Product Dossier definition

Product Dossier means file(s) containing detailed technical information of a
Product Dossier means such package of technical and clinical information concerning the Product as is necessary for, or useful in connection with, obtaining and maintaining Regulatory Approval for the Product in the Territory and includes, without limitation, the package insert, data in support of registered indications, bioequivalency data and information, clinical data, pharmaco toxicological data, analytical methods, stability and pharmaceutical data concerning the Product in the possession or control of PERNIX.

Examples of Product Dossier in a sentence

The clinical trial protocol and any applicable documentation (e.g., Investigational Medicinal Product Dossier, Subject Information and ICF) will be submitted or notified to the Health Authorities in accordance with the regulations of the countries involved in the trial.

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).

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

WHO Guidance on Variations To A Prequalified Product Dossier, 20075.

In parallel with the Investigational Medicinal Product Dossier (IMPD), an Investigator's Brochure (IB) is required, which outlines all available preclinical and clin- ical data (6).

The results of these studies as well as the comprehensive descriptions of proposed human clinical studies are then submitted as part of the IND application to the FDA, its Canadian equivalent, a Clinical Trial Application, to Health Canada, or its European equivalent, an Investigational Medicinal Product Dossier, to the EMA.

A separate Investigational Medicinal Product Dossier (IMPD) will provide the detail of this process.

Against this background, this study dealt with situational analysis of the organization of Directly Observed Treatment (DOT), insight into the difficulties encountered in implementing and delivering DOT services in different geographic regions and the problems faced by patients in utilizing the DOT services during treatment.

WHO Prequalification – Diagnostic Assessment: Instructions for Compilation of a Product Dossier.


More Definitions of Product Dossier

Product Dossier means Customer’s product dossier for the Products.

Related to Product Dossier

Product Data means illustrations, standard schedules, performance charts, instructions, brochures, diagrams and other information furnished by the Contractor to illustrate materials or equipment for some portion of the Work.
Product means the product being manufactured, even if it is intended for later use in another manufacturing operation;
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;
Drug Product means a specific drug in dosage form from a known source of manufacture, whether
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.
Licensed Product means any product or part thereof which:
Collaboration Product means any product that contains one or more Discovered RNAi Compound(s) as active ingredient(s).
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.
Product Documentation means the specific materials listed under “Product Documentation” at vocera.com/legal, as updated by Vocera from time to time.
DMF means a Drug Master File for Captisol, as filed as of the Effective Date, or as hereafter updated from time to time during the Term, by CyDex with the FDA.
MFDA means the Mutual Fund Dealers Association of Canada;
Finished Product means a cannabis product in its final form to be sold at a retail premises.
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.”
U.S. Territory means American Samoa, the Commonwealth of the Northern Mariana Islands, Guam, the Commonwealth of Puerto Rico, or the U.S. Virgin Islands.
Covered Product means the eligible wireless device owned by you and for which the unique identification number (International Mobile Equipment Identity (IMEI), Electronic Serial Number (ESN), Mobile Equipment ID (MEID), or Serial Number) is on record with us when the Wireless Device first fails to operate properly. To be considered Covered Product, the wireless device must have logged outgoing airtime with your Wireless Service Provider after the request for coverage for the Covered Product and within sixty (60) days prior to reporting the Wireless Device failure, and for which You can provide Us proof of ownership.
Tobacco product manufacturer means an entity that after the date of enactment of this Act directly (and not exclusively through any affiliate):
Product Manufacturer means the entity that assembles the component parts to manufacture the final Product;
Territory means worldwide.
Therapeutic Product means a health product categorised as a therapeutic product in the First Schedule to the Act;
Licensed Territory means worldwide.
Approved Product means any water fitting, plumbing product, material or component which is the subject of an existing WRAS Approval;
Drug means (A) articles recognized in the official United States Pharmacopoeia, official Homeopathic Pharmacopoeia of the United States or official National Formulary, or any supplement to any of them; (B) articles intended for use in the diagnosis, cure, mitigation, treatment or prevention of disease in humans or other animals; (C) articles, other than food, intended to affect the structure or any function of the body of humans or any other animal; and (D) articles intended for use as a component of any articles specified in this subdivision; but shall not include devices or their components, parts or accessories;
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.
customs territory means the territory of the country of each Contracting Party in which the Customs laws of that country are in force;
Licensed Compound means (a) 3,4-Diaminopyridine, the chemical structure of which is set forth on Exhibit B-2; and (b) any derivatives, isomers, metabolites, prodrugs, acid forms, base forms, salt forms, or modified versions of such compound in (a).
Biologics License Application means a Biologics License Application, as defined in the U.S. Federal Food, Drug, and Cosmetics Act, as amended, and the regulations promulgated thereunder, and any corresponding foreign or domestic marketing authorization application, registration or certification, necessary or reasonably useful to market a Collaboration Product in the Territory, but not including pricing and reimbursement approvals.