Expertise across all kinds of Regulatory Affairs in EU!
Shanghai Jinji Business Consulting Co., Ltd. was established in 2004 by Dr. HartmutSteinel. Jinji has several partners in Europe who can provide or search the MAs and Dossiers for us, as well as the product registration. Together with our Partners in Europe we provide our expertise across all kinds of activites and projects in the fields of development, approval and certification, as well as dossier management for pharmaceuticals. This includes CTD applications for final dosage forms (national, European and EMA), CEP applications at EDQM, as well as obtaining existing licenses and addition of a manufacturer.
Jinji will assess, update and manage your documentation submitted for approval.
Options
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a)National application
The pharmaceutical could apply for a national approval. The product can then only be sold in that particular EU country.This is by far the easiest option.
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b)Multiple Recognition (MRP)
Multiple Recognition means that EU countries may approve the decision made about a medicinal product by another EU country.
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Decentralisedc)Decentralised Procedure (DCP)
The Decentralised Procedure is for applicants who wish to market a product in a number of EU member states at the same time when the product has not previously received an authorization in any EU member state.One Member State acts as Reference Member State (RMS) and will assess the DCP application and provide the other Member States with Assessment Report ,Summary of Product Characteristics, Labeling, Package Leaflet.
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d) Centralized application at EMEA (European Medicines Agency)
An approval for a medicinal product intended for use in all EU countries may be obtained by applying to the EMEA in London.
You prefer to purchase an existing MA or Dossier? We are on-hand to guide you through the process of obtaining licenses and dossiers including due diligence.Shanghai Jinji’s policy is to accompany our partners through the whole process of achieving a Market authorization in Europe.