Amendments Nos. 12 to 15, inclusive, are consequential on amendment No. 11 and all may be discussed together.
SECTION 31.
I move amendment No. 11:
In page 18, subsection (2), line 15, after "may" to insert ", in relation to medicinal products for human use or cosmetic products,".
There are a series of amendments to section 31 (2) which are interrelated. During the discussions on the Bill with industry representatives it was suggested that, as originally drafted, it was not clear that all the provisions of subsection (2) related only to medicinal preparations for human use and cosmetic products, as was the intention. In view of the concerns expressed I referred the matter to the parliamentary draftsman and it was decided the subsection would benefit from being amended along the lines now proposed.
Section 31 (2) is essentially intended to replace section 65 of the Health Act, 1947, which will be repealed. This provides the Minister with the powers to make regulations regarding the licensing of medicinal preparations for human use and cosmetic products. The regulations will set out, similar to the existing regulations under section 65, the essential requirements and features of the licensing process.
It was not clear that the term "medicinal products for human use or cosmetic products" referred to all the sections because it was not specifically mentioned in some of them. The insertion of the phrase before subsection (2) makes it clear that it refers to all the sections. We are deleting the phrase from the sections in which it was already included. The purpose of the amendment is to make it absolutely clear that this relates to human health and cosmetics. That is the sole intention of this change.
The Minister will make regulations arising from this amendment. There was a reference earlier to a possible appeal system. Obviously there is no necessity for regulations on the veterinary side because they are already covered.
They are covered under the Animal Remedies Act.
Any appeal system the Minister might consider would apply only to human medicines.
That is my thinking and obviously the Department of Agriculture has a role in relation to the veterinary side.
Amendment agreed to.
I move amendment No. 12:
In page 18, subsection (2) (a), lines 19 and 20, to delete "medicinal products for human use or cosmetic products" and substitute "the product or products to which the regulations relate".
Amendment agreed to.
I move amendment No. 13:
In page 19, subsection (2) (h), lines 2 and 3, to delete "medicinal product for human use" and substitute "product or products".
Amendment agreed to.
I move amendment No. 14:
In page 19, subsection (2) (j), lines 17 and 18, to delete "medicinal products for human use and cosmetic products" and substitute "the product or products to which the regulations relate".
Amendment agreed to.
I move amendment No. 15:
In page 19, subsection (2) (k), lines 23 and 24, to delete "medicinal products for human use and cosmetic products" and substitute "the product or products to which the regulations relate".
Amendment agreed to.
Section 31, as amended, agreed to.
Section 32 agreed to.