إجراء مقترح من الاتحاد الأوروبي: المنتجات الصيدلانية، الأدوية البيطرية، الأغذية

The proposal consists of measures targeted to strengthen the competitiveness of the biotechnology, structured in the following chapters: Chapter I – Subject Matter, Scope and Definitions, sets out the subject matter of this proposal, which consists of measures that articulate its overall objective to improve the functioning of the internal market by establishing a framework to strengthen the competitiveness of the biotechnology sector and specifies the scope of the proposal, which applies to health biotechnology products and services during their entire lifecycle, Chapter II – Union health biotechnology and biomanufacturing, introduces the concepts of health biotechnology strategic projects and high impact health biotechnology strategic projects and establishes a framework for the recognition and the support of such projects aimed at strengthening the EU’s industrial biomanufacturing capacity and value chains. Chapter III – Access to funding, establishes an EU health biotechnology investment pilot in partnership with the European Investment Bank Group and other implementing partners. Chapter IV – Extension of the supplementary protection certificate, introduces an extension of 12 months of the Supplementary Protection Certificate (SPC) for medicinal products developed by means of biotechnology processes and for Advanced Therapy Medicinal Products. Chapter V - Enhancing competitiveness in biosimilars, supports EU competitiveness in the field of biosimilars by encouraging the…