COMMONWEALTH OF AUSTRALIA
Department of Health
Therapeutic Goods Administration
THERAPEUTIC GOODS ACT 1989
Section 14 and 14A Notice
On 16 June 2015, 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”), on the application of, Pfizer Australia Pty Ltd gave consent to the importation and supply of:
- sildenafil (as citrate) (VIAGRA) 25 mg tablet blister pack [AUST R 64434]
- sildenafil (as citrate) (VIAGRA) 50 mg tablet blister pack [AUST R 64435]
- sildenafil (as citrate) (VIAGRA) 100 mg tablet blister pack [AUST R 64436]
that does not conform with the requirements of paragraph 3(2)(h) and 3(2)(i) of the Therapeutic Goods Order No. 69 – General requirements for labels for medicines, in that the batch number and expiry date prefixes are not printed on the foil blister labels.
The consent is effective from 16 June 2015 until 31 October 2015.
The delegate of the Secretary, under subsection 15(1) of the Act, made the consent subject to the following conditions:
- The foil blister labels to which this consent applies are those currently approved, which do not bear the batch number and expiry date prefixes;
- A ‘Dear Pharmacist’ letter identical to that provided to the Therapeutic Goods Administration on 16 June 2015 (TGA ref: R15/480132), advising them to remind patients to keep the blister packs with the correctly labelled carton, must be provided with each of the affected batches.
- No other changes have been made to this product.