Licence to Manufacture definition

Licence to Manufacture means the conditional rights to manufacture granted to Bayer under Clause 2.4 of the Licence and Distribution Agreement and more particularly described in Clause 8.2 of this Agreement.
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Examples of Licence to Manufacture in a sentence

  • Guideline for a Licence to Manufacture, Import, Export or Distribute Medical Devices and IVDs. Pretoria: MCC, 2016:1-10.www.mccza.com/Publications/DownloadDoc/5483 (accessed 23 January 2018).

  • Purchase and sale of medicines, medical devices, IVDs and Scheduled substances by wholesalers.The relevant Regulations are as follows: General Regulation 23- Licence to Manufacture, Import, Export, Act as a Wholesaler of or Distribute Medicines or Scheduled SubstancesGeneral Regulation 24- Period of validity and renewal of Licence issued in terms of Regulation 23.

  • The expiry date of the certificate is the same as that of the corresponding licence to manufacture pharmaceutical products.A pplication for a Licence to Manufacture Dangerous Drugs A manufacturer of dangerous drugs is required to hold an additional licence issued by the Director of Health under the Dangerous Drugs Ordinance, Cap.

  • The holder of a Licence to Manufacture Medicines or a Licence to Pack Medicines under the Medicines Act 1981 has responsibilities including the following.

  • To obtain a Licence to Manufacture Medicines and/or a Licence to Pack Medicines under the Medicines Act 1981, you must demonstrate that you comply with the GMP Code.

  • The NSW licence must be obtained first by applying for an annual Licence to Manufacture and Supply by Wholesale, Drugs of Addiction.

  • In the case of justice as fairness, the first priority rule of liberty over all else values freedom over equality.

  • Points on which clarifications sought as per committeerecommendations Response to the clarifications sought Recommendation(I) Submission of DCGI approval for the quoted product(II) Confirmation regarding provision of carrier RNA on free of cost along with the quoted RNA extraction kit.(I) Submitted MD-9 (Licence to Manufacture for Sale or for Distribution of Class C or Class D medical device) issued in favour of M/s Genuine Biosystem Private Limited.

  • In deciding whether one venue is more convenient to witnesses than another, we “should not limit [our] investigation to a review of which party can produce the longer witness list.” Vandeveld, 877 F.

  • This licence permits the holder to pack and label medicines only.To obtain a Licence to Manufacture Medicines or a Licence to Pack Medicines, you must be able to demonstrate that you comply with the New Zealand Code of Good Manufacturing Practice for Manufacture and Distribution of Therapeutic Goods (the GMP Code).For more information about licences to manufacture and/or pack medicines, see the Medsafe website.

Related to Licence to Manufacture

  • Supply Licence means the licence granted to us under section 6(1)(d) of the Act;

  • Manufacturing Know-How means all information, techniques, inventions, discoveries, improvements, practices, methods, knowledge, skill, experience and other technology, whether or not patentable or copyrightable, and any copyrights based thereon, relating to or necessary or useful for the production, purification, packaging, storage and transportation of Collaboration Products, including without limitation specifications, acceptance criteria, manufacturing batch records, standard operating procedures, engineering plans, installation, operation and process qualification protocols for equipment, validation records, master files submitted to the FDA, process validation reports, environmental monitoring processes, test data including pharmacological, toxicological and clinical test data, cost data and employee training materials.

  • 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.

  • Bulk drug substance means any substance that is represented for use, and that, when used in the

  • Manufacturing Technology means any and all patents, patent applications, know-how, and all intellectual property rights associated therewith that are owned or controlled by Licensor, and including all tangible embodiments thereof, that are necessary or useful for the manufacture of adeno-associated viruses, adeno-associated virus vectors, research or commercial reagents related thereto, Licensed Products, or other products, including manufacturing processes, technical information relating to the methods of manufacture, protocols, standard operating procedures, batch records, assays, formulations, quality control data, specifications, scale up, any and all improvements, modifications, and changes thereto, and any and all activities associated with such manufacture. Any and all chemistry, manufacturing, and controls (CMC), drug master files (DMFs), or similar materials provided to regulatory authorities and the information contained therein are deemed Manufacturing Technology.

  • Manufacture means the production of products in a factory using labour, materials, components and machinery and includes other related value-adding activities.

  • Tobacco product manufacturer means an entity that after the date of enactment of this Act directly (and not exclusively through any affiliate):

  • 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 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.

  • Manufacturing Materials means parts, tools, dies, jigs, fixtures, plans, drawings, and information produced or acquired, or rights acquired, specifically to fulfill obligations set forth herein.

  • Third Party Manufacturer means any person, firm or company which carries out the reproduction of Work and/or manufactures and/or prints the Licensed Publication on behalf of the Licensee;

  • Manufactured end product means any end product in product and service codes (PSCs) 1000-9999, except—

  • Product Know-How means Know-How to the extent related to the properties, manufacture or use of any products.

  • Detailed manufacturing or process data means technical data that describe the steps, sequences, and conditions of manufacturing, processing or assembly used by the manufacturer to produce an item or component or to perform a process.

  • Product Manufacturer means the entity that assembles the component parts to manufacture the final Product;

  • Licence Term means the Initial Term plus any Further Term; Licensee means You and/or the Permitted Users;

  • Engine Manufacturer means CFM International, Inc.

  • Generation Licence means an electricity generation licence granted or treated as granted pursuant to section 6(1)(a) of the EA 1989 that authorises a person to generate electricity;

  • 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.

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

  • cGMP means current Good Manufacturing Practices as specified in the United States Code of Federal Regulations, ICH Guideline Q7A, or equivalent laws, rules, or regulations of an applicable Regulatory Authority at the time of manufacture.

  • Radiopharmaceutical quality assurance means, but is not limited to, the performance of appropriate chemical, biological, and physical tests on potential radiopharmaceuticals and the interpretation of the resulting data to determine their suitability for use in humans and animals, including internal test assessment, authentication of product history, and the keeping of proper records.

  • Modular building manufacturer means a person or corporation who owns or operates a

  • 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.

  • Good Manufacturing Practices means current good manufacturing practices, as set forth in 21 C.F.R. Parts 210 and 211.

  • Current Good Manufacturing Practices or “cGMP” means applicable Good Manufacturing Practices as specified in the United States Code of Federal Regulations and/or the EU Good Manufacturing Guidelines, and any successor legislation from time to time, prevailing at the time of the manufacture of the Product.