Chứng nhận nhà máy sản xuất thuốc Procare đạt GMP Australia

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----- Australian GovernmentDepartment of Health

Therapeutic Goods Administration

Certificate of GMPCompliance of a ManufacturerCertificate Number:

MI-2015-LJ-09887-1

Issued to:

Catalent Australia Pty LtdABN: 61 007 219 990

Manufacturing Site Address:

217-221 Governor RoadBRAESIDE VIC 3195

The Therapeutic Goods Administration, the Competent Authority of Australia, confirms that thismanufacturer holds a Licence with number MI-09112004-LJ-000138-1 to manufacturetherapeutic goods under Section 38 of the Therapeutic Goods Act, 1989 and is included in thenational inspection program following section 40(4)(b) ofthe Therapeutic Goods Act 1989.

From the knowledge gained during inspection of this manufacturer, the latest of which wasconducted on 15 to 18 December 2014, it is considered that the manufacturer complies with theGood Manufacturing Practice requirements of the PICjS Guide to Good Manufacturing Practicefor Medicinal Products - 15 January 2009.

This certificate reflects the status of the manufacturing site at the time of the inspection notedabove and should not be relied upon to reflect the compliance status after the expiry date. Thiscertificate should also not be relied upon where the status of the Licence to manufacturetherapeutic goods is not current. Where required, the Therapeutic Goods Administration as theissuing authority should be consulted.

EXPIRY DATE: 18 December 2017

ISSUE DATE: 10 September 2015

Name and signature of an authorised person of the Competent Authority of Australia:

Signed: .s:~_(lJ~~f~l""G~=''''''''''''''''''

anrfacturing Quality Branch

This certificate is valid only if the security provisto s ue and grey curved dotted lines on the bottom half of!,ac~page) are visible.

This certificate remains valid only if re- Inspections are conducted when scheduled by the Therapeun Gqod~€d' lni,tration.

The authenticity of this certificate may be verified with the Therapeutic Goods Administration as tn,!-!S~lngaUthorltyJ. ~ -"The status of an Australian Licence may be viewed at https:l/www.ebs.tga.gov.au{

PO Box 100 Woden ACT 2606 ABN 40 939 406 804Phone: 02 6232 8444 Fax: 0262328605 Email: [email protected] www.tga.gov.au

Page1of2

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~ Goods Administration Jrt':~jif-,<- Australia --!t<gY9;'Jr:~ I

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Australian GovernmentDepartment of Health

Therapeutic Goods Administration

Certificate of GMPCompliance of a ManufacturerCertificate Number:

MI-201S-LJ-09887-1

MANUFACTURING OPERATIONS

The manufacturer above is authorised under Section 38 of the Therapeutic Goods Act 1989 tocarry out jhe following steps in the manufacture of therapeutic goods at the manufacturing siteaddress specified above.

Manufacturing Type Sterility Dosage Form Product Category Manufacturing Step

Medicine manufacture Non Sterile Capsule, soft Registered Full Product Manufacture -Therapeutic Good excluding Microbiological Testing

Medicine manufacture Non Sterile Solid Unit Registered Full Product Manufacture-Dosage Forms Therapeutic Good excluding Microbiological Testing

In addition to the statutory conditions that apply to all Licences granted under Section 38 of theTherapeutic Goods Act, 1989, the following specific conditions have been imposed on this Licenceunder Sections 40(1) and/or 40(2) of the Therapeutic Goods Act 1989:

The licence does not authorise the manufacture of preparations containing penici\1ins,cephalosporins, hormones, steroids or antineoplastic drugs.

Name and signature of an authorised p/Jon of the Competent Authority of Australia:

Signed: J~.................................... , .

Gaye Cammcturing Quality Branch

This certificate is valid only if the security provtslo and grey curved dotted lines on the bottom half of each page) are visible.

This certificate remains valid only if re-Inspections are conducted when scheduled by the Therapeutic Goods Administration.

The authenticity of this certificate may be verified with the Therapeutic Goods Administration as the Issuing authority.

The status of an Australian Licence may be viewed at hnps:l!www ebs.tca.l'(w.an(

PO Box 100 Woden ACT 2606 ABN 40 939 406 804Phone: 02 6232 8444 Fax: 02 6232 8605 Email: [email protected] www.tga.gov.au llGAHealth S~fety

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Page 2 of 2

I certify that Vlis page and theoJ'i'f [r) pagetattached aI/ bearing my

notarial seal and signature aretrue and complete copies of the

originals.

CHARLES BERNARD GORE BRETINOTARY PUBLIC

LEVEL I. 12 COLLINS STREETMELBOURJ>iE, VICTORIA

AUSTRALIA

I, Viet-Anh Nguyen, an officer of the AustralianEmbassy, Hanoi, having been duly authorised by theSecretary of the Department of Foreign Affairs andTrade, DO HEREBY CERTIFY that thesignature/seal/stamp Charles Bemard Gore Brett, NotaryPublic, appearing on the docurnent/s attached hereto isthe true signature/seal/stamp of Charles Bemard GoreBrett. In so certifying, neither I nor the AustralianEmbassy, Hanoi endorse, verify or make any statement asto the accuracy, truth, legality or otherwise of thecontents of the document or the purposes for which thedocument may be used. Neither I nor the AustralianEmbassy, Hanoi accept liability for any loss, damage orinjury arising out of the use of, or reliance on, thedocument or its contents. I provide no undertaking that Ihave read the contents of the document.GIVEN under my Hand and the seal of the AustralianEmbassy, Hanoi the 22nd day of February, 2016.

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