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Directive 2001/83/EC of the European Parliament and of the

Directive 75/319/EEC of 20 May 1975 on the approximation of provisions laid down by law, regulation or administrative action relating to proprietary medicinal products (5) , Council Directive 89/342/EEC of 3 May 1989 extending the scope of Directives



This document is meant purely as a documentation tool and the

M10 Directive 2010/84/EU of the European Parliament and of the Council of 15 December 2010 L 348 74 31 12 2010 M11 Directive 2011/62/EU of the European Parliament and of the Council of 8 June 2011 L 174 74 1 7 2011 M12 Directive 2012/26/EU of the European Parliament and of the Council of 25 October 2012 L 299 1 27 10 2012 Corrected by:



Directive 2001/83/EC of the European Parliament and of the

amending Directive 2001/83/EC on the Community code relating to medicinal products for human use F2 Inserted by Directive 2004/27/EC of the European Parliament and of the Council of 31 March 2004 amending Directive 2001/83/EC on the Community code relating to medicinal products for human use



This document is meant purely as a documentation tool and the

M7 Directive 2008/29/EC of the European Parliament and of the Council of 11 March 2008 L 81 51 20 3 2008 M8 Directive 2009/53/EC of the European Parliament and of the Council of 18 June 2009 L 168 33 30 6 2009 M9 Commission Directive 2009/120/EC of 14 September 2009 L 242 3 15 9 2009 Corrected by:



The drugs tracking system in Italy - Homepage GS1

Parliament and Council Directive 2001/83/CE The last, in the introduction, point 35, says: “It is necessary to exercise control over the entire chain of distribution of medicinal products, from their manufacture or import into the Community through to supply to the public, so as to guarantee that such products are stored,



The drug tracking system in Italy - Homepage GS1

The EU Parliament and Council Directive 2001/83/CE, article 35, declares: “It is necessary to exercise control over the entire chain of distribution of medicinal products, The requirements which must be adopted for this purpose will considerably facilitate the withdrawal of



COMMITTEE FOR MEDICINAL PRODUCTS FOR HUMAN USE (CHMP

medicinal products of the Annex I to Directive 2001/83/CE as amended 5 ASPECTS TO POTENCY TESTING OF CELL BASED IMMUNOTHERAPY PRODUCTS Appropriately designed potency assays provide an accurate, reliable and consistent demonstration of the biological activity of the active ingredient either at the level of drug substance and/or drug product



María Jesús Lamas Díaz Agencia Española de Medicamentos y

Directive 2001/83/CE: Advanced therapies are not cited; Annex I comprises the analytical, pharmaco-toxicological and clinical rules and

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