Product characteristics document

Product Characteristics Commercial butane Commercial propane LPG motor fuel (from NF EN 589) (see AFNOR document M 40-003)... 

The packaging material should normally be selected so as to allow the optimal sterilization process to be applied to the product as a whole. Lfowever, factors other than the method of sterilization have to be taken into account in selecting a container material, such as the route of administration and patient convenience and compliance. Where the choice of container-closure precludes the use of terminal processing in the final container, the application should include appropriate documentation to explain and scientifically justify such a choice. The guidelines indicate that in such cases it is still the manufacturer s duty to continue the search for alternative containers that would allow terminal processes while providing the necessary product characteristics. 

The equivalence of high and low doses of antidepressants is well known, yet doctors often increase the dose of the antidepressant when their patients do not improve. Why do they do this The official Summary of Product Characteristics for Prozac provides a clue. It notes that in the fixed dose studies of patients with major depression there is a flat dose response curve, providing no suggestion of advantage in terms of efficacy for using higher than the recommended doses . Nevertheless, despite the absence of evidence that higher doses produce better effects, the very same document advises physicians as follows ... 

Much later. Directive 83/570 required the applicants to produce a draft Summary of Product Characteristics (SPC) as an integral part of the documentation. In September 1995, an order was made (SI 1995/2321) to the effect that, in the United Kingdom, data sheets were no longer required where a product had an approved SPC and also that data sheets no longer had to be sent to all doctors and dentists prior to advertising. 

Qualification protocol A prospective experimental plan stating how qualification will be conducted, (including test parameters, product characteristics, production equipment, etc.) and decision points on what constitutes an acceptable test. When executed, a protocol is expected to produce documented evidence that a system or subsystem performs as required. 

A] document which lays down product characteristics or their related processes and production methods, including applicable administrative provisions, with which compliance is mandatory [emphasis added]. It may also include or deal exclusively with terminology, symbols, packaging, marking, or labelling requirements as they apply to a product, process or production method. 

This relatively large document, which covers both human and veterinary medicines, is published as a special issue of Pharmeuropa. The first version was published in November 1996, then revised yearly the-next revised version was published in February 2000. This will produce a harmonious and coherent whole that can be used throughout Europe. The terms are mandatory for applications and summaries of product characteristics for EU centrally and decentrally authorizedproducts. 

The use of summaries of congress communications (abstracts) in an advertising document is acceptable when these comply with the summary of product characteristics and existing recent standards (less than 12 months old), and exist in a referenced journal. 

Non-promotional information for patients and the general public Subject to any applicable national laws and regulations, websites may include non-promotional information for patients and the general public on products distributed by the company (including information on their indications, side effects, interactions with other medicines, proper use, reports of clinical research, etc.), provided that such information is balanced, accurate and consistent with the approved summary of product characteristics (SPC). For each product that is discussed, the website must contain full, unedited copies of the current SPC and patient leaflet. These documents should be posted in conjunction with other information about the products or be connected with that discussion by a prominent link advising the reader to consult them. In addition, the website may provide a link to the full, unedited copy of any public assessment report issued by the Committee for Medicinal Products for Human Use or a relevant national competent authority. Brand names should be accompanied by recommended international non-proprietary names (rINNs). 

Applications must be in the national language (Bahasa Malaysia). All other data and supporting documentation, labels, Pis and summary of product characteristics (SPC) must be in Bahasa Malaysia or English. 

Glaxo Group Ltd. Summary of product characteristics Tyverb (lapatinib). http //www.ema. europa.eu/docs / en GB / document library/ EPAR - Product Information/human/... 

Summary of Product Characteristics for Pulmozyme. Available at http //www.produktresume. dk/docushare/dsweb/Get/Document-14730/Pulmozyme%2CJ)inhalationsv%C3%83%C2% A6skeJ)tilJ)nebulisator%2CJ)opl%C3%83%C2%B8sningJ)lJ)mg-ml.doc. Accessed December 2007. 

At the time of submission, applicants should have validated the methods that comprise the stability-indicating profile, and the data should be available for review. The determination of which tests should be included will be product-specific. The items emphasized in the following subsections are not intended to be all-inclusive, but represent product characteristics that should typically be documented to demonstrate product stability adequately. 

The key document from which all other text is derived, is the summary of product characteristics (SPC), sometimes referred to as the summary of major product characteristics (SmPC) to differentiate it, as abbreviated, from the supplementary protection certificate which is concerned with patent protection. 

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