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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Related to Directive 2001/83

  • CRD V Directive means Directive 2019/878 as regards exempted entities, financial holding companies, mixed financial holding companies, remuneration, supervisory measures and powers and capital conservation measures of the European Parliament and of the Council of 20 May 2019 amending Directive 2013/36/EU, as the same may be amended or replaced from time to time;

  • Change Directive means a written order signed by the procurement officer that

  • Council Directive means Council Directive 89/552/EEC of 3 October 19891 on the co-ordination of certain provisions laid down by law, regulation or administrative action in Member States concerning the pursuit of television broadcasting activities as amended by Directive 97/36/EC of the European Parliament and of the Council of 30 June 19972 and by Directive 2007/65/EC of the European Parliament and of the Council of 11 December 20073;

  • CRD Directive means the Directive (2013/36/EU) of the European Parliament and of the Council on prudential requirements for credit institutions and investment firms dated 26 June 2013 and published in the Official Journal of the European Union on 27 June 2013 (or, as the case may be, any provision of Danish law transposing or implementing such Directive), as amended or replaced from time to time (including, for the avoidance of doubt, the amendments to such Directive resulting from Directive (EU) 2019/878 of the European Parliament and of the Council as regards exempted entities, financial holding companies, mixed financial holding companies, remuneration, supervisory measures and powers and capital conservation measures dated 20 May 2019 and published in the Official Journal of the European Union on 7 June 2019);

  • CRD IV Directive means Directive 2013/36/EU on access to the activity of credit institutions and the prudential supervision of credit institutions and investment firms of the European Parliament and of the Council of 26 June 2013, as the same may be amended or replaced from time to time.