Consent given pursuant to sections 14 and 14A for the importation and supply of the therapeutic goods specified - BGP Products Pty Ltd

Administered by Department of Health, Disability and Ageing

Legislation au C2015G00291 In force Gazette

Legislation content

COMMONWEALTH OF AUSTRALIA

Department of Health
Therapeutic Goods Administration

THERAPEUTIC GOODS ACT 1989

Section 14 and 14A Notice

 

 

On 11 February 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 BGP Products Pty Ltd, gave consent to the importation and supply of:

  • please see complete list of products below, that do not conform with the requirements of paragraph 3(2)(l) of the Therapeutic Goods Order No. 69 – General requirements for labels for medicines, in that the labels bear the previous sponsor details.

The consent is effective from the date of this letter until 11 February 2017.

The delegate of the Secretary, under subsection 15(1) of the Act, made the consent subject to the following conditions:

  1. The labels to which this consent applies are those currently approved.
  2. Arrangements are in place that any correspondence concerning the products will be promptly referred from the former sponsor (Abbott Australasia Pty Ltd) to the current sponsor (BGP Products Pty Ltd).
  3. No other changes have been made to the products.

 

 

 

 

 

 

 

 

 

 

 

List of Products

No

AUST R

Product

1

54033

verapamil hydrochloride (CORDILOX 180 SR) 180 mg tablet blister pack

2

10681

verapamil hydrochloride (CORDILOX SR) 240 mg tablet blister pack

3

54032

verapamil hydrochloride (ISOPTIN 180 SR)180 mg tablet blister pack

4

12801

verapamil hydrochloride (ISOPTIN SR) 240 mg tablet blister pack

5

12796

verapamil hydrochloride (ISOPTIN) 5 mg/2 mL injection ampoule

6

65502

verapamil hydrochloride (ISOPTIN) 40 mg tablet blister pack

7

65503

verapamil hydrochloride (ISOPTIN) 80 mg tablet blister pack

8

65504

verapamil hydrochloride (ISOPTIN) 160 mg tablet blister pack

9

65505

verapamil hydrochloride (ISOPTIN) 120 mg tablet blister pack

10

13295

lactulose (DUPHALAC) 667 mg/mL oral liquid bottle

11

45455

trandola pril (GOPTEN) l mg capsules blister pack

12

45456

trandola pril (GOPTEN) 0.5 mg capsule blister pack

13

45457

trandolapril (GOPTEN) 2 mg capsules blister pack

14

96969

trandolapril (GOPTEN) 4 mg capsule blister pack

15

50682

clarithromycin (KLACID) 500 mg tablet bottle

16

52473

clarithromycin (KLACID) 500 mg tablet blister pack

17

56729

clarithromycin (KLACID) 250 mg/5 mL powder for oral liquid bottle

18

57632

fluvoxamine maleate (LUVOX) 50 mg tablet blister pack

19

57633

fluvoxamine maleate (LUVOX) 100 mg tablet blister pack

20

59522

dried ferrous sulfate (FERRO-GRADUMET) 325 mg tablet bottle

21

61687

betahistine dihydrochloride (SERC) 16 mg tablet blister pack

22

64400

eprosartan (as mesylate) (TEVETEN) 400 mg tablet blister pack

23

73779

eprosartan (as mesylate) (TEVETEN) 600 mg tablet blister pack

24

66841

FERROGRAD C tablet bottle

25

75888

oestradiol (as hemihydrate) ZUMENON 2 mg tablet blister pack

26

77937

FGF tablet bottle (reformulation 2)

27

219882

oestradiol (FEMOSTON) 1/10 l mg and oestradiol l mg with dydrogesterone 10 mg tablet blister pack composite pack

28

75889

oestradiol (FEMOSTON) 2/10 2 mg and oestradiol 2 mg with dydrogesterone 10 mg tablet blister pack composite pack

29

78654

FEMOSTON-CONTI tablet blister pack

30

79335

mebeverine hydrochloride (COLOFAC) 135 mg tablet blister pack

31

79564

clarithromycin (KLACID) 250 mg tablet blister pack

32

79576

clarithromycin (KLACID) 250 mg tablet bottle

33

80659

ibuprofen (BRUFEN) 400 mg tablet blister pack

34

104663

trandolapril (TARKA 2/180) 2 mg & verapamil hydrochloride 180 mg tablet blister pack

35

104664

trandolapril (TARKA 4/240) 4 mg & verapamil hydrochloride 240 mg tablet blister pack

36

114119

moxonidine (PHYSIOTENS) 200 microgram tablet blister pack

37

114121

moxonidine (PHYSIOTENS) 400 microgram tablet blister pack

38

114122

moxonidine (NORMATENS) 200 microgram tablet blister pack

39

114124

moxonidine (NORMATENS) 400 microgram tablet blister pack

40

118634

fenofibrate (LIPIDIL) 145 mg tablet blister

 

 

 

 

 

 

 

 

No

AUST R

Product

41

118642

fenofibrate (LIPIDIL) 48 mg tablet blister

42

120955

lercanidipine hydrochloride (ZAN-EXTRA 10/10) 10 mg and enalapril maleate 10 mg film coated tablets blister pack

43

120961

lercanidipine hydrochloride (ZAN-EXTRA 10/20) 10 mg and enalapril maleate 20 mg film coated tablets blister pack

44

121315

terazosin 1 mg (as hydrochloride dihydrate) (HYTRIN) and terazosin 2 mg (as hydrochloride dihydrate) (HYTRIN) tablet blister pack composite pack

45

121316

terazosin (as hydrochloride dehydrate) (HYTRIN) 1 mg tablet blister pack

46

121317

terazosin (as hydrochloride dehydrate) (HYTRIN) 2 mg tablet blister pack

47

121318

terazosin (as hydrochloride dehydrate) (HYTRIN) 5 mg tablet blister pack

48

121319

terazosin (as hydrochloride dehydrate) (HYTRIN) 10 mg tablet blister pack

49

143172

eprosartan (TEVETEN PLUS 600/12.5) 600 mg hydrochlorothiazide 12.5 mg tablet blister

50

77506

lercanidipine hydrochloride (ZANIDIP) 10 mg film coated tablet blister pack

51

93733

lercanidipine hydrochloride (ZANIDIP) 20 mg film coated tablet blister pack

52

152707

lercanidipine (LERCAN) hydrochloride l0 mg tablet blister pack

53

152708

lercanidipine (LERCAN) hydrochloride 20 mg tablet blister pack

54

152709

lercanidipine hydrochloride (LERCADIP) 10 mg tablet blister pack

55

152710

lercanidipine hydrochloride (LERCADIP) 20 mg tablet blister pack

56

165899

lercanidipine hydrochloride (ZANICAN) 10 mg film coated tablet blister pack

57

165900

lercanidipine hydrochloride (ZANICAN) 20 mg film coated tablet blister pack

58

165913

lercanidipine hydrochloride (LERCANIDIPINE SANDOZ) 10 mg film coated tablet blister pack

59

165914

lercanidipine hydrochloride (LERCANIDIPINE SANDOZ) 20 mg film coated tablet blister pack

60

155717

omega-3-acid ethyl esters 90 (OMACOR) 1000 mg soft capsule bottle

61

158451

pancreatic extract (CREON 40,000) 400 mg capsules of enteric-coated minimicropsheres bottle

62

158452

pancreatic extract (CREON 25,000) 300mg capsule bottle

63

158453

CREON 10,000 capsule bottle (reformulation)

64

166118

pancreatic extract (CREON MICRO) 20 g enteric coated granules bottle

65

215555

inactivated influenza ( INFLUVAC) 0.5 mL vaccine long syringe with 16 mm needle

66

81465

inactivated influenza (INFLUVAC) 0.5 mL vaccine syringe

 

Overview

The Therapeutic Goods Act 1989 (the Act) was enacted to regulate the supply and importation of therapeutic goods in Australia, ensuring their safety, quality, and efficacy. The Act was introduced to address the need for a comprehensive regulatory framework governing therapeutic goods, including medicines, medical devices, and blood and blood components. Enacted by the Parliament of Australia, the policy objective of the Act is to protect public health by ensuring that therapeutic goods available in Australia meet appropriate standards of quality, safety, and efficacy. In this context, the Therapeutic Goods Administration (TGA) operates under the Department of Health to administer and enforce the provisions of the Act. Recently, on 11 February 2015, the delegate of the Secretary of the Department of Health provided consent for the importation and supply of certain products that do not conform with specific labelling requirements, subject to certain conditions to ensure patient safety and proper product management.

Scope and Application

The Therapeutic Goods Act 1989, administered by the Therapeutic Goods Administration (TGA) under the Commonwealth of Australia's Department of Health, governs the regulation of therapeutic goods in Australia. This legislation applies to a broad spectrum of entities, including individuals, companies, and other organisations involved in the importation, manufacture, supply, advertising, or sponsorship of therapeutic goods. These goods encompass a wide range of products such as medicines, medical devices, blood, and tissues, ensuring that they meet safety, quality, and efficacy standards. The Act has a nationwide jurisdictional reach, extending its regulatory authority across the entire Commonwealth of Australia. The consent granted under sections 14 and 14A of the Act, in this case concerning BGP Products Pty Ltd, allows for the temporary importation and supply of specified products that do not conform to certain labelling requirements, provided that certain conditions are met. The consent is effective until 11 February 2017 and is subject to conditions such as maintaining current approved labels and ensuring that any correspondence concerning the products is promptly referred from the former sponsor to the current sponsor. The application of the Act can be further extended or restricted through subordinate instruments, which may include regulations and orders, thereby providing flexibility and specificity in its implementation.

Key Provisions

The Therapeutic Goods Act 1989 (the Act) contains various provisions that regulate the importation and supply of therapeutic goods in Australia. Section 14 of the Act allows the delegate of the Secretary of the Department of Health to give consent for the importation and supply of therapeutic goods that do not conform to certain requirements, such as labelling. In this case, Section 14A Notice, issued on 11 February 2015, provides consent for BGP Products Pty Ltd to import and supply a list of products that do not conform to the requirements of paragraph 3(2)(l) of the Therapeutic Goods Order No. 69 – General requirements for labels for medicines. This consent is effective from the date of the letter until 11 February 2017. The consent given under Section 14 of the Act is subject to specific conditions, outlined in Section 15(1) of the Act. Firstly, the labels to which this consent applies are those currently approved. Secondly, there must be arrangements in place to promptly refer any correspondence concerning the products from the former sponsor (Abbott Australasia Pty Ltd) to the current sponsor (BGP Products Pty Ltd). Lastly, no other changes have been made to the products. Entities governed by the Act, such as BGP Products Pty Ltd, have obligations to comply with the consent conditions and any other applicable regulations. This includes ensuring that the labels used for the products are those currently approved and that correspondence is properly referred from the former sponsor to the current sponsor. Failure to comply with the conditions of the consent or any other requirements of the Act may result in offences, penalties, or civil/criminal consequences. The specific penalties for breaches of the Act are not detailed in the provided text, but they could include fines or imprisonment, depending on the nature and severity of the breach.

Legal classification tags

Area of Law
Regulatory Standards
Instrument
Gazette Notice
Concepts
Regulatory Standards
Reporting & Disclosure Obligations
Compliance Obligations
Catchwords
Consent for importation and supply

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Sourced from the Federal Register of Legislation at 26 August 2026. For the latest information on Australian Government law please go to https://www.legislation.gov.au.