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Definitions for Generic Products

Before making a submission to the Scottish Medicines Consortium (SMC), the Marketing Authorisation Holder should initially consult the Guidance to Manufacturers on Submission Criteria. Additional guidance is provided in this document on whether a generic product falls within the remit of the SMC.
 
Generic medicine: a pharmaceutical product for which a marketing authorisation has been granted, for which there is not a brand name but which is identified by the recommended International Non-proprietary Name (rINN) or British Approved Name (BAN) or list of similar standing. The majority of generic medicines are included in Part 7 of the Scottish Drug Tariff (see below).
 
Branded generic medicine: a pharmaceutical product for which a marketing authorisation has been granted and which is the generic bioequivalent of an original patented reference product for which the patent has expired. As well as being identified by the recommended International Non-proprietary Name (rINN) or British Approved Name (BAN), branded generics have a specific trade name and are protected by ®.
 
A branded generic medicine (or combination preparation) is considered to be within SMC remit:
 
  • if an equivalent generic product (or combination product) is not listed, or anticipated not to be listed*, in Part 7 of the Scottish Drug Tariff
 
A branded generic medicine (or combination preparation) is considered to be outwith SMC remit:
 
  • if an equivalent generic product (or combination product) is listed, or anticipated to be listed, in Part 7* of the Scottish Drug Tariff
or
  • if an equivalent branded generic product (or combination product) is available and the new product costs the same or less
*advice on likely entry to the Tariff will be sought by SMC from the Information Services Division (ISD) of National Services Scotland (NSS).
Background information to the categories in Part 7 and inclusion criteria for the Scottish Drug Tariff
 
Definitions for the four price categories included in Part 7.
 
The prices are cascaded in the following order through categories M, A, B and P. Part 7 prices are the agreed prices that will be paid.
 
Category M contains readily available drugs where the reimbursement price is calculated by the Department of Health using information submitted by manufacturers.
 
Category A contains readily available drugs where a weighted average price is calculated from the list prices published by a number of manufacturers and wholesalers.
 
Category B contains products where usage has declined over time and the price is based on that published by Unichem, failing that AAH, failing that Thornton & Ross.
 
Category P contains products where the price is based on that of a particular product
Category R applies to a sub set of drugs/preparations where special reimbursement price setting arrangements are appropriate.
 
Additional criteria on inclusion criteria for Part 7
  1. The product must be capable of being prescribed and dispensed by non-proprietary title with no clinical issues
  2. The product must be available from a number of suppliers in a common pack
  3. The product must be freely available (defined as being in stock at AAH and Alliance)
  4. The product should be available in unbranded versions
 
There is also an uptake threshold, such that products with less than c5000 issues per year are considered too small to be viable.
 
February 2011

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