Blackmores - Lyprinol and Lyprinol Double

Therapeutic Goods Act 1989

Approval under section 42DF for use of restricted representations by Blackmores Ltd

I, Jane Cook, Head, Pharmacovigilance and Special Product Access Branch, Therapeutic Goods Administration and delegate of the Secretary to the Department of Health, on receipt of an application from Blackmores Ltd, have approved under section 42DF of the Therapeutic Goods Act 1989 (the Act) the restricted representations described in paragraphs (a, (b) and (c) below for use in advertisements directed to consumers, for the products identified in paragraph (d), provided the condition identified in paragraphs (e) and (f) are met:

1. Representations that refer to "arthritis", "osteoarthritis" and "rheumatoid arthritis" to the effect of providing accurate, balanced and contemporary information, the purpose of which is to inform consumers that there are different types of arthritis and to describe their key features.
2. Representations that refer to "arthritis" and "osteoarthritis" to the effect that the products identified in paragraph (d):
   • May provide symptomatic relief of arthritis/osteoarthritis
3. Representations that refer to "osteoarthritis" to the effect that the products identified in paragraph (d):
   • May provide relief of osteoarthritic pain
4. Blackmores Lyprinol (AUSTL 124441) and
   Blackmores Lyprinol Double (AUSTL 208729)
5. Information about the different types of arthritis must merely distinguish the types of arthritis and their key features. This must be both the purpose of the information and its likely consequence. That is, any information about the different types of arthritis must in no way state or imply that the medicines being advertised are being promoted for any condition other than osteoarthritis.
6. (f) Where representations referring to "arthritis" are used in the context identified in paragraph (b) such references must be qualified as "osteoarthritis".

Dated this 9 day of September 2015

Jane Cook
Delegate of the Secretary to the Department of Health; and
Head
Pharmacovigilance and Special Product Access Branch