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Browse 15,090 regulations from 36 regulators
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Showing 401–450 of 484 regulations
LS9 0NX, Waste Organics (Leeds) Limited: environmental permit application advertisement - EPR/FB3701UA/V006
Environmental permit application advertisement for Waste Organics (Leeds) Limited facility in Leeds, UK. The application relates to waste organics processing operations and is subject to permitting review under Environmental Permitting Regulations.
Environment Agency issues new permit for Davidstow creamery
The Environment Agency has issued a permit variation to Saputo Dairy UK for their creamery facility near Davidstow, Cornwall, following a public consultation.
TN21 9NX, Christine Walker: environmental permit application advertisement - EPR/CP3324MF/A001
Environmental permit application advertisement for an operation at Cotteswood, Churches Green Lane, Heathfield, TN21 9NX, submitted by Christine Walker under permit reference EPR/CP3324MF/A001.
NR34 7LN, Balfour Beatty Civils Limited: environmental permit application advertisement - EPR/WP3728MQ/A001
Balfour Beatty Civils Limited submitted an environmental permit application for Benacre Pumping Stations at Lothingland Station in Beccles, NR34 7LN. This is a public advertisement of the permit application.
Premarket Tobacco Product Applications
21 CFR Part 1114 establishes procedures and requirements for submitting premarket tobacco product applications (PMTAs) to the FDA, including evaluation procedures and postmarket reporting obligations. The regulation defines key terms such as tobacco product accessories, additives, adverse experiences, brand characteristics, and composition, and specifies the scope of applicability, excluding premium cigars and modified risk tobacco product applications unless they seek dual marketing orders.
Gastroenterology-Urology Devices
21 CFR Part 876 establishes the classification and regulatory framework for gastroenterology-urology devices intended for human use in commercial distribution. The regulation outlines premarket approval requirements, including that Class III devices require FDA approval via premarket approval application (PMA) or product development protocol (PDP) before commercial distribution, with specified grace periods for devices marketed before May 28, 1976, and mandatory approval for new devices introduced after that date.
Medical Device Classification Procedures
21 CFR Part 860 establishes the procedures and criteria for classifying and reclassifying medical devices intended for human use into one of three regulatory control classes (I, II, or III) based on safety and effectiveness. The regulation defines classification criteria, describes the roles of advisory committees and the FDA Commissioner, and prescribes the data required to support device classification determinations. It also governs public participation and information disclosure in classification proceedings.
Quotas
This regulation establishes procedures for DEA quotas on Schedule I and II controlled substances. It defines three quota types—aggregate production, individual manufacturing, and procurement—and five subcategories covering commercial sale, transfers, product development, and replacement of disposed material. Quotas limit the total and per-manufacturer quantities of controlled substance APIs that may be produced or procured annually for pharmaceutical manufacturing.
Medicated Feed Mill License
21 CFR Part 515 establishes the licensing requirements for medicated feed mills manufacturing animal feeds containing new animal drugs. Applicants must submit Form FDA 3448 with facility details, FDA registration number, responsible personnel information, and certifications confirming compliance with good manufacturing practices, applicable drug regulations, and record-keeping requirements. The FDA Center for Veterinary Medicine reviews applications within 90 days, and supplemental applications are required for ownership or address changes.
Cardiovascular Devices
21 CFR Part 870 establishes FDA classification and regulatory requirements for cardiovascular devices intended for human use. The regulation outlines premarket approval (PMA) requirements for Class III devices, substantially equivalent device determinations under 510(k) submissions, and effective dates for compliance. Manufacturers must demonstrate substantial equivalence to existing devices or obtain FDA premarket approval before commercial distribution, with grace periods specified for devices classified before May 28, 1976.
Orthopedic Devices
21 CFR Part 888 establishes FDA classification and regulatory requirements for orthopedic devices intended for human use in commercial distribution. Devices classified as Class III require premarket approval (PMA) or completed product development protocol (PDP) before marketing, with specific effective dates and grace periods outlined. Manufacturers must demonstrate substantial equivalence to existing devices via premarket notification submissions.
General Hospital and Personal Use Devices
21 CFR Part 880 establishes the regulatory classification and premarket approval requirements for general hospital and personal use devices intended for human use in commercial distribution. The regulation defines the scope of device classification, requires manufacturers to demonstrate substantial equivalence, and specifies that Class III devices require FDA premarket approval before commercial distribution, with grace periods for devices marketed before May 28, 1976.
Immunology and Microbiology Devices
21 CFR Part 866 establishes the regulatory classification framework for immunology and microbiology devices intended for human use in commercial distribution. The regulation defines scope, premarket approval requirements, and effective dates for Class III devices, requiring FDA approval via premarket approval (PMA) or product development protocol (PDP) before commercial distribution, with specified grace periods for devices marketed before May 28, 1976.
General
21 CFR Part 1105 establishes FDA's premarket submission requirements for tobacco products. The regulation specifies grounds for refusing to accept applications, including submissions that lack required contact information, English translation, proper FDA forms, product identification details, environmental assessments, or a U.S. agent signature for foreign applicants. Accepted submissions receive a tracking number and processing acknowledgement.
Physical Medicine Devices
21 CFR Part 890 establishes the FDA classification framework for physical medicine devices intended for human use in commercial distribution. The regulation outlines premarket approval requirements, including class III device approval timelines and substantial equivalence determinations. Manufacturers must demonstrate why their devices are substantially equivalent to existing devices and comply with applicable premarket notification procedures under 21 CFR Part 807.
Ear, Nose, and Throat Devices
21 CFR Part 874 establishes FDA classification and regulatory requirements for ear, nose, and throat (ENT) medical devices intended for human use in commercial distribution. The regulation outlines premarket approval procedures, including requirements for Class III devices to obtain FDA approval via premarket approval (PMA) or product development protocol (PDP) before commercialization, with specified grace periods for devices marketed before May 28, 1976, and mandatory immediate approval for new or substantially altered devices.
Neurological Devices
21 CFR Part 882 establishes the FDA regulatory framework for neurological devices intended for human use in commercial distribution. The regulation sets forth device classification requirements and premarket approval procedures, specifying that class III neurological devices require FDA premarket approval (PMA) or completed product development protocol (PDP) before commercial distribution, with grace periods for devices marketed before May 28, 1976, but not for new devices introduced after that date.
Anesthesiology Devices
21 CFR Part 868 establishes the FDA classification framework for anesthesiology devices intended for human use in commercial distribution. The regulation outlines premarket approval requirements for Class III devices, defines substantial equivalence standards for premarket notification submissions, and specifies effective dates for FDA approval orders. Manufacturers must demonstrate substantial equivalence to existing devices or obtain premarket approval (PMA) or product development protocol (PDP) clearance before commercial distribution.
Radiology Devices
21 CFR Part 892 establishes the regulatory framework for radiology devices intended for human use in commercial distribution. The regulation sets out device classification requirements, premarket approval procedures, and exemption limitations. Manufacturers must demonstrate substantial equivalence to existing devices and comply with FDA approval requirements based on device class, with specific grace periods and effective dates governing commercial distribution of new or substantially altered radiology devices.
Importation and Exportation of Controlled Substances
21 CFR Part 1312 establishes procedures for importation, exportation, and transshipment of controlled substances. Importers must obtain DEA authorization through registration and permits (for Schedules I-II and certain Schedule III-V substances) or import declarations (for other Schedule III-V substances). Each shipment requires separate authorization, and applicants must submit detailed information including drug names, dosage forms, NDC numbers, and quantities on DEA Form 357 through the DEA Diversion Control Division secure network.
Premarket Approval of Medical Devices
21 CFR Part 814 establishes the premarket approval (PMA) process for Class III medical devices intended for human use. The regulation defines procedures for FDA review to ensure devices are safe and effective before market introduction, applies to devices not on the market before May 1976 or those required by regulation to obtain PMA approval, and sets conditions for approval and supplemental applications.
Establishment Registration and Device Listing for Manufacturers and Initial Importers of Devices
21 CFR Part 807 establishes registration and device listing requirements for manufacturers and initial importers of medical devices. The regulation defines key terms including commercial distribution, establishment, manufacture, official correspondent, and initial importer. It outlines exemptions from commercial distribution requirements, including internal transfers within affiliated companies, investigational use devices, and certain pre-1976 Class III devices. Device manufacturers and importers must register establishments annually and maintain current officer/director information with the FDA.
General and Plastic Surgery Devices
21 CFR Part 878 establishes the FDA classification framework for general and plastic surgery devices intended for human use in commercial distribution. The regulation outlines premarket approval requirements, particularly for Class III devices, which must obtain FDA approval via premarket approval (PMA) or product development protocol (PDP) before commercial distribution unless exempt or reclassified. Manufacturers must demonstrate substantial equivalence and comply with applicable regulatory submission procedures.
Registration of Manufacturers, Distributors, Importers and Exporters of List I Chemicals
This regulation establishes registration requirements for manufacturers, distributors, importers, and exporters of List I chemicals under DEA jurisdiction. Registration is mandatory for entities handling ephedrine, pseudoephedrine, phenylpropanolamine, and other designated List I chemicals. Annual fees apply: $3,699 for manufacturers and $1,850 for distributors, importers, and exporters. Registration must be submitted online via the DEA's secure portal with payment by ACH transfer or credit card. Separate registrations are required for independent activities (manufacturing, distributing, importing, exporting).
Registration of Manufacturers, Distributors, and Dispensers of Controlled Substances
21 CFR Part 1301 establishes registration procedures for manufacturers, distributors, dispensers, importers, and exporters of controlled substances under the Controlled Substances Act. Every person engaged in these activities must obtain DEA registration unless exempt. Online pharmacies must obtain a modified registration to dispense controlled substances via the Internet. Separate registrations are required for each principal place of business where such activities occur.
Hematology and Pathology Devices
21 CFR Part 864 establishes the regulatory framework for hematology and pathology devices intended for human use in commercial distribution. It outlines classification requirements, premarket approval timelines for Class III devices, and exemptions from premarket notification under section 510(k) of the Federal Food, Drug, and Cosmetic Act. Manufacturers must demonstrate substantial equivalence to existing devices and comply with applicable FDA guidance.
Ophthalmic Devices
21 CFR Part 886 establishes the FDA regulatory framework for ophthalmic devices intended for human use in commercial distribution. The regulation sets forth device classifications, premarket notification requirements under part 807, and premarket approval (PMA) procedures for class III devices. Manufacturers must demonstrate substantial equivalence to existing devices or obtain FDA approval before commercial distribution, with specific grace periods and effective dates specified for different device categories introduced before or after May 28, 1976.
Importation and Exportation of List I and List II Chemicals
21 CFR Part 1313 establishes procedures for importing, exporting, transshipping and in-transit shipment of List I and List II chemicals under the Chemical Diversion and Trafficking Act. Importers and exporters must notify the DEA at least 15 days before importing chemicals meeting threshold quantities, file declarations on DEA Form 486/486A, establish documented business relationships with customers, and maintain required records including supplier information and transaction frequency.
ME20 7XE, Elliott Environmental Drainage Limited: second environmental permit application advertisement - EPR/ZP3623LZ/A001
Elliott Environmental Drainage Limited has submitted a second environmental permit application for a facility located at Unit 1, St Michaels Close, Aylesford, UK. This advertisement notifies the public of the permit application under environmental permitting regulations.
LN2 3PU, Annyalla Chicks (UK) Broiler Breeders Limited: environmental permit application advertisement - EPR/MP3621LD/A001
Environmental permit application advertisement for Annyalla Chicks (UK) Broiler Breeders Limited's Welton Cliff Poultry Farm in Lincoln, UK under the Environmental Permitting Regulations.
HR3 5ER, Owen Dady: environmental permit application advertisement - EPR/PP3928MD/A001
Environmental permit application advertisement for an operation at The Wain House, Clifford, Hereford, Herefordshire, submitted by Owen Dady under permit reference EPR/PP3928MD/A001.
PE10 0AL, Ms Laura Cuthbertson: environmental permit application advertisement - EPR/GP3424MW/A001
Environmental permit application advertisement for a property at The Bungalow, Meadow Drive, Bourne, PE10 0AL, submitted by Ms Laura Cuthbertson under reference EPR/GP3424MW/A001.
TS2 1UB, Cumbria Waste Recycling Limited: environmental permit application advertisement - EPR/YP3424LH/A001
Environmental permit application advertisement by Cumbria Waste Recycling Limited for a hazardous waste transfer station at Seal Sands, Middlesborough, requiring regulatory approval under UK environmental permitting regulations.
National Policy Statements for energy infrastructure
Energy National Policy Statements provide planning guidance for developers of nationally significant energy infrastructure projects in the UK, establishing criteria and procedures for permitting and constructing major energy facilities.
Draft National Policy Statement for fusion energy generation (EN-8)
UK government consultation on a National Policy Statement to guide planning and regulatory decisions for fusion energy infrastructure development and deployment.
Technical Regulation — Equipment and Protective Systems Intended for Use in Potentially Explosive Atmospheres
Saudi Arabian technical regulation mandating design, certification, and labeling requirements for equipment and protective systems used in potentially explosive atmospheres. Applies to oil & gas, refinery, and petrochemical operations operating in classified hazardous zones. Establishes conformity assessment and compliance marking procedures.
PL32 9XW, Dairy Crest Limited: environmental issued - EPR/BN6137IK/V013
Environmental permit issued to Dairy Crest Limited for Davidstow Creamery in Camelford under the Industrial Emissions Directive, regulating emissions from dairy processing operations.
Tracer tests and remediation schemes: environmental permit exemption
UK guidance on registration requirements for discharging small quantities of substances in groundwater tracer tests and remediation schemes conducted for scientific purposes, including exemptions from standard environmental permitting.
CO6 3DU, Lanswood Limited: environmental permit application advertisement - EPR/FP3724MJ/A001
Lanswood Limited has submitted an environmental permit application for Barn Conversion A at Hall Road, Colchester, CO6 3DU, requiring public notice and review under UK environmental permitting regulations.
BB5 5TA, United Utilities Water Limited: environmental permit application advertisement - EPR/FB3144KX
United Utilities Water Limited submitted an environmental permit application for a combined sewer overflow (CSO) facility at Lower Barnes Street, Clayton-Le-Moors, Lancashire. This is a standard permitting advertisement for water infrastructure operations.
TA7 0AT, Richard Watts: environmental permit application advertisement - EPR/MP3528MT/A001
Environmental permit application advertisement for Richard Watts at Maple Durham, Moorland, Bridgwater, TA7 0AT (EPR/MP3528MT/A001). Specific permit details and regulated activities are not detailed in the provided excerpt.
DE4 4BW, Mr Christopher Sheppard and Mr Jamie Ogilvie: environmental permit application advertisement - EPR/EP3224MF/A001
Environmental permit application advertisement for The Lilies, Griffe Grange Valley, Matlock, submitted by Christopher Sheppard and Jamie Ogilvie under EPR/EP3224MF/A001.
TA7 0JL, Russel Monkhouse: environmental permit application advertisement - EPR/VP3725MV/A001
Environmental permit application advertisement for Dairy House Barn, a dairy operation located in Stathe, Bridgwater. This is a standard permitting notice published by UK environmental regulators regarding the application submitted by Russel Monkhouse.
NG9 6DY, Severn Trent Water Limited: low risk permit surrender issued EPR/UP3603MG/S002
Low risk permit surrender issued for Severn Trent Water Limited's Toton Sewage Treatment Works under the Industrial Emissions Directive, allowing the facility to cease regulated operations.
Assessing and scoring environmental permit and licence compliance
UK guidance on how the Environment Agency assesses and scores compliance with environmental permits, abstraction licences and impounding licences, establishing the criteria and methodology for evaluating permit holder adherence to regulatory requirements.
SK13 8ES, Plater Chemicals Limited: environmental permit application advertisement – EPR/AP3737GA/V004
Environmental permit application advertisement for Plater Chemicals Limited's Glossop Metal Salts facility in Glossop, UK. The application EPR/AP3737GA/V004 is submitted for regulatory review.
Morecambe Offshore Wind Farm Generation Assets: Correction of errors, Planning Act 2008
The Secretary of State has made corrections to the Development Consent Order for the Morecambe Offshore Wind Farm Generation Assets, a renewable energy project under the Planning Act 2008. This decision addresses errors in the original consent documentation for the offshore wind generation facility.
NR11 7AR, Peter Downs: environmental permit application advertisement - EPR/LP3225MD/A001
Environmental permit application advertisement for Itteringham Mill in Norwich under reference EPR/LP3225MD/A001, submitted by Peter Downs.
EA to lead environmental regulation of Trelavour Lithium Project
The UK Environment Agency will lead environmental regulation of Cornish Lithium's lithium production project at a former china clay pit in Cornwall.
DY9 9TS, Mary Hughes: environmental permit application advertisement - EPR/HP3024MH/A002
Environmental permit application advertisement for a facility at Mead End, Galtons Lane, Stourbridge, DY9 9TS, submitted by Mary Hughes under reference EPR/HP3024MH/A002.