Therapeutic Goods Regulations 2011

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TherapeuticGoodsRegulations2011




C
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THERAPEUTIC GOODS REGULATIONS
2011



Therapeutic Goods Regulations 2011 Arrangement of Regulations




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C
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THERAPEUTIC GOODS REGULATIONS 2011

Arrangement of Regulations
Regulation

1 Short Title .................................................................................................... 5
2 Interpretation ................................................................................................ 5
3 Import .......................................................................................................... 5
4 Supply other than by wholesale ................................................................. 5
5 Supply by wholesale ................................................................................... 6
6 Manufacture ...................................................................................................... 6
7 Inclusion in registered list ............................................................................ 6
8 Licensed activities ............................................................................................. 6
9 Fees ............................................................................................................. 6
10 Granting and issuance of licence ............................................................... 6
11 Authorised Officers ...................................................................................... 6
12 Exemptions ................................................................................................. 7



SCHEDULE 1 8

FORM 1 8

APPLICATION FOR LICENCE TO IMPORT THERAPEUTIC GOODS 8

FORM 2 9

APPLICATION FOR LICENCE TO SUPPLY MEDICINAL DRUGS (OTHER
THAN BY WHOLESALE) 9

FORM 3 10

APPLICATION FOR LICENCE TO SUPPLY THERAPEUTIC GOODS
(WHOLESALE) 10

FORM 4 11

APPLICATION FOR LICENCE TO MANUFACTURE THERAPEUTIC

Arrangement of Regulations Therapeutic Goods Regulations 2011




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GOODS 11

FORM 5 12

APPLICATION FOR INCLUSION OF MEDICINAL DRUGS IN THE
REGISTERED LIST 12

SCHEDULE 2 13

FEES 13

SCHEDULE 3 14

LICENCE 14



Therapeutic Goods Regulations 2011 Regulation 1




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C
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THERAPEUTIC GOODS REGULATIONS 2011

THERAPEUTIC GOODS ACT 2001

IN EXERCISE of the powers conferred by section 35 of the Therapeutic
Goods Act 2001, the Minister of Health with the consent of Cabinet makes the

following Regulations -

____________________________________________________________________

1 Short Title

These Regulations may be cited as the Therapeutic Goods Regulations 2011.

2 Interpretation

In these Regulations, unless the context otherwise requires –

“Act” means the Therapeutic Goods Act 2001;

“Ministry” means the Ministry of Health; and

“Secretary” means the secretary to the National Drugs and Medical Supplies
Committee established under the Act.

3 Import

An application for a licence to import therapeutic goods shall be –

(a) made in Form 1 of Schedule 1; and

(b) accompanied by the prescribed fees.

4 Supply other than by wholesale

An application for a licence to supply medicinal drugs other than by wholesale shall
be –

Regulation 5 Therapeutic Goods Regulations 2011




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(a) made in Form 2 of Schedule 1; and

(b) accompanied by the prescribed fee.

5 Supply by wholesale

An application for a licence to supply therapeutic goods by wholesale shall be –

(a) made in Form 3 of Schedule 1; and

(b) accompanied by the prescribed fee.

6 Manufacture

An application for a licence to manufacture therapeutic goods shall be –

(a) made in Form 4 of Schedule 1; and

(b) accompanied by the prescribed fee.

7 Inclusion in registered list

An application for inclusion of a medicinal drug in the registered list shall be –

(a) made in Form 5 of Schedule 1; and

(b) accompanied by the prescribed fee.

8 Licensed activities

A licence may authorise one or more of the activities provided in regulations 3, 4, 5,
or 6, provided that the prescribed fee shall be paid for each activity.

9 Fees

For the purposes of the Act and these Regulations the fees shall be those prescribed
in Schedule 2.

10 Granting and issuance of licence

For the purposes of the Act and these Regulations a licence shall be granted and
issued in the form prescribed in Schedule 3, upon payment of the prescribed fee.

11 Authorised Officers

(1) The Secretary shall provide an authorised officer with an identity document
that verifies his designation.

Therapeutic Goods Regulations 2011 Regulation 12




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(2) An authorised officer shall return the identity document to the Secretary
where he is no longer acting as an authorised officer.

12 Exemptions

Pursuant to section 35(c) of the Act, traditional Tongan healers are exempted from
the provisions of the Act and these Regulations, where they supply traditional herbal
materials of local origin that are not processed beyond either drying or simple
extraction and that do not fall into the classes of medicinal drugs in the registered
list.





Made at Nuku’alofa this 8th day of June 2011.


Hon. ‘Uliti Uata
Minister of Health

SCHEDULE 1 Therapeutic Goods Regulations 2011




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SCHEDULE 1

FORM 1

(Regulation 3)

APPLICATION FOR LICENCE TO IMPORT THERAPEUTIC GOODS

Name of applicant:

Applicants Qualification:

Applicant’s business address:

Applicant’s postal address:

Classes of medicinal drugs for which a licence is sought:

(pursuant to section 5(2) of the Act)

Names and addresses of premises at which the therapeutic goods may be stored at any stage,

including point(s) of sale:

Name Address







Declaration:

I declare that the above is a complete list of premis s at which goods subject to import under this

licence may be stored before they are disposed of by this applicant, and that each of these premises

is available for inspection by an authorised officer. Access to any of these premises pursuant to the

Act may be obtained by contacting the person whose signature appears below.

Signature of applicant:

(Where the applicant is a company - a Director or the Secretary)

Signatory’s position in company:

Date of signature:

Contact details for the signatory:

Tel No:

Fax No:

Email:





Therapeutic Goods Regulations 2011 SCHEDULE 1




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FORM 2

(Regulation 4)

APPLICATION FOR LICENCE TO SUPPLY MEDICINAL DRUGS (OTHER
THAN BY WHOLESALE)

Name of applicant:

Applicants Qualification:

Applicant’s business address:

Applicant’s postal address:

Classes of medicinal drugs for which a licence is sought:

(pursuant to section 5(2) of the Act)

Is the applicant a pharmacist, veterinary practitioner or retailer?

(If yes, specify which.)

Names and addresses of premises at which the drugs may be stored at any stage, including the

point(s) of sale by this applicant:

(Attach extra pages if necessary)



Name Address







Declaration:

I declare that the above is a complete list of premis s at which drugs subject to wholesale under this

licence may be stored before they are disposed of by this applicant, and that each of these premises

is available for inspection by an authorised officer. Access to any of these premises pursuant to the

Act may be obtained by contacting the person whose signature appears below.

Signature of applicant:

(Where the applicant is a company - a Director or the Secretary )

Signatory’s position in company:

Date of signature:

Contact details for the signatory:

Tel No:

Fax No:

Email:

SCHEDULE 1 Therapeutic Goods Regulations 2011




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FORM 3

(Regulation 5)

APPLICATION FOR LICENCE TO SUPPLY THERAPEUTIC GOODS
(WHOLESALE)

Name of applicant:

Applicants Qualification:

Applicant’s business address:

Applicant’s postal address:

Classes of therapeutic goods for which a licence is sought:

(pursuant to section 5(2) of the Act)

Is the applicant a pharmacist, veterinary practitioner or wholesaler?

(If yes, specify which.)

Names and addresses of premises at which the goods may be stored at any stage, including the

point(s) of sale by this applicant:

(Attach extra pages if necessary)

Name Address







Declaration:

I declare that the above is a complete list of premis s at which goods subject to wholesale under this

licence may be stored before they are disposed of by this applicant, and that each of these premises

is available for inspection by an authorised officer. Access to any of these premises pursuant to the

Act may be obtained by contacting the person whose signature appears below.

Signature of applicant:

(Where the applicant is a company - a Director or the Secretary)

Signatory’s position in company:

Date of signature:

Contact details for the signatory:

Tel No:

Fax No:

Email:



Therapeutic Goods Regulations 2011 SCHEDULE 1




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FORM 4

(Regulation 6)

APPLICATION FOR LICENCE TO MANUFACTURE THERAPEUTIC GOODS

Name of applicant:

Applicants Qualification:

Applicant’s business address:

Applicant’s postal address:

Premises/buildings at which any step in manufacture occurs, including the premises/buildings of

any contract manufacturers: (Attach extra pages if necessary)

Name of site Street address Class of therapeutic goods





Persons who are to have control of the production of the goods and of the quality control measures

that are to be employed:

(Attach additional pages if necessary)

Name of person Name of site(s) Responsibility Qualific tion and experience





Declaration:

I declare that:

(a) Standards at each of these premises conform with the Ministry of Health, standards in

Good Manufacturing Practices.

(b) All of these premises are available for inspection by an authorised officer.

(c) Access to any of these premises under the terms of those Acts may be obtained by

contacting the person whose signature appears below.

Signature of applicant:

(Where the applicant is a company - a Director or the Secretary )

Signatory’s position in company:

Date of signature:

Contact details for the signatory:

Tel No:

Fax No:

Email:

SCHEDULE 2 Therapeutic Goods Regulations 2011




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FORM 5

(Regulation 7)

APPLICATION FOR INCLUSION OF MEDICINAL DRUGS IN THE
REGISTERED LIST

Name of applicant:

(May be the name of a registered company in Tonga or of a Tongan resident)

Applicant’s business address:

Applicant’s postal address:

Medicinal Drug

Brand name:

Non-propriety Name (INN):

Place of Manufacture:

Is it of United States Pharmacopoeia or British Pharmacopoeia standard or proven equivalent

standard?

Is it registered in any of the countries listed in the schedule to the Therapeutic Goods Act 2001?

Would it be appropriate for use in Tonga?

What class in the registered list is it likely to be included in?

Attach a World Health Organization Certificate for a Pharmaceutical Product Moving in

International Commerce signed by the government regulatory authority in a country which is a

signatory to the World Health Organisation Certificat on Scheme.



Declaration:

I declare that the above information is accurate and correct to the best of my knowledge and all

attached information has been obtained from the government regulatory authority of the

manufacturing country who is a signatory to the World Health Organisation Certification Scheme.



Signature of applicant:

Date of signature:

Contact details for the signatory:

Tel No:

Fax No:

Email:



Therapeutic Goods Regulations 2011 SCHEDULE 2




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SCHEDULE 2

(Regulation 9)

FEES


Item Activities Fees

1 Inclusion of a new medicinal drug in the Registered List $10.00

Import

2 Application for an import licence $20.00

3 Inspection fee relating to an import licence $50.00

4 Issuance fee for an import licence $200.00

Manufacturing

5 Application fee for a manufacturing licence $20.00

6 Inspection fee relating to a manufacturing licence $200.00

7 Issuance fee for a manufacturing licence $500.00

Supply other than by Wholesale

8 Application by retail stores selling Class 1 medicinal drugs only, for

licence to supply medicinal drugs other than by wholesale

NIL

9 Application by persons other than retail stores selling Class 1

medicinal drugs only, for licence to supply medicinal drugs other than

by wholesale

$20.00

10 Issuance fee to persons other than retail stores selling Class 1

medicinal drugs only, for licence to supply medicinal drugs other than

by wholesale

$100.00

Supply by Wholesale

11 Application fee for licence to supply therapeutic goods by wholesale $20.00

12 Issuance fee for licence to supply therapeutic goods by wholesale $200.00







SCHEDULE 3 Therapeutic Goods Regulations 2011




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SCHEDULE 3

(Regulation 10)

LICENCE

(Therapeutic Goods Act)

National Drugs and Medical Supplies Committee



This is to certify that .................................................... who operates a premises located

at ............................................................................................................ and owned by

.................................................... who is the registered owner, has been granted a licence

pursuant to the Therapeutic Goods Act 2001 and the Therapeutic Goods Regulations 2011

allowing the following activities:

................................................................................

................................................................................

................................................................................

................................................................................





The licence is issued this ............... day of ....................................... 20..........



Licence No:............................................

......................................

Chairman



This Licence must be retained and displayed upon the premises at all times.

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