Chapter 2.
A Question oft Delimination
Companies in the food, pharmaceutical, and cosmetics industries are constantly on the lookout for new products to add to and round off their portfolio. If, in the course of an in-depth search in the growth area of healthcare, they come across OTC drugs or medical products, for example, then a phase of disenchantment often sets it.
Companies in the food, pharmaceutical, and cosmetics industries are constantly on the lookout for new products to add to and round off their portfolio. If, in the course of an in-depth search in the growth area of healthcare, they come across OTC drugs or medical products, for example, then a phase of disenchantment often sets it.
The regulatory demands and quality standards that have to be satisfied in an area that does not belong to their core competence soon create the impression that such products are unprofitable. In such situations, however, everything is a question of
delimitation - in this case between distribution, manufacturing and production. The demands on a licence to place medical products or drugs on the market are clearly stipulated in EU directives and national legislation. Thus since July 2006 manufacturers of medical devices of higher classes have to fulfil the quality standard DIN EN ISO 13485:2003. A cosmetics company which wishes to extend its product portfolio by a single medical product, such as a tooth whitener, suddenly faces a considerable certification effort. In addition, the time-to- market of the new product is significantly lengthened by the necessary reorganisation of the existing quality management systems.
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