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.
