Investigational Medicinal Product Dossier definition

Investigational Medicinal Product Dossier means TEKMIRA’s dossier on each Investigational Medicinal Product to be used in the Clinical Trial, compiled in accordance with applicable law and submitted by TEKMIRA to the United States Food and Drug Administration or any successor agency thereof (“FDA”) in support of an application for Regulatory Approval.
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Investigational Medicinal Product Dossier means, in relation to an investigational medicinal product, the dossier relating to that product which accompanies a request for authorisation to conduct a trial in which that product is or is to be used, in accordance with paragraph 11 of Schedule 3;
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Investigational Medicinal Product Dossier means a dossier relating to the Investigational Medicinal Product which accompanies a request for clinical trial authorisation to conduct the Clinical Trial from a Regulatory Authority. The Investigational Medicinal Product Dossier shall include a specification of the IMP.
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Examples of Investigational Medicinal Product Dossier in a sentence

  • Therefore, the proposed actions should focus on late preclinical (e.g. validation in animal models, toxicology, Good Manufacturing Practices (GMP) production, preparation of Investigational Medicinal Product Dossier) and early clinical (up to phase 1) development of already existing lead drug and vaccine candidates.

  • Please refer to the SmPC and Investigational Medicinal Product Dossier (IMPD) for more details about the active and placebo IMPs. Ratiopharm Spironolactone does not have any special storage conditions (Please see Appendix 1: 6.4 Special Precautions For Storage).

  • There are specific considerations in case of substantial modifications to the Investigational Medicinal Product Dossier (IMPD).

  • References to literature and data that are relevant and form the basis for the trial." In the Danish Medicines Agency's view the information about investigational medicinal products, including information about the products' quality, previous trials and toxicological studies, which for example is gathered in the Investigator's Brochure or the Investigational Medicinal Product Dossier (IMPD), is to be considered as forming part of the trial protocol.

  • Further information on REALIST ORBCEL-C and Plasma-Lyte 148 (placebo control) can be obtained from the Investigational Medicinal Product Dossier (IMPD).

  • Despite any award or other provision to the contrary, absence on maternity leave does not break the continuity of service of an employee but should not be taken into account in calculating the period of service for any purpose of any relevant award or agreement.

  • Please refer to the Summary of Product Characteristics and Investigational Medicinal Product Dossier (IMPD) for more details about the active and placebo IMPs.

  • TEKMIRA shall grant OXFORD, permission to provide the applicable Regulatory Authorities reference access to TEKMIRA’s Investigational Medicinal Product Dossier in a timely manner sufficient to meet OXFORD’s obligations under this Agreement.

  • TEKMIRA shall, in relation to the Investigational Medicinal Product, be responsible for compiling the Investigational Medicinal Product Dossier.

  • EANM guideline for the preparation of an Investigational Medicinal Product Dossier (IMPD).


More Definitions of Investigational Medicinal Product Dossier

Investigational Medicinal Product Dossier means TEKMIRA’s dossier on each Investigational Medicinal Product to be used in the Clinical
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Investigational Medicinal Product Dossier filed or to be filed with Regulatory Authorities in the European Union. 1.33. “Inventions” means all inventions and discoveries, whether or not patentable, that are made, conceived, or first actually reduced to practice by or on behalf of a Party, or by or on behalf of the Parties together, [***]. 1.34. “Joint Development Committee” or “JDC” has the meaning set forth in Section 3.10.1. 1.35. “Joint Patent Application” has the meaning set forth in Section 10.1.1(c). 1.36. “Joint Patent” means a Patent that issues from a Joint Patent Application. 1.37. “Jointly Owned Invention” has the meaning set forth in Section 10.1.1(a). 1.38. “Know-How” means any proprietary invention, innovation, improvement, development, discovery, computer program, device, trade secret, method, know-how, process, technique or the like, including manufacturing, use, process, structural, operational and other data and information, whether or not written or otherwise fixed in any form or medium, regardless of the media on which contained and whether or not patentable or copyrightable, that is not generally known or otherwise in the public domain. 1.39. “Liability” has the meaning set forth in Section 14.2.1.
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Investigational Medicinal Product Dossier or “IMPD” filed or to be filed as part of the application to the relevant Regulatory Authority). 1.45 “Indication” means a disease (a) for which a Licensed Product is indicated for treatment and (ii) that is described in the Licensed Product label as required by the Regulatory Approval granted by the applicable Regulatory Authority. An Indication is only distinct from another Indication (a) if the diseases associated with such Indications are listed in two (2) different blocks of the ICD-10 and (b) Regulatory Approvals are based, in whole or in part, on separate clinical studies. 1.46 “Japan” means Japan, including its territories and possessions. 1.47 “Joint Inventions” has the meaning set forth in Clause 1.10 of Exhibit G. 1.48 “Joint Patent Agreement” has the meaning set forth in Clause 1.10 of Exhibit G. 1.49 “Joint Patents” has the meaning set forth in Clause 1.10 of Exhibit G. 1.50 “Know-How” means know-how, trade secrets, chemical and biological materials, formulations, information, documents, studies, results, data and regulatory approvals, data (including from Clinical Studies), filings and correspondence (including DMFs), including biological, chemical, pharmacological, toxicological, pre-clinical, clinical and assay data, manufacturing processes and data, specifications, sourcing information, assays, and quality control and testing procedures, whether or not patented or patentable. 1.51 “Knowledge” means the actual knowledge of a Party or any of its Affiliates without any duty of inquiry. 1.52 “Law” means any federal, state, provincial, local, international or multinational law, statute, standard, ordinance, code, rule, regulation, resolution or promulgation, or any order, writ, judgment, injunction, decree, stipulation, ruling, determination or award entered by or with any Governmental Authority, or any license, franchise, permit or similar right granted under any of the foregoing, or any similar provision having the force or effect of law. 6
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Investigational Medicinal Product Dossier filed or to be filed with Regulatory Authorities in the European Union.
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Investigational Medicinal Product Dossier filed or to be filed with the EMA. 1.62 “Initiation” means, with respect to a Clinical Study, the dosing of the first patient in such Clinical Study. 1.63 “Intellectual Property Rights” means all patents, inventions (whether patentable or not), discoveries, rights in confidential information, Know-How and trade secrets (and any documents containing such confidential information, Know-How or trade secrets), trademarks and service marks, copyrights (including in computer software) (in each case whether registered or not), registered designs, design rights, contractual waivers of moral rights, rights in databases and collections of data, utility models and all similar property rights whether or not registered or registrable, designs, drawings, performances, computer
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Related to Investigational Medicinal Product Dossier

  • Investigational Medicinal Product means the study drug or control material as defined in the Protocol.

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

  • 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;

  • FDA means the United States Food and Drug Administration.

  • Final Product means a product that is not used in producing other products and is built and intended for use outdoors, provided the final product has not deteriorated or has otherwise become a potential source of contaminants.

  • Manufacturing Know-How means, with respect to the Product or any Variant thereof, the technology, data, designs, processes, methods, specifications and other know-how used in connection with the formulation, manufacture, labeling, packaging, quality control, release testing, and production of the Product, and all ingredients used therein and portions thereof.

  • Manufacturing Process means any process for—

  • cGMP means current Good Manufacturing Practice as set forth in the United States Federal Food, Drug, and Cosmetic Act, as amended, and includes all rules and regulations promulgated by the FDA thereunder.

  • Drug Product means a specific drug in dosage form from a known source of manufacture, whether

  • Clinical laboratory means a facility for the microbiological, serological, chemical, hematological, radiobioassay, cytological, immunohematological, pathological, or other examination of materials derived from the human body for the purpose of providing information for the diagnosis, prevention, or treatment of a disease or assessment of a medical condition.

  • 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.

  • Drug Approval Application means, with respect to a Licensed Product in the Territory, an application for Regulatory Approval for such product in a country in the Territory. For purposes of clarity, Drug Approval Application shall include, without limitation, (a) an NDA or BLA (for U.S.) or MAA (for Europe); (b) a counterpart of an NDA, BLA or MAA in any country or region in the Territory; and (c) all supplements (including supplemental applications such as sNDAs) and amendments to the foregoing.

  • Medical marijuana product means a product that contains cannabinoids that have been extracted from plant material or the resin therefrom by physical or chemical means and is intended for administration to a licensed patient, including but not limited to concentrates, oils, tinctures, edibles, pills, topical forms, gels, creams, and other derivative forms, except that this term does not include live plant forms.

  • Regulatory Approval Application means an application to seek regular or expedited Regulatory Approval of the Licensed Product for sale or marketing in any country(ies) or Region(s) in the Territory, as defined in the applicable Laws and filed with the Regulatory Authority of such country(ies) or Region(s).

  • Marketing Approval Application or “MAA” means a New Drug Application (or its equivalent), as defined in the U.S. Food, Drug and Cosmetic Act and the regulations promulgated thereunder, or any corresponding or similar application, registration or certification in any country.

  • MFDA means the Mutual Fund Dealers Association of Canada;

  • Biologics License Application or “BLA” means an application requesting permission from the FDA to introduce, or deliver for introduction, a biological product into interstate commerce, or any similar application or submission for marketing authorization of a product filed with a Regulatory Authority to obtain Regulatory Approval for such product in a country or group of countries.

  • DMF means any drug master file filed with the FDA, and any equivalent filing in other countries or regulatory jurisdictions.

  • Product Labeling means, with respect to a Licensed Product in a country or other jurisdiction in the Territory, (a) the Regulatory Authority-approved full prescribing information for such Licensed Product for such country or other jurisdiction, including any required patient information, and (b) all labels and other written, printed, or graphic matter upon a container, wrapper, or any package insert utilized with or for such Licensed Product in such country or other jurisdiction.

  • Phase I Clinical Study means, as to a particular Licensed Product, an initial clinical study in humans with the purpose of assessing the Licensed Product’s safety, tolerability, toxicity, pharmacokinetics or other pharmacological properties.

  • CFDA means the Code of Federal Domestic Assistance assigned to a federal grant.

  • Phase 4 Clinical Trial means a Clinical Study in any country which is conducted after Regulatory Approval of a product has been obtained from an appropriate Regulatory Authority, consisting of trials conducted voluntarily for enhancing marketing or scientific knowledge of an approved indication and trials conducted due to request or requirement of a Regulatory Authority.

  • 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.”

  • Phase I Clinical Trial means a study in humans which provides for the first introduction into humans of a product, conducted in normal volunteers or patients to generate information on product safety, tolerability, pharmacological activity or pharmacokinetics, or otherwise consistent with the requirements of U.S. 21 C.F.R. §312.21(a) or its foreign equivalents.

  • Drug Substance means an active ingredient that is intended to furnish pharmacological activity or other direct effect in the diagnosis, cure, mitigation, treatment, or prevention of disease or to affect the structure or any function of the human body, but does not include intermediates used in the synthesis of such ingredient.

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