COMMONWEALTH OF AUSTRALIA
Department of Health
Therapeutic Goods Administration
THERAPEUTIC GOODS ACT 1989
Section 14 and 14A Notice
On 28 May 2014, the delegate of the Secretary of the Department of Health for the purposes of subsection 14 and 14A of the Therapeutic Goods Act 1989 (“the Act”), by application of Merck Sharp & Dohme Australia Pty Ltd, gave consent to:
- the importation and supply of PNEUMOVAX 23 pneumococcal purified capsular polysaccharides 25 microgram/0.5mL injection pre-filled syringe (AUSTR 222235) that does not conform with the requirements of the Therapeutic Goods Order No. 69 - General requirements for labels for medicines in that the syringe labels do not comply with requirements relating to the letter height and inclusion of names of all active ingredients.
The consent is effective from 28 May 2014 until further notice.
The delegate of the Secretary has, under subsection 15(1) of the Act, made the consent subject to the condition that the product must comply with all other applicable parts of Therapeutic Goods Order No. 69 - General requirements for labels for medicines and other applicable standards.