Directive 2001/83 definition

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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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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Examples of Directive 2001/83 in a sentence

  • According to Article 46a (1) of Directive 2001/83 and Article 50a (1) of Directive 2001/82, manufacture includes complete or partial manufacture, import, dividing up, packaging or presentation prior to its incorporation into a medicinal product, including re-packaging or re-labelling as carried out by a distributor.

  • Attention was also drawn to the distinction made in Directive 2001/83 between “active substances” and “excipients”, the latter being defined as “any constituent of a medical product other than the active substance and the packaging material”.

  • For recommendations to the marketing authorisation not falling under Article 21a/22 of Directive 2001/83 and conditions to the marketing authorisation pursuant to Article 21a or 22 of Directive 2001/83/EC to the marketing authorisation, please see section VI.

  • In addition, it is of course beyond discussion that the four cases mentioned in the Code of Conduct (sub-section 5.1.2) or the Medicines Act (and Directive 2001/83) respectively, to which the Code of Conduct or the Medicines Act (and the Directive) respectively do not apply, must at any rate be considered as information.

  • Upon completing the manufacture of each batch of devices referred to in Article 1(4a), the manufacturer shall inform the notified body of the release of the batch of devices and send to it the official certificate concerning the release of the batch of human blood derivative used in the device, issued by a State laboratory or a laboratory designated for that purpose by a Member State in accordance with ►M5 Article 114(2) of Directive 2001/83/ EC ◄.ANNEX III EC TYPE-EXAMINATION ▼M5 ▼B1.

  • Articles 7 and 8 shall not apply to products authorised under Articles 10, 10a, 13 to 16 or 16a to 16i of Directive 2001/83/ EC.

  • It is not registered anywhere else in the EU, except in Malta where it is registered under article 126 of Directive 2001/83 of the EU which allows registration for public health reasons.

  • However, to the extent that the activities in question(2007), health insurance (2007) and physician services (2008) and the Swedish NCA report on consumer welfare in health (2008).242 Case C-62/2009 Association of the British Pharmaceutical Industry v Medicines and Healthcare Products Regulatory Agency [2010] ECR243 Article 94(1) of Directive 2001/83 of the European Parliament and of the Council of 6 November 2001 on the Community code relating to medicinal product for human use (OJ L 311, 28.11.2004, p.

  • Europeans Medicines Agency, Guideline on the risk-based approach according to annex I, part IV of Directive 2001/83/ EC applied to advanced therapy medicinal products, 11 February 2013, EMA/CAT/CPWP/686637/2011.

  • Therefore, the Authority concludes that the method of classifying medicinal products in Norway in this regard is in accordance with Article 1(2) of Directive 2001/83.

Related to Directive 2001/83

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

  • Council Directive means Council Directive 89/552/EEC of 3 October 1989 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 1997 and by Directive 2007/65/EC of the European Parliament and of the Council of 11 December 2007. A simplified and codified version of these Directives was introduced in 2010: the Audiovisual Media Services Directive 2010/13/EU.

  • CRD Directive means Directive 2013/36/EU of the European Parliament and of the Council of 26 June 2013 on access to the activity of credit institutions and the prudential supervision of credit institutions and investment firms, amending Directive 2002/87/EC and repealing Directives 2006/48/EC and 2006/49/EC (as amended from time to time, including by Directive (EU) 2019/878 of the European Parliament and of the Council of 20 May 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.

  • Industrial Emissions Directive means DIRECTIVE 2010/75/EU OF THE EUROPEAN PARLIAMENT AND OF THE COUNCIL of 24 November 2010 on industrial emissions

  • Waste Framework Directive or “WFD” means Waste Framework Directive 2008/98/EC of the European Parliament and of the Council on waste

  • Construction Change Directive means a written order prepared by Owner Parties and signed by Owner directing Contractor to perform a change in the Work prior to agreeing to a change, if any, to the Contract Time, schedule of performance of the Work, Contract Sum, or Contractor’s compensation.

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

  • Environmental, Health or Safety Requirements of Law means all Requirements of Law derived from or relating to foreign, federal, state and local laws or regulations relating to or addressing pollution or protection of the environment, or protection of worker health or safety, including, but not limited to, the Comprehensive Environmental Response, Compensation and Liability Act, 42 U.S.C. § 9601 et seq., the Occupational Safety and Health Act of 1970, 29 U.S.C. § 651 et seq., and the Resource Conservation and Recovery Act of 1976, 42 U.S.C. § 6901 et seq., in each case including any amendments thereto, any successor statutes, and any regulations or guidance promulgated thereunder, and any state or local equivalent thereof.

  • Directives means intergovernmental, interagency, or interdepartment administrative or procedural guidelines or instructions which do not affect the rights of, or procedures and practices available to, the public.

  • Directive means EC Council Directive 2001/23/EC

  • Solvency II Directive means Directive 2009/138/EC of the European Parliament and of the Council of the European Union of 25 November 2009 on the taking-up and pursuit of the business of insurance and reinsurance (Solvency II);

  • Airworthiness Directive or “AD” means any airworthiness directive issued by the Certificating Authority, in addition to any airworthiness directive issued by the Aeronautics Authority, each to the extent the same is applicable to the Aircraft and/or any Item of Equipment.

  • UCITS Directive means Directive 2009/65/EC of the European Parliament and of the Council of 13 July 2009 on the coordination of laws, regulations and administrative provisions relating to undertakings for collective investment in transferable securities, as amended;

  • Certified Domestic Violence Specialist means a person who has fulfilled the requirements of certification as a Domestic Violence Specialist established by the New Jersey Association of Domestic Violence Professionals.

  • Legislative Assembly means the Legislative Assembly constituted under the provisions of Article 44.

  • Labor law decision means an administrative merits determination, arbitral award or decision, or civil judgment, which resulted from a violation of one or more of the laws listed in the definition of “labor laws”.

  • Environmental and Social Management Framework or “ESMF” means the framework disclosed in country on September 13, 2010 and at the Association’s Infoshop on September 14, 2010, in form and substance satisfactory to the Association, setting out modalities to be followed in assessing the potential adverse environmental and social impact associated with activities to be implemented under the Project, and the measures to be taken to offset, reduce, or mitigate such adverse impact.

  • National Ambient Air Quality Standards or “NAAQS” means national ambient air quality standards that are promulgated pursuant to Section 109 of the Act, 42 U.S.C. § 7409.

  • Advance health care directive means a power of attorney for health care or a record signed by a prospective donor containing the prospective donor's direction concerning a health care decision for the prospective donor.

  • Implement of husbandry means a vehicle that is designed for agricultural purposes and

  • relevant minimum wage means the minimum wage and includes any incremental adjustment prescribed in this award for the class of work for which an employee is engaged

  • Advance directive means a document that contains a health care instruction or a power of attorney for health care.

  • Municipal Finance Management Act means the Local Government: Municipal Finance Management Act, 2003 (Act No. 56 of 2003);

  • Adult abuse means the willful infliction of physical pain, injury or mental anguish or unreasonable

  • Involuntary Resettlement Safeguards means the principles and requirements set forth in Chapter V, Appendix 2, and Appendix 4 (as applicable) of the SPS;