The Government is proposing new regulations that will require manufacturers, wholesalers and pharmacies to provide it with information about the products they supply and the costs of doing business.

The information will be used to determine ‘fair’ reimbursement prices for generics and specials, and help ensure the availability and value-for-money of medicines, says the Department of Health.

The draft regulations give the Government the power to control the price of medicines in certain circumstances, and will provide the DH with a stronger legal basis for enforcing the provision of information in areas like the pharmacy margins survey.

The proposals, which extend existing voluntary schemes, require:

  • Manufacturers, importers and wholesalers to provide quarterly information about sales and purchases of generics and specials products
  • All those involved in the supply chain, including pharmacies, to record, keep and provide on request information related to sales and purchases of medicines, medical supplies and other related products
  • Manufacturers and importers to tell Government about any discontinuation and supply shortages.

A consultation on the draft regulations, made under the Health Service Medical Supplies (Costs) Act 2017, runs until November 14.


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