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Feedback on amended Regulation 23  of Therapeutic Products regulations sought

Public consultation will run from 1 March to 31 March.

The Health Sciences Authority (HSA) has invited the public to provide feedback on the proposed changes to Regulation 23 of the Health Products (Therapeutic Products) Regulations.

HSA seeks to facilitate the timely resolution of any potential patent disputes before it grants registration for a therapeutic product.   

Under the proposal, HSA wants Regulation 13 to apply to the following categories of patents that are in force with respect to the therapeutic product undergoing registration application:

  • A patent containing a claim for an active ingredient of that therapeutic product; 
  • A patent containing a claim for a formulation or composition of that therapeutic product; 
  • A patent containing a claim for the use of an active ingredient in the manufacture of that therapeutic product for a specific therapeutic, preventive, palliative or diagnostic use. 

HSA wishes to "provide clarity to industry stakeholders on the types of patents that must be considered when making a registration application for a therapeutic product, and for which the provisions under Regulation 23 apply."

The agency also wants to "ensure a system that facilitates all industry stakeholders in making registration applications and minimise any potential indiscriminate use of the mechanism under regulation 23. 

Interested parties may provide feedback on these amendments until 31 March.

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