Marketing authorisation product information

The name and the address of the company that is responsible for the medicinal product in Switzerland (holder of the Swissmedic marketing authorisation) this information must either be stated in the advertisement itself or be clearly seen in the professional medium where the advertisement appears. 

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). 

E reflect information in the marketing authorisations of medicinal products... 

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. 

The plan will eventually prescribe a likely filing date for a marketing authorisation application (MAA) (product hcence). This date is vital and when the plan becomes public information, any slippage in the date is likely to impact on the share price of the company. Accordingly, senior members of the company must be confident that the date can be met. There will always be pressure to bring the date forward but this has a cost in resources, and risks damaging credibility with investors if the accelerated timelines cannot be met. 

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... 

Where a clinical trial was proposed with a marketed product then the CTMP scheme could be used. This was a streamlined process based on the fact that there were no quality issues with a product that had already been granted a marketing authorisation. The applicant submitted a copy of the trial protocol, provided information on the investigators and, depending on whether or not the applicant was the MAH, information on the procedures for reporting adverse drug reactions. It was only possible to use this procedure for UK marketed products. It did not apply to unauthorised products manufactured specifically for trial or to products, which were licensed only in countries other than the United Kingdom. 

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... 

Information on the centralised procedure can be accessed from the EC website (see end of chapter). The EMEA is required to ensure that the opinion of CHMP is given within 210 days after the receipt of a valid application. When an application is submitted for a marketing authorisation in respect of medicinal products for human use which are of major interest from the point of view of public health and in particular from the viewpoint of therapeutic innovation, the applicant may request an accelerated assessment procedure. If the applicant duly substantiates the request and if the CHMP accepts... 

For mutual recognition applications. Article 29 of Directive 2001/83/EC provides that where a Member State considers that there are grounds for supposing that the marketing authorisation of the medicinal product concerned may present a risk to public health, it shall forthwith inform the applicant, the RMS, other CMSs, and the EMEA. The Member State must state its reasons in detail and indicate what action may be necessary to correct any defect in the application. 

For reagents, reagent products, reference and control materials, of information concerning common technological characteristics and/or analytes, as well as any important and subsequent modification, including suspension of marketing authorisation. 

If the decision is favourable, the drug is granted a marketing authorisation (for 5 years renewable), which allows it to be marketed for specified therapeutic uses. The authority must satisfy itself of the adequacy of the information to be provided to prescribers in a Summary of Product Characteristics (SPC) and also a Patient Information Leaflet (PIL). 

Medicinal products, indications, possible applications, dosages, pharmaceutical forms and packaging may be described as new only within 1 year of their marketing authorisation in Switzerland. From the information, it must be obvious to what the term new refers. 

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. 

The indication that comprehensive information can be found in the professional information for the medicinal product and, if necessary, listing the medium in which the marketing authorisation holder makes it available to professionals who are entitled to prescribe, dispense or administer the medicinal products in humans, in accordance with the respective specifications of the legislation on therapeutic products. 

In certain cases companies may wish to obtain more than one marketing authorisation for the same medicinal product, through either simultaneous or subsequent applications. A specific procedure has been agreed for this between the EMEA and the European Commission. Under this procedure, companies should inform both the EMEA and the Commission Services at the latest four months prior to submission of their intentions, in particular providing the Commission with an explanation of the underlying motives for the multiple application and their intentions regarding exploitation of any authorisations granted. 

The Contract Giver should provide the Contract Acceptor with all the information necessary to carry out the contracted operations correctly in accordance with the marketing authorisation and any other legal requirements. The Contract Giver should ensure that the Contract Acceptor is fully aware of any problems associated with the product or the work which might pose a hazard to his premises, equipment, personnel, other materials or other products. 

---