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A n tU d aras Rialala Tairgi Siainte

Health Products Regulatory Authority

Health Products Regulatory Authority

CERTIFICATE NUMBER: 19383/M46

C E R T IF IC A T E O F G M P C O M P L IA N C E O F A M A N U F A C T U R E R
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Part 1_____________________________________________________________________
Issued following an inspection in accordance with :
Art. 111(5) of Directive 2001/83/EC as amended
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The competent authority of Ireland confirms the following:
The manufacturer: LEO Laboratories Ltd
Site address: 285 Cashel Road, Crumlin, Dublin 12, D12 E923, Ireland
Has been inspected under the national inspection programme in connection with manufacturing
authorisation no. 46 in accordance with Art. 40 of Directive 2001/83/EC transposed in the following
national legislation:
Medicinal Products (Control o f Manufacture) Regulations 2007 to 2013.

From the knowledge gained during inspection of this manufacturer, the latest of which was conducted on
2018-02-07, it is considered that it complies with :
• The principles and guidelines of Good Manufacturing Practice laid down in Directive 2003/94/EC ’
This certificate reflects the status of the manufacturing site at the time of the inspection noted above and
should not be relied upon to reflect the compliance status if more than three years have elapsed since the date
of that inspection. However, this period o f validity may be reduced or extended using regulatory risk
management principles by an entry in the Restrictions or Clarifying remarks field. This certificate is valid
only when presented with all pages and both Parts 1 and 2. The authenticity of this certificate may be verified
in EudraGMDP. If it does not appear, please contact the issuing authority.

1 The certificate referred to in paragraph 111(5) o f Directive 2001/83/EC and 80(5) o f Directive 2001/82/EC, shall also be requiredfor imports
comingfrom third countries into a Member State.
2 Guidance on the intei-pretation o f this template can be found in the Help menu o f EudraGMDP database.
3 These requirements fulfil the GMP recommendations o f WHO.
I certify that that this document is a true and
faithful copy of the riginal document or of the
relevant extracts reto produced to me and
which afteo [examination I attest
this 2 J 0f 3 r j / u c u t A }

Hugh McGrodd/TsJotary Public'

33 Upper Merrion St., Dublin 2 .
Commissioned fo Life

Online EudraGMDP, Rel key: 47480 Issuance Date: 2018-04-13 Signatory: Mr. Greg McGurk Page 1 of 3

An tUdaWs Ria a>a Tairgi Siainte, Teach Kevin O 'M alley, lonad Phort an larla, Ardan Phort an larla, Baile Atha Cliath 2, Eire
Health Products Reguiatory Authority, Kevin O 'M alley House, Earlsfort Centre, Earlsfort Terrace, Dublin 2, D02XP77, Ireland

T: + 3 5 3 1 676 4971 F: + 353 1 676 7836 info@hpra.ie

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by Consular Affairs
Indonesian Embassy • London
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For ths Ambassador

The Embassy o f the Republic o f Indonesia assumes no

responsibility fo r the contents o f the annexed document

Seen for the authentication of signature/seal

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_____ Hugh Me Groddy--------------
Notary .Public iS b lW S *
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Date 30/01/2019
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This i ^ ^ j j t k | » w o n l y certifies the authenticity of th e signature and the
capacity ot|trijftp*fson w ho h a s signed th e public docum ent, and, w here
a p p r & h a i a j j ^ ^ e n t i t y of th e se al or sta m p which th e public docum ent
b e a r# :.th ifl|i^ re n tic a tio n d o e s not certify th e c o ntent of th e docum ent for
which i t W MifiSued. To verify an Authentication issu e d by th e Ministry of
Foreigr^Jpraire in Ireland, s e e w w w.authentications.dfat.ie
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H PRA^
A n tU daras Rialala Tairgi Slainte
H e alth Products Regulatory Authority

P art 2

Human Medicinal Products

1 M A N U FA C TU R IN G O PER A TIO N S
1.1 Sterile products
1.1.1 Aseptically prepared (processing operations fo r the following dosage forms)
1.1.1.3 Semi-solids

1.1.3 Batch certification

1.2 Non-sterile products

1.2.1 Non-sterile products (processing operations fo r the following dosage forms)
1.2.1.4 Impregnated matrices
1.2.1.5 Liquids for external use
1.2.1.9 Pressurised preparations
1.2.1.11 Semi-solids

1.2.2 Batch certification

1.5 Packaging
1.5.1 Primary Packing
1.5.1.4 Impregnated matrices
1.5.1.5 Liquids for external use
1.5.1.9 Pressurised preparations
1.5.1.11 Semi-solids

1.5.2 Secondary packing

1.6 Quality control testing

1.6.1 Microbiological: sterility
1.6.2 Microbiological: non-sterility
1.6.3 Chemical/Physical

Online EudraGMDP, Ref key: 47480 Issuance Date: 2018-04-13 Signatory: Mr. Greg McQurk Page 2 of 3

An tUdaras Rialala Tairgi Slainte, Teach Kevin O 'M alley, lonad Phort an larla, Ardan Phort an larla, Baile Atha Cliath 2, Eire
Health Products Regulatory Authority, Kevin O 'M a lley House, Earlsfort Centre, Earlsfort Terrace, Dublin 2, D02XP77, Ireland

T: + 353 1 676 4971 info@hpra.ie w w w .hpra.ie

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H PRA^
A n tUdaras Rialala Tairgi Slainte
H ealth Products Regulatory Authority

2018-04-13 Name and signature o f the authorised person o f the

Competent Authority o f Ireland

Online EudraGMDP, Ref key: 47480 Issuance Date: 2018-04-13 Signatory: Mr. Greg McGurk Page 3 of 3

A n t U d a r a s R ia la la T a ir g i S la in te , Teach Kevin O 'M alley, lonad Phort an larla, Ardan Phort an larla, Baile Atha Cliath 2, Icire
H e a lth P r o d u c ts R e g u la to r y A u t h o r ity , Kevin O 'M a lley House, Earlsfort Centre, Earlsfort Terrace, Dublin 2, D02XP77, Ireland

T: +353 1 676 4971 F: +353 1 676 7836 info@hpra.ie w w w .hp ra.ie

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