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CERTIFICATE No. GIF-IW-N-4022/279/12

Main Pharnutccutica! inspectór

CERTIFICATE OF GMP COMPLIANCE OF A MANUFACTURER

Part 1

Issucd foUowi ng an inspection In accordanco with Art. 111(5) of Diroctwc 2001/83/EC as amended

Main Pharmaceutical Inspectór

flh* Compo<>x-K Ai/ftonty ot Potood confirms the fo*owing:

tho manufacturer

BALTON Sp. z o.o.

7/14, Nowy Świat Str.. 00-496 Warszawa, POLAND

sito a<J<Jross

BALTON Sp. z o.o.

294, Modlińska Str., 03-152 Warszawa, POLAND

has be en inspectod under tho national inspection programme m conncction with manufacturing authorisation No. GIF-IW-N-4001/WTC058/46/12 in accordance with Art 40 of Directwe 2001/83/EC trargposed in pharmaceutical law of 6*’ of September 2001 (Dz. U. z 2008 r Nr 45. poz. 271. z późn. zm.).

From the knowtedge gained dorrng inspoction of th:s manufacturer. tho latest of which was conducted on 23-24M0/2012. it is considered that it complies with tho Good Manufacturing Practico reguiremonts lad down in Diroctivo 2003/94/EC.

This cortificato roflocts tho status of the manufacturing sito a: tho timo of tho inspoction notod abovc and shoutd not bc rchcd upon to rcflcct tho complianc© status if morę than three years have etapscd sińce the datę of that inspection. after which time the issuing authority should be consulted.

This certificale is va!id only when presented with alt pages and both Parts 1 and 2. The authenticity of th*s certifcate may be verified wrth the issuing authority.

Mjln Ph»rmjC0vt)CJl InłpcctOfilc 58/40. DM31 Sir . CO-2J8 W»r»*w. p»'jnd TcL •** 22 C3S 99 SI. tox. 22 6JS 99 57

Zofia U Iz

Main Pharmaceutical Inspectór