National Procedure (NP)

Preface to National Procedure

The National Procedure( NP) is a nonsupervisory pathway used for acquiring Market Authorization( Mama) for a medicinal product in a chosen European Union( EU) member state.

Submission Conditions for National Procedure

Manufacturers are needed to submit a request Authorization operation( MAA) to the competent authority of the separate EU member state for the review and approval of the Mama.

Review and approval Timeline for National Procedure

Utmost of the Health Authorities( HAs) in the EU bear two hundred and ten( 210) days for the review and approval of MAA under the National Procedure( NP), which may vary slightly grounded on the member state.

National Phase for Translation Conditioning

Upon the approval of the Mama, the member state carries out a public phase to restate the product information into the original languages for better understanding by healthcare professionals and cases.

Collective Recognition Procedure( MRP) after National Procedure

Still, they can file the same MAA to the needed state, which will be appertained to as Concern Member State( CMS), If the MA holder would like to register the medicinal product in any other EU member countries. The member state who authorize the MAA shall be in consideration as the Reference Member State( RMS).

Templarpharma’s support for National Procedure

Templarpharma, with its vast Regulatory experience, assists manufacturers in dealing with Composition 10( 1) cessions to HAs in the EU. They extend end- to- end cessions support for all procedures, including the National Procedure( NP).

Appointing QP for Quality and Pharmacovigilance

Templarpharma supports manufacturers in appointing good Person( QP) for quality and QP for Pharmacovigilance( QPPV) in the separate member countries to validate quality and organize post-market surveillance. We ensures compliance with the rearmost regulations for successful product enrollment in the EU.

Templarpharma Expertise in National Procedure( NP)

  • Legal representation as a Marketing Authorization Holder( MAH) for the medicinal product manufacturers who don’t have establishments in the European Economic Area( EEA).
  • Regulatory discussion/ strategic support during the development stage of the medicinal products.
  • Assistance provided in selecting dissolution parameters and multimedia for performing dissolution testing on both the test product and the Reference Medicinal Product (RMP).
  • Preparation of Product Development Report( discriminative nature of media).
  • Designing specifications( finished product/ API/ in- process/ interceders).
  • Advice in the selection of Regulatory submission procedure grounded on the MAH’s conditions.
  • Pre-submission executive conditioning.
  • Advice for appointment/ discussion of good Person( QP) for quality and good Person for Pharmacovigilance( QPPV).( If aspirant’s office isn’t in EEA and they don’t have their own QP and QPPV).
  • Advice for discussion of batch release testing point and batch control point testing( if aspirants don’t have their own point in EEA).
  • Regulatory assessment/ gap- analysis of source documents formerly registered dossier for their Regulatory acceptability.
  • collecting, specialized reviewing, finishing, publishing, and submission of the MAA and National Procedure to the EU HAs.
  • experts assist in formulating a regulatory strategy to respond to Health Authority queries (HAQs) during the approval process. This includes guidance on the appropriate approach and supporting documentation required to address any concerns raised by the authorities.
  • Prepare response to HA queries( HAQs) with supporting documents data with scientific explanation to avoid detention in approval.
  • Evaluation of change controls and supporting documents.
  • Preparation of variation submission strategy.
  • compendium and cessions of variations and renewals to the MAA.
  • Tracking of renewal cessions for the MAA in the EU.
  • Follow- up with Regulatory agencies for the approval of the MAA along with National Procedure.