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 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);
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Examples of Directive 2001/83 in a sentence

  • 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.

  • Nor, on this approach, was there is any inconsistency between Novartis and Synthon, since the adaptation provided that a Swiss marketing authorisation recognised in Liechtenstein was to be treated as an authorisation in accordance with Directive 2001/83.

  • The application is being made under Article 10(a) of Directive 2001/83 as amended, and accordingly no additional toxicological, pharmacological or clinical efficacy studies have been performed.

  • This application is being made under Article 10(a) of Directive 2001/83 as amended, and accordingly no additional toxicological, pharmacological or clinical efficacy studies have been performed.

  • Pcy "as defined in" is a more appropriate legal drafting in point (b) since some medicinal products are excluded from Directive 2001/83, by virtue of Art.

  • However, the marketing authorisation holder shall submit periodic safety update reports for this medicinal product if the product is included in the list of Union reference dates (EURD list) provided for under Article 107c(7) of Directive 2001/83 and published on the European medicines web-portal.

  • The application was submitted under Article 16a traditional use registration for herbal medicinal products of the Directive 2001/83 EC, as amended.

  • 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.


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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Related to Directive 2001/83

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

  • 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.

  • 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.

  • the 2001 Regulations means the Water Supply (Water Quality) Regulations 2001[63];

  • 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

  • Payroll Tax Executive Order means the Presidential Memorandum on Deferring Payroll Tax Obligations in Light of the Ongoing COVID-19 Disaster, as issued on August 8, 2020 and including any administrative or other guidance published with respect thereto by any Governmental Authority (including IRS Notice 2020-65).

  • 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 means a requirement for the Inspection, repair or modification of the Engine or any portion thereof as issued by Airworthiness Authorities.

  • 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.

  • Applicable MREL Regulations means, at any time, the laws, regulations, requirements, guidelines and policies then in effect in Norway giving effect to any MREL Requirement or any successor regulations then applicable to the Issuer, including, without limitation to the generality of the foregoing, CRD, the BRRD and those regulations, requirements, guidelines and policies giving effect to any MREL Requirement or any successor regulations then in effect (whether or not such requirements, guidelines or policies have the force of law and whether or not they are applied generally or specifically to the Issuer or to the Issuer and its subsidiaries);

  • Legislative Assembly means Legislative Assembly of Union territory of Jammu and Kashmir;

  • 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”.

  • PPPFA Regulations means the Preferential Procurement Regulations, 2017 published in terms of the PPPFA.

  • Environmental and Social Management Framework or “ESMF” means the framework included in the EA 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.

  • Advance health care directive means a power of attorney for health care or a record signed or authorized 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

  • 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;