COMMONWEALTH OF AUSTRALIA
Department of Health
Therapeutic Goods Administration
THERAPEUTIC GOODS ACT 1989
Section 14 and 14A Notice
On July 28, 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 Alphapharm Pty Limited gave consent to:
the importation and supply, of
- sildenafil (as citrate) (VEDAFIL) 50 mg film-coated tablet blister pack [AUST R 162805]
- sildenafil (as citrate) (VEDAFIL) 25 mg film-coated tablet blister pack [AUST R 162807]
that does not conform with the requirements of the paragraph 3(13)(a) of the Therapeutic Goods Order No. 69- General requirements for labels for medicines in that the foil label does not contain the name or registered trade mark of the sponsor or supplier of the goods.
The consent applies to batches:
sildenafil (as citrate) (VEDAFIL) 25 mg film-coated tablet blister pack [AUST R 162807]
- Batch 8012563, expiry date February 2016, up to 7000 packs; and
- Batch 8016229, expiry date July 2016, up to 6500 packs
sildenafil (as citrate) (VEDAFIL) 50 mg film-coated tablet blister pack [AUST R 162805]
- Batch 8016228, expiry date July 2016, up to 8600 packs.
The delegate of the Secretary has, under subsection 15(1) of the Act, made the consent subject to the following conditions:
- The Dear Pharmacist letter dated July 23, 2014, supplied to the TGA with your email of July 28, 2014, which sets out the circumstances behind this consent to supply and reminds patients to keep the blister platforms in the outer carton until immediately before taking a dose, will be supplied with the batches of product affected by this consent.