Marketing Authorisation Approval

Phase II - studies that might be conducted to investigate environmental hazards and thus eventually lead to risk mitigation measures that could, in the most extreme circumstances, lead to the product being refused a licence, marketing authorisation, approval etc. 

The final legal instrument is a Decision. A decision focuses on an individual measure and is directly binding in its entirety on the specific individuals or entities to whom it is addressed. The Commission uses Decisions to issue marketing authorisations for approval of new drugs granted under a centralised procedure (see Chapter 6). Figure 1.2 summarises the relationship between various legal instruments used in Europe. 

It should be noted that all technical data submitted in support of marketing authorisations remain confidential between the applicant and the regulatory authorities. In situations where the manufacturer of a drug substance is a different commercial entity to the applicant seeking approval of a drug product incorporating... 

The Summary of Product Characteristics (SPC) for a medicinal product reflects the information in the marketing authorisation of the product. It is prepared by the manufacturer and is intended for health professionals. Updates are necessary to reflect any approved changes by the regulatory body in the marketing authorisation. 

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... 

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... 

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. 

In the European Union there have been several petitions to approve stevia and its products. In 2000, the EU Commission refused marketing authorisation for Stevia rebaudiana Bertoni plants and dried leaves as a novel food or novel food ingredient (Official Journal of the European Communities, 2000). In October 2003, the SCF rejected a request to re-examine the restrictions on the uses of extracts of stevia. Its comment, after throroughly examining the evidence, was that the committee has serious doubts about the safety of stevioside and does not consider it acceptable for use in food (European Parliament, 2003). 

The clinical trial protocols have to be approved beforehand as do the results of the study prior to final marketing authorisation. (See also Figure 3)... 

In particular, promotional claims about side effects must reflect available evidence or be capable of substantiation by clinical experience. Substantiation need not be provided, however, in relation to the validity of elements approved in the marketing authorisation. 

Any information, claims or comparisons in promotional materials must be clearly referenced and, including the corresponding section of data on file, must be provided without delay on request by a healthcare professional or a competent administrative executive of the health system. Documentation is not necessary for indications approved in the marketing authorisation. 

All information included in marketing material shall be supported by documentation that can be provided on request. There is, however, no need to provide such documentation concerning information that has been approved in connection with the issue of a marketing authorisation. 

Medicinal products, subject to a marketing authorisation, must not be promoted before the grant of such marketing authorisation. Any promotion going beyond the indications or pharmaceutical forms approved in the marketing authorisation is inadmissible. 

Advertising to healthcare professionals for a specific medicinal product can be started only after it has received marketing authorisation from Swissmedic. The statements made when advertising to healthcare professionals must concur with the currently valid version of the approved professional information. Printed advertising (advertisements, pamphlets, brochures, etc.) to healthcare professionals must be easily legible in respect of font size and layout. 

National marketing authorisations were intended to be phased out from 1 January 1998. It was foreseen that beyond that date, all marketing authorisations within the European Union would have been issued under the rules governing medicinal products in the European Community through the Centralised Procedure, or the so-called Mutual Recognition or Decentralised Procedure (see below). However, national approvals for marketing have continued well beyond 1 January 1998. 

All manufacturing processes should be consistent with information provided in the marketing authorisation application, as accepted by the authorities. Methods shall be updated in the light of scientific advances, and modifications must be submitted for approval. 

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