Alex White (Dublin South, Labour) | Oireachtas source

I was going to wait and listen to the basis for the Deputy's proposal because it was not entirely clear to me. Schedule 1 sets out procedural provisions relating to certain decisions of the IMB and HSE under the Bill.

Part 1 of the Schedule refers to the procedural provisions relating to the requirement, set out under section 6(1), that the IMB give notice in writing of a relevant decision made under section 5, together with the reasons for the decision to the relevant marketing authorisation holder, MAH. Paragraph 1 of Schedule 1 provides that where the board proposes to makes a relevant decision, it shall give notice in writing of the proposal to each person it would, if the proposal were implemented, be required under section 6(1) to give notice to. As a consequence, the board is obliged to give notice in writing to all authorisation holders of products already included in a group of interchangeable medicinal products of a relevant decision that proposes to change the composition of the group of interchangeable medicinal products. All proposals by the board in this context are therefore material decisions for the purposes of Part I of Schedule 1. It is unclear what would be an immaterial one, they are all material. In those circumstances, I do not propose to accept the amendment.