UK Statutory Instrument
2018
United Kingdom
The Health Service Products (Provision and Disclosure of Information) Regulations 2018
At a glance
What's here
21 compliance obligations
What this Act requires
Sections that create concrete duties on businesses or carry penalties. Procedural and definitional sections are folded into the “Browse other sections” expander at the bottom of each group. Click any section title to read the source text on legislation.gov.uk.
Schedules
Browse 22 other Schedules — structural / supplementary
Meaning of “presentation of health service medicine”
Meaning of “UK primary medical services provider”, “Health Service chemist” and related expressions
Meaning of “net NHS expenditure”, “net NHS wholesale income”, “net purchase amount” and “net sales income”
Meaning of “NHS framework contract”
Interpretation: listing of an appliance in a Drug Tariff
General
Interpretation of Schedule 2
UK primary medical providers who are small producers
Health Service chemists who are small producers
NHS hospital purchasers who are small producers
Other UK producers who are small producers
Interpretation of Schedule 3
Daily penalty payable by UK producers who are small producers
Daily penalty payable by UK producers who are not small producers
(1) The bodies specified in column 1 of Table 1,...
(1) The bodies specified in column 1 of Table 2...
General
Transitional provision: information about supply of unbranded generic health service medicines
Circumstances in which transitional provision in paragraph 2 ceases to apply
Transitional provision: information about supply of special health service medicines
Circumstances in which transitional provision in paragraph 4 ceases to apply
Information to be recorded and kept about supply of unbranded generic health service medicines: manufacturers and importers
- Record and keep supply information for unbranded generic health service medicines
Information to be recorded and kept about supply of unbranded generic health service medicines: medicines wholesalers
- Record and keep information on unbranded generic medicine purchases and supplies
Requirement to provide information about supply of unbranded generic health service medicines
- Provide quarterly information about unbranded generic health service medicines
Information to be recorded about supply of made special health service medicines: manufacturers
- Record supply information for made special health service medicines
Information to be recorded about supply of made special health service medicines: medicines wholesalers
- Record purchase and supply details of made special health service medicines
Information to be recorded and kept about supply of imported special health service medicines: medicines wholesalers and importers
- Record and keep purchase and supply information for imported special health service medicines
Requirement to provide information about the supply of special health service medicines
- Provide quarterly information on supply of special health service medicines
Information to be recorded and kept about supply of imported special health service medicines: medicines wholesalers and importers
- Record and keep information about purchases and supplies of imported special health service medicines
Information to be recorded and kept about supply of health service medicines other than imported special health service medicines: medicines wholesalers
- Record and keep purchase and supply information for health service medicines (wholesalers)
Information to be recorded and kept about supply of health service medicines other than imported special health service medicines: other UK producers
- Record and keep supply details for health service medicines
Information to be recorded and kept about supply of health service medicines to patients otherwise than by sale
- Record and keep purchase information for health service medicines supplied to patients
Information to be recorded and kept about supply of health service appliances: manufacturers and importers
- Record and keep supply details for health service appliances
Information to be recorded and kept about supply of appliances, food and dermatological products to patients otherwise than by sale
- Record and keep supply information for certain health products provided free to patients
Provision of information recorded and kept under this Part to the Secretary of State
- Provide retained information to the Secretary of State when requested
Provision of information: small producers
- Provide net NHS sales income when requested as a specific small producer
Provision of information about costs incurred in connection with the manufacture or distribution of a particular health service medicine or appliance
- Provide cost information to the Secretary of State when requested
Provision of general information about costs incurred in connection with the manufacture or distribution of health service medicines and appliances
- Provide cost information requested by the Secretary of State
Provision of information about English health service medicines which are not available at the reimbursement price
- Provide requested information on medicine availability and pricing within 2 working days
Provision of information about availability of health service medicines
- Provide information on medicine availability when requested by the Secretary of State
Requirement to provide information about reasonable estimates
- Provide reasons and method when using reasonable estimates
Compliance procedure
- Comply with a compliance notice issued by the Secretary of State
Browse 15 other sections — procedural / definitional / commencement
Citation and commencement
Interpretation: general
Application
Exception: products not known to be health service products
Information required to be provided via an NHS England online gateway
Meaning of “unbranded generic health service medicine” and listing of a presentation of unbranded generic health service medicine
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
Categories of purchaser
Information to be recorded and kept about supply of listed health service appliances: medical supplies wholesalers
Requirement to provide information about discontinuation or anticipated supply shortage of certain health service medicines
Penalties
Appeals
Disclosure of information
Transitional provisions
Annual review
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