Marketing authorization application documentation

The basis for applications will follow the principles laid down in basic European level legislation for the pharmaceutical sector. This is more or less common regardless of the actual mechanism used to gain an approval. The basic requirements for pharmaceutical marketing authorization applications are laid down in Directive 65/65/EEC (as amended). There are no specific requirements for pharmaceutical development or process validation included in the text of that document. 

Readers may also be aware that under the auspices of the ICH a document is being developed on the organization of the Common Technical Document. It is intended that this will result in a common format (and, to at least some extent, content) of marketing authorization applications in the jurisdictions of those party to the ICH process (Japan, the EEA, and the United States). At the time of writing, a draft document had been circulated for comment. When adopted and implemented, this will result in a considerable amendment to the format and sequencing of information in a marketing authorization application. 

In the earliest development pharmaceutics guideline it was indicated that development pharmaceutics studies may be needed to support a marketing authorization application. Subsequent documents have made it clear that such data will be expected to form part of the application. 

If the herbal medicinal product contains a preparation, rather than merely the herbal substance itself, the comprehensive specification for the herbal substance must be followed by a description and validation of the manufacturing process for the herbal preparation. The information may be supplied either as part of the marketing authorization application or by using the European Active Substance Master File procedure. If the latter route is chosen, the documentation should be submitted in accordance with the Guideline on active substance master file procedure" (EMEA/CPMP/QWP/227/02 and EMEA/CVMP/134/02). 

MAA Marketing Authorization Application SAD Safety Assessment Document... 

As more than 95% of new medicines are worked out in the ICH regions the technical requirements for the safety, efficacy and quality of new medicines is determined at large by ICH technical guidelines. The application format for registration (marketing authorization) of new medicines in ICH and associated countries (such as Canada, Switzerland and Australia) has to follow The Common Technical Document (CTD) which provides harmonized structure and format for new product applications. This Common Technical Document is divided into four separate sections and 5 modules (see Fig. 1). The four sections address the application organization (M4 Organization), the Quality section (M4Q), the... 

To obtain a national marketing authorization, an application is submitted to the competent authority of the MS. The documentation is the same as required for the MRP and the technical assessment should be completed within 210 days. Since... 

The requirements for the content of the application dossier are stated in Directive 75/318/EEC as amended, i.e., the documents and data in support of the application for marketing authorization pursuant to Article 4 of Council Directive 65/65/EEC must be organized in a file in four parts, containing ... 

Dossier of the Medicine Particulars and documents supporting the application for a marketing authorization. 

This is the name of what we used to know simply as the data sheet, or colloquially as the package insert. The SPC is the document that must be submitted in draft by companies to the MHRA/Reference Member State/European Medicines Evaluation Agency upon application for a marketing authorisation and, once approved, must then be provided to prescribers or suppliers of medicines, either with the product or at the time of promotion or within the previous 15 months of promotion of the product, written or verbal. The SPC includes the prescribing information for the product and represents the product licence approval for the medicine (see Section 12.2.1.1). It is the definitive statement between the competent authority and the company and, more importantly, is becoming the common basis of communication between the... 

Organizations should ensure that they are aware of exactly which activities they capture electronically within their marketing and supply applications would fall within the scope of any relevant ERES regulations. Records transmitted by electronic means such as fax, or word-processed documents that are subsequently printed, authorized, and maintained as paper records, may not always fall within this category. Mechanisms should be put in place for prospectively assessing the ERES capability of any new applications that they are intending to commission for their use. 

It must be remembered that compliance is monitored by adherence to GLP, whereas the regulatory authority and the receiving authority of the dossier when submitted for the application of a marketing permit or similar document review the science. 

Application to market a generic medicinal product can be made in one MS even when the reference product is only authorized in a different MS. In this case, the MS in which the reference product is marketed can be asked to transfer a copy of all the relevant documents by the MS holding the generic application. There is a one-month deadline for this. 

The documents that must accompany the application form are as follows the applicant company s incorporation certificate a letter of authorization from the manufacturer evidence of marketing of existing products certificate of sale and good manufacturing practice (GMP) for imported products and product information and data supporting documentation, sufficient to establish safety, efficacy and quality. 

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