EU-documents with significance to legislation of anthroposophic medicinal products

Communication from the Commission to the Council and the European Parliament 
concerning the 
Report on the experience acquired as a result of the application of the provisions of Chapter 2a of Directive 2001/83/EC, as amended by Directive 2004/24/EC, on specific provisions applicable to traditional herbal medicinal products Document on the basis of Article 16i of Directive 2001/83
(Brussels,29.9.2008, COM(2008) 584 final 
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Directive 2001/83/EC of the European Parliament and the Council of 6 November 2001 on the Community Code relating to medicinal products for human use. The consolidation of all the EU-Directives on medicinal products for human use, including the homeopathic medicinal products
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Article 5 (pdf)
Article 10a (pdf)
Article 14 (pdf)
Article 16 (pdf)

Summary of the public consultations responses (14.2.2008) ENTR/F/2/UN/lc D(2007) 1636
Report on the experience aquired as a result of the application of the provisions of Chapter 2A of Directive 1001/83/EC (introduced by Directive 2004/24/EC) on specific provisions appliacable to traditional herbal medicinal products, as required under Article 16.1 of Directive 2001/83/EC
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Draft
Communication from the Commission to the Council and the European Parliament (2007)Report on the experience acquired as a result of the application of the provisions of Chapter 2a of Directive 2001/83/EC (introduced by Directive 2004/24/EC) on specific provisions applicable to traditional herbal medicinal products
Document on the basis of article 16i of Directive 2001/83/EC
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Previous documents with impact on Directive 2001/83/EC

Council Directive 75/318/EEC of 20 May 1975 on the approximation of the laws of Member States relating to analytical, pharmaco-toxicological and clinical standards and protocols in respect of the testing of proprietary medicinal products
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Second Council 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
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Commission Directive 1999/83/EC of 8 September 1999 amending the Annex to Council Directive 75/318/EEC on the approximation of the laws of the Member States relating to analytical, pharmacotoxicological and clinical standards and protocols in respect of the testing of medicinal products (Text with EEA relevance)
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Council Directive 92/73/EEC of 22 September 1992 widening the scope of Directives 65/65/EEC and 75/319/EEC on the approximation of provisions laid down by Law, Regulation or Administrative Action relating to medicinal products and laying down additional provisions on homeopathic medicinal products
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Report of 28 October 1998 on the Commission report to the European Parliament and Council on the application of Directives 92/73/EEC and 982/74/EEC on homeopathic medicinal products. Rapporteur Mr Raphaël Chanterie (COM(97)362 - C4-0484/97)
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A European approach to non-conventional medicines. Doc. 8435. 11 June 1999. Report Social, Health and Family Affairs Committee: Rapporteur: Ms Lara Ragnarsdóttir. 
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