Gmp compliance 2015 swissmedic

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sw smedic CERTIFICATE OF GMP COMPLIANCE

We certify herewith

that the company Früh Verpackungstechnik AG, Allmendstrasse 47,8320 Fehraltorf, Switzerland, has been duly authorized to manufacture and distribute medicinal products, the manufacturing licence including following packaging activities:

-

Secondary packaging

of

medicinal products

that the company is keeping the required level for good practices in the manufacture of pharmaceutical products and active pharmaceutical ingredients according to the Swiss regulations in force. These regulations are in accordance with the requirements for good practices in the manufacture and quality control of the Pharmaceutical lnspection Convention /Co-operation Scheme (PlC/S) and the Directives of the European Commission; that the manufacturing plant of the company is subject to official periodic inspections; the last regular inspection was conducted on July 10, 2014;

that the requirements regarding manufacture and quality control for pharmaceutical proáucts and active pharmaceutical ingredients for export are identical to those applicable to products sold in Switzerland.

Berne, August 17,2015 No. l5-1866

Swissmedic, Swiss Agency for Products

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Rvf

Schweizerisches Heilmittelinstitut lnstitut suisse des produits thérapeutiques lstituto svizzero per gli agenti terapeutici

SwissAgencyforTherapeuticProducts

l_303AA01-A14e/V01 Iliatgmetsmi /3005.1

SwissmediclHallerstrasseTlPostfachlCH-3000Bern9lwww.swissmedic.chlTel.+41 5846202 11 lFax+41 5846202

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