Advanced therapy medicinal product definition

Advanced therapy medicinal product means any of the following medicinal products for human use:
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Advanced therapy medicinal product means a product as defined in Article 2 of the advanced therapy regulation;
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Advanced therapy medicinal product means any of the fol- lowing medicinal products for human use:
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Examples of Advanced therapy medicinal product in a sentence

  • Advanced therapy medicinal product (ATMP): An ATMP is a medicinal product which is: a gene therapy medicinal product as defined in Part IV of Annex 1 to Directive 2001/83/EC; ora somatic cell therapy medicinal product as defined in Part IV of Annex 1 to Directive 2001/83/EC; or a tissue engineered product as defined in Article 2 1 (b) of the ATMP Regulation.

  • Advanced therapy medicinal product: A product as defined in Article 2 of Regulation (EC) No 1394/2007 of the European Parliament and of the Council of 13 November 2007 on advanced therapy medicinal products (1).

  • Advanced therapy medicinal product prepared on a non- routine basis for human or veterinary use may be prepared by a business entity holding the Agency’s authorisation for the preparation of advanced therapy medicinal products prepared on a non-routine basis in accordance with the quality standards and conditions for the preparation, stipulated hereby, in the framework of the issued authorisation.

  • Advanced therapy medicinal product containing devices as referred to in Article 7 of Regulation (EC) No 1394/2007.

  • A CHMP positive opinion or an MRDC positive end of procedure outcome is an RR approval for the purposes of IRP, with conditions where particular conditions will drive review, for example: • Designation of Orphan status• Advanced therapy medicinal product (ATMP) as classified by the HMRs 2012• At least one manufacturing site is not yet GMP certified.• The Environmental Risk Assessment (ERA) has not been assessed by the RR.• The Risk Management Plan (RMP) has not been assessed by the RR.

  • Advanced therapy medicinal product is a medicinal product defined in Article 2 of Regulation No 1394/2007/EC.


More Definitions of Advanced therapy medicinal product

Advanced therapy medicinal product means a gene therapy medicinal product, a somatic cell therapy medicinal product, a tissue engineered product, or a combined advanced therapy medicinal product manufactured industrially or by a method involving an industrial process;
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Advanced therapy medicinal product means a medicinal product described in Article 2(1)(a) of Regulation(EC) No 1394/2007;
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Advanced therapy medicinal product means a medicinal product intended for gene therapy or somatic cell therapy or a tissue engineered product specified in Regulation No 1394/2007/EC of the European Parliament and of the Council on advanced therapy medicinal products (OJ L 324, 10.12.2007, p. 121).
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Advanced therapy medicinal product means advanced therapy medicinal product as defined in Article 2(1), point (a), of Regulation (EC) No 1394/2007;
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Advanced therapy medicinal product means any medicinal product based on processes focused on various gene transfer-produced bio-molecules, and biologically advanced therapeutic modified cells and tissues as active substances or part of active substances.
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Advanced therapy medicinal product means gene therapy medicinal products, somatic cell therapy medicinal products, tissue engineered products, or combined advanced therapy medicinal products manufactured industrially or subjected to industrial processes;
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Related to Advanced therapy medicinal product

  • medicinal product means any substance or combination of substances presented for treating or preventing disease in human beings or animals and any substance or combination of substances which may be administered to human beings or animals with a view to making a medical diagnosis or to restoring, correcting or modifying physiological functions in humans or in animals;

  • in vitro diagnostic medical device means any medical device which is a reagent, reagent product, calibrator, control material, kit, instrument, apparatus, equipment, software or system, whether used alone or in combination, intended by the manufacturer to be used in vitro for the examination of specimens, including blood and tissue donations, derived from the human body, solely or principally for the purpose of providing information:

  • Pharmaceutical Product shall have the meaning ascribed to such term in Section 3.1(hh).

  • Aerosol coating product means a pressurized coating product containing pigments or resins that dispenses product ingredients by means of a propellant, and is packaged in a disposable can for hand-held application, or for use in specialized equipment for ground traffic/marking applications.

  • Aerosol product means a pressurized spray system that dispenses product ingredients by means of a propellant contained in a product or a product's container, or by means of a mechanically induced force. “Aerosol Product” does not include “Pump Spray.”

  • Biological product means a virus, therapeutic serum, toxin, antitoxin, vaccine, blood, blood component or derivative, allergenic product, protein other than a chemically synthesized polypeptide, or analogous product, or arsphenamine or any derivative of arsphenamine or any other trivalent organic arsenic compound, applicable to the prevention, treatment, or cure of a disease or condition of human beings.

  • Investigational Product means the Study Drug identified above and the control material, as further detailed in the Protocol;

  • Manufacturing Process means any process for—

  • Marijuana product means marijuana as defined in 50-32-101 and marijuana-infused products

  • Reference biological product means the single biological product licensed pursuant to 42 U.S.C.

  • Marijuana products means concentrated marijuana products and marijuana products that are comprised of marijuana and other ingredients and are intended for use or consumption, such as, but not limited to, edible products, ointments, and tinctures.

  • Collaborative drug therapy management means participation by an authorized pharmacist and a physician in the management of drug therapy pursuant to a written community practice protocol or a written hospital practice protocol.

  • Tobacco product means any substance containing tobacco leaf, including but not limited to, cigarettes, cigars, pipe tobacco, hookah tobacco, snuff, chewing tobacco, dipping tobacco, bidis, blunts, clove cigarettes, or any other preparation of tobacco; and any product or formulation of matter containing biologically active amounts of nicotine that is manufactured, sold, offered for sale, or otherwise distributed with the expectation that the product or matter will be introduced into the human body by inhalation; but does not include any cessation product specifically approved by the U.S. Food and Drug Administration for use in treating nicotine or tobacco dependence.

  • Active Pharmaceutical Ingredient or “API” means the active pharmaceutical or biological ingredient as further set forth in the applicable Product Manufacturing Plan.

  • Tobacco product manufacturer means an entity that after the date of enactment of this act directly (and not exclusively through any affiliate) meets 1 or more of the following:

  • Step therapy protocol means a protocol or program that establishes the specific

  • Cannabis product means cannabis that has undergone a process whereby the plant material has been transformed into a concentrate, including, but not limited to, concentrated cannabis, or an edible or topical product containing cannabis or concentrated cannabis and other ingredients.

  • Tobacco products means cigars, cigarettes, cheroots, stogies, periques, granulated, plug cut, crimp cut, ready rubbed, and other smoking tobacco, snuff, snuff flour, moist snuff, cavendish, ping and twist tobacco, fine-cut and other chewing tobaccos, shorts, refuse scraps, clippings, cuttings and sweepings of tobacco, and other kinds and forms of tobacco, prepared in such manner as to be suitable for chewing or smoking in a pipe or otherwise, or both for chewing and smoking.

  • Commercial Product means any such product as defined in FAR 2.101.