Therapeutic Goods Regulations (Amendment) (Cth)

Statutory Rules 1992

No. 430 1

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Therapeutic Goods Regulations 2(Amendment)

I, The Governor-General of the Commonwealth of Australia, acting with the advice of the Federal Executive Council, make the following Regulations under the Therapeutic Goods Act 1989.

 Dated 17 December 1992.

 BILL HAYDEN

 Governor-General

 By His Excellency’s Command,

B. HOWE

Minister of State for Health, Housing and

Community Services

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1.   Commencement

1.1   Regulations 4 and 7 commence on 1 January 1993.

[NOTE:

 The remainder of these Regulations commence on gazettal: see Acts Interpretation Act 1901, s. 48.]

2.   Amendment

2.1   The Therapeutic Goods Regulations are amended as set out in these Regulations.

3.   Regulation 3 (State or Territory laws that continue to apply)

3.1   Subregulation 3 (2):

Omit “2 years”, substitute “3 years”.

4.   New Part 2A

4.1   After regulation 9, insert:

“PART2A—PATIENT INFORMATION

Information about certain therapeutic goods to be supplied

 “9A. (1) A person must not supply therapeutic goods that are:

• (a)

  specified in Schedule 10; and

• (b)

  approved for registration on or after 1 January 1993;

unless the person supplies with the goods written information about the goods that meets the requirements for a patient information document set out in Schedule 12.

Penalty: $1,000.

“(2)

For the purposes of subregulation (1), information must be provided:

• (a)

  in the primary pack in which the therapeutic goods are supplied; or

• (b)

  in another manner that will enable the information to be given to a person to whom the goods are administered or otherwise dispensed.”.

5.   New regulations 14A, 14B and 14C

5.1   After regulation 14, insert:

Re-assignment of registration or listing numbers

 “14A. (1) A person in whose name therapeutic goods or grouped therapeutic goods are registered or listed may apply for the therapeutic goods to be assigned a different registration or listing number.

“(2)

An application:

• (a)

  must be made in writing to the Secretary and delivered to an office of the Department; and

• (b)

  must have with it written information in such detail as is reasonably necessary to allow the application to be properly considered; and

• (c)

  may contain a nomination referred to in subparagraph (6) (b) (ii).

“(3)

The Secretary may assign to therapeutic goods that:

• (a)

  were grouped therapeutic goods when a registration or listing number was assigned, or last assigned, to the goods; and

• (b)

  are not grouped therapeutic goods when:

  • (i)

    the application is decided; or

  • (ii)

    an order is made under section 16 of the Act in relation to the goods;

a registration or listing number that is not assigned to other therapeutic goods or grouped therapeutic goods.

“(4)

The Secretary must assign to grouped therapeutic goods that:

• (a)

  were in a gazetted therapeutic devices group or a gazetted therapeutic goods group when a registration or listing number was assigned, or last assigned, to the goods; and

• (b)

  are in a gazetted therapeutic devices group, or a gazetted therapeutic goods group, other than a group referred to in paragraph (a), when:

  • (i)

    the application is decided; or

  • (ii)

    an order is made under section 16 of the Act in relation to the goods;

a registration or listing number that is not assigned to other therapeutic goods or grouped therapeutic goods.

“(5)

The Secretary must assign to therapeutic goods that:

• (a)

  were not grouped therapeutic goods when a registration or listing number was assigned, or last assigned, to the goods; and

   
• (b)

  are grouped therapeutic goods when:

  • (i)

    the application is decided; or

  • (ii)

    an order is made under section 16 of the Act in relation to the goods;

a registration or listing number in accordance with subregulation (6).

“(6)

The Secretary:

• (a)

  may assign to grouped therapeutic goods to which subregulation (5) applies another registration or listing number; and

• (b)

  must assign to those goods a registration or listing number that:

  • (i)

    was assigned, or last assigned, to the goods; and

  • (ii)

    is nominated by the person in whose name the goods are registered or listed;

not being a registration or listing number that is assigned to other therapeutic goods or grouped therapeutic goods.

Correction of registration or listing numbers

 “14B. The Secretary may, on his or her own initiative, amend a registration or listing number of therapeutic goods or grouped therapeutic goods for the purpose of correcting a clerical error or an obvious mistake.

Notice of re-assignment of registration or listing numbers

 “14C. The Secretary must give notice in writing to a person in whose name therapeutic goods or grouped therapeutic goods are registered or listed if a registration or listing number is assigned to the goods under regulation 14A or 14B.”.

6.   Regulation 48 (Review of decisions)

6.1   Subregulation 48 (1) (definition of “initial decision”):

Omit the definition, substitute:

“ ‘initial decision’ means a decision of the Secretary under regulation 7 or 9, subregulation 13 (7), subregulation 14A (3), (4), (5) or (6), subregulation 22 (8) or regulation 45;”.

 

7.   New Schedule 12:

7.1   Add at the end:

SCHEDULE 12 Subregulation 9A (1)

 

PATIENT INFORMATION DOCUMENTS

 

A patient information document about a medicinal product must be:

 . written in English

 . clearly legible

. written in language that will easily be understood by patients

 . consistent with product information (within the meaning of section   32 of the Act) about the product.

A patient information document must include the following:

1.   Identification

The name of the medicinal product, which is the name given to the product by the sponsor, including or followed by the non-proprietary name(s) of the active ingredient(s) and the dosage form or strength, or both, of the product.

A statement of the active ingredients expressed quantitatively and excipients expressed qualitatively, using their common names, in the case of each presentation of the product.

The pharmaceutical form and the contents by weight, volume or number of doses of the product, in the case of each presentation of the product, together with its identifying Australian Register number.

 

2. What the product

is used for and howit works

 

The therapeutic indications, unless a competent authority determines that dissemination of such information may have serious disadvantages for the patient.

The pharmaco-therapeutic group, or type of activity, if there is a term that is easily comprehensible for the patient.

 If not, a simple description of what the medicinal product is for and how it works, in 1 or 2 sentences.

 

SCHEDULE 12—continued

 

3.   Advice before using themedicinal product

 

A list of factors that are useful to consider before taking the medicinal product, including, if appropriate:

 

 . contraindications, including consideration of whether the patient has experienced previous allergic reactions

 

 . precautions for use, taking into account the particular condition of certain categories of users, such as the elderly, children, infants, pregnant or breastfeeding women, persons with specific pathological conditions

 

 . potential effects of the medicinal product on the ability to drive vehicles or to operate machinery

 

 . interactions with other medicinal products or other forms of interaction (for example with alcohol, tobacco, foodstuffs) which may affect the action of the product

 

 . special warnings, such as effects on sensitivity to sun exposure.

 

4.   How to use the medicinalproduct properly

 

The necessary and usual instructions for proper use of the medicinal product, in particular:

 

 . the dosage, together with an indication that this may not always apply and may be modified by the prescriber

 

 . the method and, if necessary, route of administration

 

 . the frequency of administration, specifying, if necessary, the appropriate time at which the medicinal product should or must be used

 

SCHEDULE 12—continued

In addition, depending upon the nature of the therapeutic goods:

 

 . the duration of treatment, if it should be limited

 

 . the expected effect of using the medicinal product

 

 . what to do if 1 or more doses have not been taken

 

 . the way the treatment should be stopped, if stopping the treatment may lead to withdrawal or other adverse effects.

 

5.   Further information

 

For example, habit forming potential, whether a doctor’s prescription is required.

 

6.   Unwanted effects

 

A description of the undesirable effects that can occur under normal use of the medicinal product and, if necessary, the action to be taken if experienced.

The patient should be expressly invited to communicate any undesirable effect, especially if it is not mentioned in the patient information document, to his or her doctor or pharmacist.

 

7.   In case of overdose

 

The action to be undertaken in the case of overdose (for example, symptoms

 and emergency procedures).

 

8.   Storage conditions

 

An indication of the appropriate storage conditions; a reference to the expiry date indicated on the label, with a warning against using the medicinal product after this date; if appropriate, a warning against visible signs of deterioration.

SCHEDULE 12—continued

 

9.   Where to go for further information

 

A direction to patients to discuss any aspect with the doctor or pharmacist and, if appropriate, where further information may be obtained.

 

10.   Sponsor

 

The name and address of the Australian sponsor of the medicinal product.

 

11.   Date of information

 

The date on which the patient information document was last revised.

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Note 1: “Common name” is the international non-proprietary name recommended by WHO or, if one does not exist, the usual common name.

 

Note 2: The information need not appear in the order outlined above. For example, the subsidiary information under “Identification” could appear at the end of the patient information document.

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NOTES

1. Notified in the Commonwealth of Australia Gazette on 24 December 1992.

2. Statutory Rules 1990 No. 394 as amended by 1991 Nos. 84 and 485; 1992 Nos. 19, 89, 109, 332 and 370.