In this section of GMP-inspection.com, our translators provide definitions and explanations of various specialized terms from the pharmaceutical industry and GMP (Good Manufacturing Practice).
Compulsory licenses are a mechanism provided for in international and national legal systems that allows a state or another rights holder to grant a third party (usually another company) the right to manufacture, use or sell a product or technology for which this third party does not have exclusive rights (patents, copyrights, etc.) without the consent of the rights holder and under certain conditions.
Compulsory licenses (German translation: Zwangslizenzen) can be applied in the following cases:
Compulsory licenses strike a balance between the rights of rights holders and the public interest, as they can serve to ensure that important products and technologies are available and accessible at times when they are critical to society. However, the compulsory licensing procedure is generally subject to strict legal and procedural conditions in order to ensure the fair and balanced use of this mechanism.
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