Pharmaceutical Affairs Law definition

Pharmaceutical Affairs Law means the Law on Securing Quality, Efficacy and Safety of Products Including Pharmaceuticals and Medical devices (Law No. 145 of 1960).
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Pharmaceutical Affairs Law means the Japanese Pharmaceutical Affairs Law (Law No. 145 of 1960), as amended, and all applicable enforcement ordinances.
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Pharmaceutical Affairs Law means the Act on Securing Quality, Efficacy and Safety of Products including Pharmaceuticals and Medical Devices. 1.56 “PMDA” means Japan’s Pharmaceuticals and Medical Devices Agency or any successor agency thereto. 7 ACTIVE/99458941.1
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Examples of Pharmaceutical Affairs Law in a sentence

  • Sublicensor and Sublicensee acknowledge that, pursuant to the Japanese Pharmaceutical Affairs Law, each foreign manufacturer of medical products with respect to each supplier of intermediates, Compound, formulated Compound (interim product) (if any) and/or Product, including any test or storage facility, for commercial supply is required to be accredited as of the time when Sublicensee files a marketing approval for Product in the Sublicensee Territory.

  • MTI and the Licensee acknowledge that, pursuant to the Japanese Pharmaceutical Affairs Law, MTI and its applicable manufacturing sites, including any test or storage facilities, are required to be accredited as of the time when the Licensee files for Regulatory Approval for Licensed Product in the Territory.

  • For each Product for which the approval of the MHW is required (I.E., for which a Shonxx xx necessary), Aspect shall obtain a Foreign Manufacturing Approval (I.E., Gaikoku Seizx Xxxxxx) xxd NK shall be Aspect's In-Country Caretaker (I.E., Kokunai Kanrinin, as this term is defined in 19-2 of Japan's Pharmaceutical Affairs Law).

  • For all completed study reports, the responsible Party shall provide necessary documentation to confirm data reliability, as required by Article 43 of the Japanese Pharmaceutical Affairs Law Enforcement Regulations and related notifications, including, but not limited to original author signatures, raw data lists, GLP and GCP compliance information.

  • For all completed study reports, BPM shall provide necessary documentation to confirm data reliability, as required by Article 43 of the Japanese Pharmaceutical Affairs Law Enforcement Regulations and related notifications, including, but not limited to original author signatures, raw data lists, GLP and GCP compliance information.

  • For all completed study reports for Licensed Products for such Collaboration Target in the Roche Territory, BPM shall provide to Roche necessary documentation to confirm data reliability, as required by Article 43 of the Japanese Pharmaceutical Affairs Law Enforcement Regulations and related notifications, including original author signatures, raw data lists, GLP and GCP compliance information.

  • For all completed study reports, PTC shall provide necessary documentation to confirm data reliability, as required by Article 43 of the Japanese Pharmaceutical Affairs Law Enforcement Regulations and related notifications, including, but not limited to original author signatures, raw data lists, GLP and GCP compliance information.

  • Seller is compliant with, but not registered or certified to: (i) Pharmaceutical Affairs Law 2002 (PAL) [Japan]; (ii) Medical Device Directive 93/42/EEC [Europe]; (iii) ISO 60601-1, and (iv) ISO 00000-0-0.

  • Siemens, through its subsidiary SAM, will take primary responsibility for and coordinate the regulatxxx process to achieve approval by the Ministry of Health, Labour and Welfare of Japan ("MHLW") under the Pharmaceutical Affairs Law to obtain regulatory clearance ("Shonin") for commercial use of the NIOBE System in Japan in a manner xxxx permits the Shonin to be transferred to Stereotaxis at Stereotaxis election, in xxx xxnner set out below.

  • MANUFACTURER is a foreign manufacturer which, at the point of this agreement, has no location in Japan and intends to obtain a special approval (Gaikoku Tokurei Xxxxxx Xxxxxxx Sha) issued by the Japanese Ministry of Health, Labour and Welfare (hereinafter referred to as “MHLW”) under the Japanese Pharmaceutical Affairs Law (Yakuji Hou) (hereinafter referred to as ‘PAL”) of certain in vitro diagnostics (Taigai Shindan Yo lyakuHin), which are categorized as drugs (lyakuhin) under PAL.

Related to Pharmaceutical Affairs Law

  • 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.

  • Pharmaceutical care means the provision of drug therapy and

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

  • Pharmaceutical means any compound or mixture, other than food, used in the prevention, diagnosis, alleviation, treatment, or cure of disease in human and animal.

  • Commercialization or “Commercialize” means activities directed to marketing, promoting, research and development as required, manufacturing for sale, offering for sale, distributing, importing or selling a product, including sub-licensing or sub-contracting of these activities.

  • Diagnostic clinical procedures manual means a collection of written procedures that describes each method (and other instructions and precautions) by which the licensee performs diagnostic clinical procedures; where each diagnostic clinical procedure has been approved by the authorized user and includes the radiopharmaceutical, dosage, and route of administration.

  • Commercialization Plan has the meaning set forth in Section 6.2.

  • Active Pharmaceutical Ingredient or “API” shall mean one or more of the following active pharmaceutical ingredients: tenofovir alafenamide (“TAF”), tenofovir disoproxil fumarate (“TDF”), elvitegravir (“EVG”), and cobicistat (“COBI”).

  • Commercial Development Plan means the written commercialization plan attached as Appendix E.

  • Commercial Development means any development on private land that is not heavy industrial or residential. The category includes, but is not limited to: hospitals, laboratories and other medical facilities, educational institutions, recreational facilities, plant nurseries, car wash facilities, mini-malls and other business complexes, shopping malls, hotels, office buildings, public warehouses and other light industrial complexes.

  • Civil Aeronautical Product means any civil aircraft, aircraft engine, or propeller or subassembly, appliance, material, part, or component to be installed thereon.

  • site development plan means a dimensioned plan drawn to scale that indicates details of the proposed land development, including the site layout, positioning of buildings and structures, property access, building designs and landscaping;

  • 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.

  • Distillery manufacturing license means a license issued in accordance with

  • Clinical means having a significant relationship, whether real or potential, direct or indirect, to the actual rendering or outcome of dental care, the practice of dentistry, or the quality of dental care being rendered to a patient;

  • Quality Assurance Plan or “QAP” shall have the meaning set forth in Clause 11.2;

  • 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.

  • Radiopharmaceutical means any drug that exhibits spontaneous disintegration of unstable nuclei with the emission of nuclear particles or photons and includes any non-radioactive reagent kit or radionuclide generator that is intended to be used in the preparation of any such substance, but does not include drugs such as carbon-containing compounds or potassium-containing salts that include trace quantities of naturally occurring radionuclides. The term also includes any biological product that is labeled with a radionuclide or intended solely to be labeled with a radionuclide.

  • Joint Commercialization Committee or “JCC” has the meaning set forth in Section 2.1(a).

  • Medical management technique means a practice which is used to control the cost or utilization of health care services or prescription drug use. The term includes, without limitation, the use of step therapy, prior authorization or categorizing drugs and devices based on cost, type or method of administration.

  • Research and development means (1) theoretical analysis, exploration, or experimentation; or (2) the extension of investigative findings and theories of a scientific or technical nature into practical application for experimental and demonstration purposes, including the experimental production and testing of models, devices, equipment, materials, and processes. Research and development does not include the internal or external administration of radiation or radioactive material to human beings.

  • Clinical Staff means those employees of a provider who are responsible for providing clinical services to clients.

  • Clinical nurse specialist means a registered nurse with relevant post-basic qualifications and 12 months’ experience working in the clinical area of his/her specified post-basic qualification, or a minimum of four years’ post-basic registration experience, including three years’ experience in the relevant specialist field and who satisfies the local criteria.

  • Radiopharmaceutical service means, but is not limited to, the procurement, storage, handling preparation, labeling, quality assurance testing, dispensing, delivery, recordkeeping, and disposal of radiopharmaceuticals and other drugs.

  • Manufacturing operation means a process in which materials are changed, converted, or transformed into a different state or form from which they previously existed and includes refining materials, assembling parts, and preparing raw materials and parts by mixing, measuring, blending, or otherwise committing such materials or parts to the manufacturing process. "Manufacturing operation" does not include packaging.

  • 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: