INFORMATION FROM EUROPEAN UNION INSTITUTIONS BODIES OFFICES AND AGENCIES.pdfVIP

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INFORMATION FROM EUROPEAN UNION INSTITUTIONS BODIES OFFICES AND AGENCIES.pdf

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INFORMATION FROM EUROPEAN UNION INSTITUTIONS BODIES OFFICES AND AGENCIES

II (Information) INFORMATION FROM EUROPEAN UNION INSTITUTIONS, BODIES, OFFICES AND AGENCIES EUROPEAN COMMISSION Guidelines of 19 March 2015 on principles of Good Distribution Practice of active substances for medicinal products for human use (Text with EEA relevance) (2015/C 95/01) Introduction These guidelines are based on the fourth paragraph of Article 47 of Directive 2001/83/EC (1). They follow the same principles that underlie the guidelines of EudraLex Volume 4, Part II, Chapter 17, with regard to the distribution of active substances and the Guidelines of 5 November 2013 on Good Distribution Practice of medici- nal products for human use (2). These guidelines provide stand-alone guidance on Good Distribution Practice (GDP) for importers and distributors of active substances for medicinal products for human use. They complement the rules on distribution set out in the guidelines of EudraLex Volume 4, Part II, and apply also to distributors of active substances manufactured by themselves. Any manufacturing activities in relation to active substances, including re-packaging, re-labelling or dividing up, are subject to Commission Delegated Regulation (EU) No 1252/2014 (3) and EudraLex Volume 4, Part II. Additional requirements apply to the importation of active substances, as laid down in Article 46b of Directive 2001/83/EC. Distributors of active substances for medicinal products for human use should follow these guidelines as of 21 September 2015. CHAPTER 1 — SCOPE 1.1. These guidelines apply to distribution of active substances, as defined in Article 1(3a) of Directive 2001/83/EC, for medicinal products for human use. According to that provision, an active substance is any substance or mix- ture of substances intended to be used in the manufacture of a medicinal product and that, when used in its production, becomes an active ingredient of that product intended to exert a pharmacological, immunological or metabolic action with a view to restoring,