union (EU) member states. Ever since its induction in 1995, the CP has been compulsory for all medicinal products manufactured using biotechnological processes, orphan medicinal products, and human products containing a new active substance that was not authorized in the community before May 20, 2004 (date of entry into force of Regulation (EC), no. 726/2004), which are intended for the treatment of AIDS, cancer, neurogenerative disorder, or diabetes.

Centralised procedure (CP) is optional for:

  • Products containing new active substances not authorized in the community before May 20, 2004.
  • Products that constitute a significant therapeutic, scientific, or technical innovation.
  • Products that require a community authorization in the interest of patients’ or animal health.

Freyr has experience assisting generic medicinal product manufacturers through the Centralised Procedure (CP), while adhering to the requirements of submissions to Health Authorities (HAs) in the EU. Freyr supports the preparation of Product Development Reports. 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.

Centralised Procedure - Expertise

  • Legal representation as Marketing Authorization Holder (MAH) for the medicinal products manufacturers who do not have establishments in the 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 the applicant’s office is not in the EEA, and they do not have their own QP and QPPV].
  • Advice for consultation of batch release testing site and batch control site testing (if the applicants do not have their own sites in the 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 responses 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.
  • Tracking of renewal submissions for MAA in the EU.
  • Follow-up with Regulatory agencies for the approval of the MAA.
Centralised Procedure

Celebrating Customers Success

 

Medicinal Products

Regulatory Affairs

India

Thank you for the timely support over the weekend, which allowed us to resubmit quickly after being notified. This continuously demonstrates Freyr's commitment towards our company’s milestones.

Director - Global Regulatory Affairs – Operations

India-based, Global Top Generic Pharma Company

 

Medicinal Products

Publishing

UK

I am sure you have heard by now that we have received our first-ever approval from the FDA for our Brands division. This is a major milestone for us as well as for my team here in Reg Ops. I would be remiss if I didn’t point out that we would not have been able to do this without the help of your dedicated team. From the original filing, then the following year of responses, all helped get us to final approval.

Thank you Freyr team for a job well done!

Sr. Director, Head of Regulatory Operations

Ireland-based, Global Specialty Pharmaceutical Company

 

Medicinal Products

Regulatory Affairs

USA

Please relate to the team the excellent job they have done on the IND reactivation. Specifically, the high-quality module 3, written by Freyr. It was very comprehensive, very few revisions were required, and we had no questions from Health Canada or FDA. No CMC questions: that was a first for me. So very responsive to my many requests, which I am sure can be frustrating but always helpful while producing excellent work.

Thank you for always being available and responding quickly and comprehensively to all my requests.

What a great team you have, Freyr.

Lynne McGrath

Regulatory Consultant

 

Medicinal Products

Regulatory Affairs

USA

Congratulations!!! ​

Thanks for your great support for a successful ANDA filing, especially to the publishing team. Heartfully appreciate their last hours of hard work.

Assistant Manager​

US-based, Leading, Complex Generic Pharmaceutical Products Company​

 

Medicinal Products

Regulatory Affairs

USA

Thank you all for the great support!​

CEO

US-based, Leading Innovative Pharmaceuticals Company​

 

Medicinal Products

Regulatory Affairs

USA

The ANDA receipt has been received! Thank you very much for your hard work, patience, and support for our work over the last couple of months. We are delighted that we were able to meet the timeline and hit an important corporate goal of our young company. ​

Thank you again, and we look forward to working with your team on the next project!

Senior Director of Business and Product Development​

US-based, Leading Innovator Pharmaceuticals Company​