Food and Drug Regulations definition

Food and Drug Regulations means the Laws that are, have been or may in the future be issued, enacted, adopted, passed, approved, promulgated, made, implemented or otherwise put into effect by or under the authority of the FDA or pursuant to the U.S. Food, Drug, and Cosmetic Act, as amended, its implementing regulations in Title 21 of the Code of Federal Regulations, and any similar provisions of state law.
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Food and Drug Regulations means the requirements set out in the Food and Drugs Act for the manufacture, packaging, labelling, storage, importation, distribution and sale of foods, and prescription and non-prescription drugs in Canada;
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Food and Drug Regulations means the Food and Drug Regulations, C.R.C. c. 870. “For Cause Audit” has the meaning set forth in Section 6.21.‌‌‌‌‌‌
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Examples of Food and Drug Regulations in a sentence

  • Product shall have been manufactured, packaged, stored and shipped in accordance with good manufacturing practices based on the provisions of the Commonwealth of Australia Food and Drug Regulations (including amendments).4.

  • The purpose of a Temporary Marketing Authorization is to generate information in support of a proposed amendment to the Food and Drug Regulations.

  • As sponsor of the study, the grant recipient is responsible for reporting SAEs and Lack of Therapeutic Efficacy directly to Health Canada (pursuant to the Canadian Food and Drug Regulations) and to the local REB, as required.

  • Sterling IRB operates in compliance with: • Protection of Human Subjects (DHHS), 45 CFR 46• FDA Regulations on Human Subjects Research, 21 CFR 50 and 56• Part C Division 5 of the Canadian Food and Drug Regulations and the Tri-Council Policy Statement (where applicable)• International Conference on Harmonisation guidelines for Good Clinical Practice (ICH E6) The IRB reviews and monitors research involving human subjects.

  • As sponsor of the study, the grant recipient is responsible for reportingSAEs and Lack of Therapeutic Efficacy directly to Health Canada (pursuant to the Canadian Food and Drug Regulations) and to the local REB, as required.

  • Health Canada, Food and Drug Regulations, Part C, Division 5, Drugs for Clinical Trials Involving Human Subjects, (Schedule 1024), June 20, 2001.

  • For example: Canada’s Food and Drug Regulations require certain clinical trial records to be stored for twenty-five (25) years and research conducted in provincial hospitals may be subject to The Hospital Standards Regulations, 1980 (Saskatchewan).

  • Within the majority of members plus one, at least five of the members with the appropriate representative capacities stipulated under section C.05.001 of the Food and Drug Regulations as stipulated in the list above, must vote in favor of the approval.

  • Product shall have been manufactured, packaged, stored and shipped in accordance with good manufacturing practices based on the provisions of the Commonwealth of Australia Food and Drug Regulations (including amendments).

  • Canada’s Food and Drugs Act and the associated Food and Drug Regulations strictly control the use of food additives.

Related to Food and Drug Regulations

  • FFDCA means the United States Federal Food, Drug, and Cosmetic Act, 21 U.S.C. §301 et seq., as amended from time to time, together with any rules, regulations and requirements promulgated thereunder (including all additions, supplements, extensions, and modifications thereto).

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

  • FDA means the United States Food and Drug Administration and any successor agency thereto.

  • Food and food ingredients means substances, whether in liquid, concentrated, solid, frozen, dried, or dehydrated form, that are sold for ingestion or chewing by humans and are consumed for their taste or nutritional value. Food and food ingredients do not include alcoholic beverages and tobacco.

  • Drug abuse means any pattern of pathological use of drugs that causes impairment in social or occupational functioning, or that produces physiological dependency evidenced by physical tolerance or by physical symptoms when it is withdrawn.

  • FCC Regulations means the regulations duly and lawfully promulgated by the FCC, as in effect from time to time.

  • SEBI Regulations means the Securities and Exchange Board of India (Listing Obligations and Disclosure Requirements) Regulations, 2015 together with the circulars issued thereunder, including any statutory modification(s) or re-enactment(s) thereof for the time being in force.

  • Legend drugs means any drugs which are required by state

  • FD&C Act means the United States Federal Food, Drug, and Cosmetic Act (21 U.S.C. § 301 et seq.), as amended, and the rules and regulations promulgated thereunder.

  • New Drug Application or “NDA” means a new drug application filed with a Regulatory Authority (not including pricing and reimbursement approval), that is analogous to the new drug application with the United States Food and Drug Administration described in 21 C.F.R. § 314.

  • Prescription drug order means an original or new order from a practitioner for drugs, drug-related devices or treatment for a human or animal, including orders issued through collaborative care agreements. Lawful prescriptions result from a valid practitioner-patient relationship, are intended to address a legitimate medical need, and fall within the prescribing practitioner's scope of professional practice;

  • national regulatory authority means the body or bodies charged by a Member State with any of the regulatory tasks assigned in this Directive and the Specific Directives;

  • PPPFA Regulations means the Preferential Procurement Regulations, 2017 published in terms of the PPPFA.

  • Governmental Regulations means all statutes, ordinances, rules and regulations of the Authorities applicable to Seller or the use or operation of the Real Property or the Improvements or any portion thereof.

  • Legend drug or "prescription drug" means any drug or device that has been determined to be unsafe for self- medication or any drug or device that bears or is required to bear the legend:

  • Foreign Financial Regulatory Authority shall have the meaning given by Section 2(a)(50) of the 0000 Xxx.

  • Drug addiction means a disease characterized by a

  • CFTC Regulations means the rules and regulations promulgated by the CFTC, as amended.

  • Public health authority means an agency or authority of the United States, a state, a territory, a political subdivision of a state or territory, an Indian tribe, or a foreign government, or a person or entity acting under a grant of authority from or contract with such public agency, including the employees or agents of such public agency or its contractors or persons or entities to whom it has granted authority, that is responsible for public health matters as part of its official mandate.

  • foreign regulatory authority means a securities commission, exchange or other securities market regulatory authority in a designated foreign jurisdiction;

  • MHLW means the Japanese Ministry of Health, Labour and Welfare, and any successor agency thereto.

  • EU Regulation means a regulation within the meaning of Article 288 of the Treaty on the Functioning of the European Union;

  • EP Regulations means The Environmental Permitting (England and Wales) Regulations SI 2016 No.1154 and words and expressions used in this permit which are also used in the Regulations have the same meanings as in those Regulations.

  • PDMA means the Prescription Drug Marketing Act of 1987, as amended, and the regulations promulgated thereunder from time to time.

  • Council of governments means a decision-making body in each county composed of membership including the county governing body and the mayors of each municipality in the county.

  • Federal Regulations means those federal regulations relating to cable television services, 47 C.F.R. Section 76.1 et seq. (and, to the extent applicable, any other federal rules and regulations relating to cable television, including but not limited to, those described in 47 C.F.R. Section 76.3), or as such regulations may be amended.