Marketing authorisation information dossier

An Investigational Medicinal Product Dossier (IMPD) is intended to be more comprehensive than an IB, in that it should contain summaries of available quality data in addition to the safety and efficacy information that constitutes the main part of the IB. In total, it should provide information on the chemistry, manufacture, control and stability ofthe medicinal product, together with the results of non-clinical and clinical studies. In order to avoid repetition, the IB can be cross-referenced for non-clinical and clinical results. Ideally, the IMPD should follow the same structure as that which will be used later for the marketing authorisation application. For products with existing marketing authorisations, the Summary of Product Characteristics may replace the IMPD to varying extents (see Chapter 6). 

The basic requirements for the contents of the dossier of information accompan)dng the application for a marketing authorisation are the same whether it is submitted nationally or centrally and were laid out in detail in Directive 715/318/EEC and its subsequent amendments. These requirements were included as Annex 1 of the codified Directive 2001/83/EC. 

An application for a marketing authorisation must be accompanied, among other items, by specified pharmaceutical, preclinical and clinical particulars and documents (the dossier ). Three important summary documents in the dossier are the SPC, a Package or Patient Information Leaflet (PIL), and the sales presentation of the product (label). The SPC has a formally prescribed structure (Box 17.1), and forms the basis for authorised chnical prescribing of the medicinal product concerned. 

Part I was a summary of the information presented in the whole dossier and included the application forms and administrative particulars on fees, various declarations and the t)rpe of application as well as particulars of the marketing authorisation (lA), proposed SPC (IBl), proposals for packaging, labels and package or patient information leaflets (IB2), and any SPCs already approved in the Member State(s) for the particular product (IB3). Also included were separate Expert Reports on chemical and pharmaceutical (ICl), pharmacotoxicological (preclinical) (IC2), and chnical documentations (IC3), as... 

Regulation 2377/90 contains the following four annexes in which the substances are listed after evaluation I. Substances for which final MRLs have been fixed II. Substances for which MRLs are not deemed necessary in order to protect public health III. Substances with provisional MRLs - if a dossier is incomplete, the manufacturer may be given a set time (up to five years) in which to provide the necessary information IV. Substances for which it is not possible, due to safety concerns, to set an MRL - the administration of substances listed in this annex is prohibited throughout the EU and the marketing authorisation for the medicines concerned has been withdrawn. 

The information about the therapeutic qualities of licensed medicines is part of the product dossier to obtain and keep a marketing authorisation. For pharmacy preparations information about therapeutic quality and about its monitoring can be part of the product file (see Sect. 33.8). 

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