UK Statutory Instrument 2018 United Kingdom

The Branded Health Service Medicines (Costs) Regulations 2018

At a glance

What's here

22 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

s.sch001

Payment scheme requirements

  • Pay branded health service medicine costs as required
s.sch001

Any payment required to be made under regulation 3(1AA) by...

  • Pay annual branded health service medicine payments by electronic transfer
s.sch001

Where the requirement to make a payment set out in...

  • Provide sales reports and audited reports when payment requirement starts mid-period
s.sch001

Where the requirement to make a payment set out in...

  • Provide sales reports and calculate payments when payment obligation ends mid-period
s.sch001

Where a manufacturer or supplier changes the length of their...

  • Notify the Secretary of State of any change to your accounting reference period
s.sch001

A manufacturer or supplier whose financial year does not end...

  • Submit split audited sales reports if your financial year doesn't end on 31st December
s.sch001

A manufacturer or supplier must provide two or more separate...

  • Submit separate sales reports when payment percentages change
s.sch002

Information requirements

  • Report net sales income to the Secretary of State if below threshold
s.sch002

A manufacturer or supplier referred to in paragraph 3 must...

  • Report total net sales income within 30 days of each financial year
s.sch003

Where the requirement to make a payment set out in...

  • Calculate and report payments when you first become liable part-way through a period
s.sch003

Where the requirement to make a payment set out in...

  • Submit adjusted sales reports and payment if your payment obligation ends mid-period
Browse 23 other Schedules — structural / supplementary
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...

s.003

Payment scheme

  • Pay a percentage of net sales income from branded health service medicines to the Secretary of State
s.003

Older presentation additional payments

  • Pay additional payments on older presentations if price declines below reference price
s.003

Reference prices for older presentations

  • Request a reference price for older presentations of branded health service medicines
s.009

New presentation

  • Notify the Secretary of State before launching a new presentation
s.011

Increases

  • Keep records for 6 years if you intend to apply for a price increase
s.012

Decreases

  • Keep records for 6 years if you intend to apply for a price decrease
s.018

Provision of information for payment scheme

  • Record and provide payment scheme information to the Secretary of State
s.021

Sales report

  • Submit detailed sales reports via the NHS BSA online gateway
s.022

Presentation report

  • Submit a presentation report via the NHS BSA gateway with detailed sales data
s.023

Audited information

  • Provide audited sales and presentation reports with required auditor documents
s.024

Written declaration of approval

  • Include written declaration of approval when providing information
Browse 22 other sections — procedural / definitional / commencement
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.006

Penalties

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.016

Penalties

s.017

Demands and appeals

s.019

New manufacturer or supplier

s.020

Small manufacturer or supplier

s.025

Review

s.026

Penalties, demands and appeals

s.027

Appeals

s.028

Revocation, saving and transitional provisions

s.029

Annual review

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