Directive 2001/83 definition

Directive 2001/83 means Directive 2001/83/EC of 6 November 2001 on the Community code relating to medicinal products for human use (and any amended and/or successor legislation applicable to the UK);
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Directive 2001/83 means Directive 2001/83/EC of the European Parliament and of the Council of 6th November 2001 on the Community Code relating to medicinal products for human use(6);
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Directive 2001/83 means Directive 2001/83/EC of the European Parliament and of the Council of 6th November 2001 on the Community Code relating to medicinal products for human use F12[F13as amended by Directive 2002/98/EC of the European Parliament and of the Council setting standards of quality and safety for the collection, testing, processing, storage‌
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Examples of Directive 2001/83 in a sentence

  • In the EU, the legal framework for ATMPs is laid down in the European Regulation (EC) No. 1394/2007, known as the ATMP regulation, amending Directive 2001/83/ EC and Regulation (EC) No. 726/2004.

  • The Supplier shall maintain, and no later than any date on which it would otherwise expire, obtain a renewal of the Marketing Authorisation in accordance with the provisions of Directive 2001/83 and where applicable the Medicines for Human Use (Marketing Authorisations Etc.) Regulations 1994.

  • Each Party shall be responsible for its own compliance with Applicable Law with respect to its Product Samples program, including, with respect to the EU, Article 96 of Directive 2001/83, and shall bear its own costs relating to such compliance, which shall not be included in Allowable Expenses (other than indirectly to the extent covered by the applicable FTE Rate).

  • With regard to chemical supplied under the Purchase Order within or into the European Union, Supplier herewith confirms that it is fully aware of UE Regulation No. 1907/2006 on Registration, Evaluation, Authorization and Restriction of Chemicals (“REACH”) and of UE Directive 2001/83 on Medicinal Products for Human Use (“MPHU”) and any Italian implementing law and regulation .


More Definitions of Directive 2001/83

Directive 2001/83 means Directive 2001/83/EC of the European Parliament and of the Council on the Community code relating to medicinal products for human use(9) as last amended by Directive 2009/53/EC of the European Parliament and of the Council amending Directive 2001/82/EC and Directive 2001/83/EC, as regards variations to the terms of marketing authorisations for medicinal products(10);
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Directive 2001/83 means Directive 2001/83/EC of 6 November 2001 on the Community code relating to medicinal products for human use (and any implementing, amended and/or successor legislation applicable to the UK or any part of it); “Directive 2003/94” means Directive 2003/94/EC of 8 October 2003 laying down the principles and guidelines of good manufacturing practice in respect of medicinal products for human use and investigational medicinal products for human use (and any implementing, amended and/or successor legislation applicable to the UK or any part of it);
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