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Ingenious combination products and their legal permission procedure – what to get ready for?

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Many of the most ingenious medical solutions are indeed combinations between drugs and tools that in general include a part of medical device and a part of drug.

device contract

Autor: Centrum Naturhouse
Źródło: Centrum Naturhouse
Combined products are often medical devices coated or impregnated with a drug substance, for example a catheter with an antimicrobial coating or a pharmaceutical coated stent. Other examples of ingenious solutions involve bone-containing cements consisting of antibiotics and spermicide-coated contraceptives.
Despite the medical advantages offered by combined tools in the cure of certain medical cases, the procedure of administrative analysis and approval for combination products is generally more complicated than that applied to unbound products. For instance, in the EU, the assessment on medical inventions including medications should involve the judgement of a competent authority elected by the European Union member state. Combination product inventors are encouraged to estaplish a precise regulatory plan, as fast as possible, in the process of developing new combination products. An efficient regulatory project provides a complex plan to go through the invention permission process, coherent with the device contract and the manufacturer’s plans for its market inauguration. Inventors of combined solutions should also request the opinion of the adequate authorities and autonomous third parties as concerns the documentation to be presented in support of the CE marking norms.

These stages are used to make the authorization process as productive as possible and can support reducing the risk of sudden and contractual setbacks that might prolong or unable product authorization.

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