Conceptual approval

Conduct a feasibility study. This should discover whether accomplishment of the objective is feasible and propose several strategies or conceptual solutions for consideration. If feasible, approval to proceed should be secured. 

Conceptually, this procedure for Community authorisations (also known as the centralised procedure) resembles a hybrid of the national procedure and the mutual recognition procedure, with the differences that first, the application is submitted to EMEA second, the dossier supporting the application undergoes a detailed assessment by the CHMP before approval in any Member State of the EU third, the applicant is provided with an opportunity to clarify any issues raised by any of the EU Member States fourth, the procedure naturally has an extended time frame but stUl with predetermined deadlines and finally, the applicant ends up with an approval or a refusal to market the product in all or any Member States of the EU. The centralised procedure is shown in Figure 17.2. 

Where an applicant wishes to market a product in more than one Member State, an identical dossier will be sent to all relevant Member States. If an authorisation has not been previously granted, one Member State will be appointed by the applicant to act as RMS who will prepare a draft assessment report with a draft SPC and a draft of the labelling and package leaflet. The CMSs will have the opportunity to review and approve the documents. Therefore, conceptually, the decentralised procedure resembles the centralised procedure without the involvement of CHMP, representing consultation between the Member States before even the first marketing authorisation is granted. 

The conceptual design of the facility (approved civil layout) should be available and be compared with the actual construction. Details should be summarized in a tabular form describing ... 

The purpose of the Development Period is to specify, design, build, test, install, and support the business operation to be automated or updated, and approved in the Conceptualization Period using a structured process. Part 11 must be taken into account during all of these activities. The development process involves the following steps ... 

The in vitro-in vivo correlation (IVIVC) is an extremely useful exercise at the preformulation level that determines how scale up and post approval changes or Biowaiver principles would be exploited. Conceptually, IVIVC describes a relationship between the in vitro dissolution/release versus the in vivo absorption. This relationship is an important item of research in the development of drug... 

Though MTR was not approved for construction until after Wigner had left Clinton Laboratories, the precepts that he laid down during the early conceptual design gave engineers who completed the design a sound foundation. The MTR operated at Idaho very successfully for 20 years. 

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