UK Statutory Instrument SI 2018/677 United Kingdom

The Health Service Products (Provision and Disclosure of Information) Regulations 2018

Read it on legislation.gov.uk (opens in a new tab)
Status
In Force
Penalty ceiling
Regulated 1 of 22 obligations carry a criminal penalty. 21 have no criminal penalty — flagged in the list below.

Does it bind you?

Business-side roles with duties under this instrument.

Manufacturer20 Employer1 Any Person1

Other Acts binding the same actors

If a role above is yours, these are the other instruments that most often bind it.

Manufacturer — also bound by 502 other Acts
Employer — also bound by 682 other Acts
TULRCA 1992 72 duties
Any Person — also bound by 2340 other Acts

What it requires

Regulations creating concrete business duties or carrying penalties, grouped as the instrument is structured. Titles link to the source text — blue means you’re leaving for legislation.gov.uk.

s.007 Information to be recorded and kept about supply of unbranded generic health service medicines: manufacturers and importers Regulated
  • Record and keep supply information for unbranded generic health service medicinesManufacturer
s.008 Information to be recorded and kept about supply of unbranded generic health service medicines: medicines wholesalers Regulated
  • Record and keep information on unbranded generic medicine purchases and suppliesManufacturer
s.009 Requirement to provide information about supply of unbranded generic health service medicines Regulated
  • Provide quarterly information about unbranded generic health service medicinesManufacturer
s.011 Information to be recorded about supply of made special health service medicines: manufacturers Regulated
  • Record supply information for made special health service medicinesManufacturer
s.012 Information to be recorded about supply of made special health service medicines: medicines wholesalers Regulated
  • Record purchase and supply details of made special health service medicinesManufacturer
s.013 Information to be recorded and kept about supply of imported special health service medicines: medicines wholesalers and importers Regulated
  • Record and keep purchase and supply information for imported special health service medicinesManufacturer
s.014 Requirement to provide information about the supply of special health service medicines Regulated
  • Provide quarterly information on supply of special health service medicinesManufacturer
s.016 Information to be recorded and kept about supply of imported special health service medicines: medicines wholesalers and importers Regulated
  • Record and keep information about purchases and supplies of imported special health service medicinesManufacturer
s.017 Information to be recorded and kept about supply of health service medicines other than imported special health service medicines: medicines wholesalers Regulated
  • Record and keep purchase and supply information for health service medicines (wholesalers)Manufacturer
s.018 Information to be recorded and kept about supply of health service medicines other than imported special health service medicines: other UK producers Regulated
  • Record and keep supply details for health service medicinesManufacturer
s.019 Information to be recorded and kept about supply of health service medicines to patients otherwise than by sale Regulated
  • Record and keep purchase information for health service medicines supplied to patientsManufacturer
s.020 Information to be recorded and kept about supply of health service appliances: manufacturers and importers Regulated
  • Record and keep supply details for health service appliancesManufacturer
s.022 Information to be recorded and kept about supply of appliances, food and dermatological products to patients otherwise than by sale Regulated
  • Record and keep supply information for certain health products provided free to patientsManufacturer
s.023 Provision of information recorded and kept under this Part to the Secretary of State Regulated
  • Provide retained information to the Secretary of State when requestedManufacturer
s.024 Provision of information: small producers Regulated
  • Provide net NHS sales income when requested as a specific small producerManufacturer
s.025 Provision of information about costs incurred in connection with the manufacture or distribution of a particular health service medicine or appliance Regulated
  • Provide cost information to the Secretary of State when requestedManufacturer
s.026 Provision of general information about costs incurred in connection with the manufacture or distribution of health service medicines and appliances Regulated
  • Provide cost information requested by the Secretary of StateManufacturer
s.027 Provision of information about English health service medicines which are not available at the reimbursement price Regulated
  • Provide requested information on medicine availability and pricing within 2 working daysManufacturer
s.028 Provision of information about availability of health service medicines Regulated
  • Provide information on medicine availability when requested by the Secretary of StateManufacturer
s.030 Requirement to provide information about reasonable estimates Regulated
  • Provide reasons and method when using reasonable estimatesManufacturer
s.031 Compliance procedure Regulated
  • Comply with a compliance notice issued by the Secretary of StateEmployer
s.032 Penalties Regulated
  • Fail to comply with information or compliance noticeAny Person
14 other provisions — procedural and definitional
s.001 Citation and commencement
s.002 Interpretation: general
s.003 Application
s.004 Exception: products not known to be health service products
s.005 Information required to be provided via an NHS England online gateway
s.006 Meaning of “unbranded generic health service medicine” and listing of a presentation of unbranded generic health service medicine
s.010 Meaning of “special health service medicine”, “imported special health service medicine”, “made special health service medicine” and listing of a presentation of special health service medicine in a Drug Tariff
s.015 Categories of purchaser
s.021 Information to be recorded and kept about supply of listed health service appliances: medical supplies wholesalers
s.029 Requirement to provide information about discontinuation or anticipated supply shortage of certain health service medicines
s.033 Appeals
s.034 Disclosure of information
s.035 Transitional provisions
s.036 Annual review
Schedules

Schedules

0 of 22 shown
22 other schedules
s.sch001 Interpretation: general
s.sch001 Meaning of “presentation of health service medicine”
s.sch001 Meaning of “UK primary medical services provider”, “Health Service chemist” and related expressions
s.sch001 Meaning of “net NHS expenditure”, “net NHS wholesale income”, “net purchase amount” and “net sales income”
s.sch001 Meaning of “NHS framework contract”
s.sch001 Interpretation: listing of an appliance in a Drug Tariff
s.sch002 General
s.sch002 Interpretation of Schedule 2
s.sch002 UK primary medical providers who are small producers
s.sch002 Health Service chemists who are small producers
s.sch002 NHS hospital purchasers who are small producers
s.sch002 Other UK producers who are small producers
s.sch003 Interpretation of Schedule 3
s.sch003 Daily penalty payable by UK producers who are small producers
s.sch003 Daily penalty payable by UK producers who are not small producers
s.sch004 (1) The bodies specified in column 1 of Table 1,...
s.sch004 (1) The bodies specified in column 1 of Table 2...
s.sch005 General
s.sch005 Transitional provision: information about supply of unbranded generic health service medicines
s.sch005 Circumstances in which transitional provision in paragraph 2 ceases to apply
s.sch005 Transitional provision: information about supply of special health service medicines
s.sch005 Circumstances in which transitional provision in paragraph 4 ceases to apply

Duty extraction and severity labels are Guvnor’s analysis of the instrument, not the instrument itself. Always verify against the linked source text.