Overview

A medicinal product, which has the same qualitative and quantitative composition of ingredients, same pharmaceutical form as that of reference medicinal product (RMP) as per the Directive 2001/83/EC Article 10(2)(b) and exhibits bioequivalence with the RMP shall be considered as generic medicinal product. Market authorization holder (MAH) of generic medicinal product should follow the EU guideline Article 10(1) of Directive 2001/83/EC for the registration in European Economic Area (EEA).   

The key advantage for the MAH is that they are not required to perform and include non-clinical and clinical studies in market authorization application (MAA) as safety and efficacy of the product has already been proved by innovator in their application. Since the MAH of generic medicinal product is same as RMP, in composition and formulation, only documents / data to prove the quality should be included in MAA. Additionally, the MAH will also need to submit bioequivalence of product with RMP to Health Authority (HA).

MAA for generic medicinal products can be submitted to HAs of EU member states by any of the following procedures:

Freyr advises the manufacturers in deciding the best possible procedure through which submission must be made. Freyr has prior experience in handling submissions in line with Article 10(1) requirements to HAs in EU by all procedures (CP/NP/MRP/DCP). Freyr caters submission services to EU countries for all types of formulations including solid oral, liquid oral and parenteral dosage forms. 

 

Freyr Expertise

  • Legal representation as MAH for the medicinal product manufacturers, who do not have establishments in 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 RMP
  • Preparation of product development report (discriminatory nature of media)
  • Designing the specifications (Finished product / API / In-process / Intermediates)
  • Support selection of Regulatory submission procedure i.e. CP, NP, DCP and / or MRP based on the MAH's requirements
  • Pre-submission administrative activities, DCP Slot booking (if more than one country), National filing (if one country), Request the country to act as RMS (Liaise with RMS in case of DCP filing)
  • 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 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 to MAA
  • Track of renewal submissions for MAA in EU
  • Follow-up with Regulatory agencies for the approval of the MAA