UK Statutory Instrument SI 2018/345 United Kingdom

The Branded Health Service Medicines (Costs) Regulations 2018

Read it on legislation.gov.uk (opens in a new tab)
Status
In Force
Penalty ceiling
Prosecution 2 of 25 obligations carry a criminal penalty. 1 carries different penalties and 22 have no criminal penalty — flagged in the list below.

Does it bind you?

Business-side roles with duties under this instrument.

Manufacturer25

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

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.003 Payment scheme Regulated
  • Pay a percentage of net sales income from branded health service medicines to the Secretary of StateManufacturer
s.003 Older presentation additional payments Regulated
  • Pay additional payments on older presentations if price declines below reference priceManufacturer
s.003 Reference prices for older presentations Regulated
  • Request a reference price for older presentations of branded health service medicinesManufacturer
s.006 Penalties Regulated
  • Fail to pay branded health service medicines costs on timeManufacturer
s.009 New presentation Regulated
  • Notify the Secretary of State before launching a new presentationManufacturer
s.011 Increases Regulated
  • Keep records for 6 years if you intend to apply for a price increaseManufacturer
s.012 Decreases Regulated
  • Keep records for 6 years if you intend to apply for a price decreaseManufacturer
s.016 Penalties Prosecution
  • Exceed maximum medicine price or breach pricing requirementsManufacturer

Fine up to £100,000

s.018 Provision of information for payment scheme Regulated
  • Record and provide payment scheme information to the Secretary of StateManufacturer
s.021 Sales report Regulated
  • Submit detailed sales reports via the NHS BSA online gatewayManufacturer
s.022 Presentation report Regulated
  • Submit a presentation report via the NHS BSA gateway with detailed sales dataManufacturer
s.023 Audited information Regulated
  • Provide audited sales and presentation reports with required auditor documentsManufacturer
s.024 Written declaration of approval Regulated
  • Include written declaration of approval when providing informationManufacturer
s.026 Penalties, demands and appeals Regulated
  • Fail to comply with medicines reporting or information requirementsManufacturer
19 other provisions — procedural and definitional
s.001 Citation, commencement and interpretation
s.002 Application
s.003 Meaning of newer presentation and older presentation
s.003 Determination of reference prices
s.004 Direction to make a payment
s.005 Interest payable on late payment
s.007 Demands and appeals
s.008 Maximum price
s.010 Temporary exemptions
s.013 Former voluntary scheme members
s.014 Recoverable sum
s.015 Interest payable on late payment of the recoverable sum
s.017 Demands and appeals
s.019 New manufacturer or supplier
s.020 Small manufacturer or supplier
s.025 Review
s.027 Appeals
s.028 Revocation, saving and transitional provisions
s.029 Annual review
Schedules

Schedules

11 of 34 shown
s.sch001 Payment scheme requirements Regulated
  • Pay branded health service medicine costs as requiredManufacturer
s.sch001 Any payment required to be made under regulation 3(1AA) by... Regulated
  • Pay annual branded health service medicine payments by electronic transferManufacturer
s.sch001 Where the requirement to make a payment set out in... Regulated
  • Provide sales reports and audited reports when payment requirement starts mid-periodManufacturer
s.sch001 Where the requirement to make a payment set out in... Regulated
  • Provide sales reports and calculate payments when payment obligation ends mid-periodManufacturer
s.sch001 Where a manufacturer or supplier changes the length of their... Regulated
  • Notify the Secretary of State of any change to your accounting reference periodManufacturer
s.sch001 A manufacturer or supplier whose financial year does not end... Regulated
  • Submit split audited sales reports if your financial year doesn't end on 31st DecemberManufacturer
s.sch001 A manufacturer or supplier must provide two or more separate... Regulated
  • Submit separate sales reports when payment percentages changeManufacturer
s.sch002 Information requirements Regulated
  • Report net sales income to the Secretary of State if below thresholdManufacturer
s.sch002 A manufacturer or supplier referred to in paragraph 3 must... Regulated
  • Report total net sales income within 30 days of each financial yearManufacturer
s.sch003 Where the requirement to make a payment set out in... Regulated
  • Calculate and report payments when you first become liable part-way through a periodManufacturer
s.sch003 Where the requirement to make a payment set out in... Regulated
  • Submit adjusted sales reports and payment if your payment obligation ends mid-periodManufacturer
23 other schedules
s.sch001 Information requirements
s.sch001 Rules
s.sch001 A manufacturer's or supplier's “previous accounting reference period” means the...
s.sch002 Determination of small manufacturer or supplier
s.sch002 The manufacturer or supplier referred to in paragraph 1(a) is...
s.sch002 The manufacturer or supplier referred to in paragraph 1(b) is...
s.sch002 Rules
s.sch002 The end date of the final period in the manufacturer's...
s.sch002 Where a manufacturer or supplier changes the length of their...
s.sch002 A manufacturer's or supplier's “previous accounting reference period” means the...
s.sch003 Information requirements
s.sch003 Where the new manufacturer or supplier is not a small...
s.sch003 Rules
s.sch003 The end date of the final period in a manufacturer's...
s.sch003 Where a manufacturer or supplier changes the length of their...
s.sch003 A manufacturer's or supplier's “previous accounting reference period” means the...
s.sch004 For the purposes of regulation 14, the recoverable sum will...
s.sch004 In respect of a contravention described in column (1) of...
s.sch004 For the purposes of this Schedule— (a) “second contravention” occurs...
s.sch005 Subject to paragraph 2, the daily penalty payable by a...
s.sch005 Where the Secretary of State is unable to reasonably determine...
s.sch005 Subject to paragraph 4, for the purposes of table 2,...
s.sch005 For the purposes of table 2, the Total United Kingdom...

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