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1 License for the manufacture of drugs for the import of drugs for the wholesale trade of drugs Facts and circumstances Renewal of the license issued on 16 December 2010 for the company,,, company number This license has the number This license is based on the application number In consideration of the application number of the company dated 25 April 2013 for renewal, the request of the Regional Medicines Inspectorate of North-Western Switzerland dated 18 May 2012, the fact that examination of the received application is subject to a fee And based on Article 6 (Manufacture), 19 (Import, export, and foreign trade), 28 (Wholesale trade), 34 (Withdrawal of blood for transfusions or for the manufacture of drugs) of the Therapeutic Products Act dated 15 December 2000 (HMG; SR ), Article 3 (Manufacture), 7 (Import, wholesale trade, and export), 12 (Foreign trade), 15 (Withdrawal of blood for transfusions or for the manufacture of drugs), Articles 27 and 28 of the Ordinance on Establishment Licenses dated 17 October 2001 (AMBV; SR ), and Article 3 Paragraph 1 and Article 4 Paragraph 1 in conjunction with Letter a, Subparagraph IV of the Annex 5 to the Therapeutic Products Fees Regulation (HGebV; SR ), i t i s d e c r e e d a s f o l l o w s: 1. Owner of manufacturing license: 2. The license is granted for the following activities: Manufacture of drugs (number of facilities: 1) Import of drugs (number of facilities: 1) Wholesale trade of drugs (number of facilities: 1) 3. The facts and circumstances set forth in the Annexes will apply. Swiss Agency for Therapeutic Products Page 1/5 Hallerstrasse 7 PO Box CH-3000 Bern 9 Tel Fax
2 , 4. The license is valid from 23 July 2013 through 22 July The fee is set to CHF and imposed on the applicant. 6. This license supersedes the license mentioned under Facts and circumstances above from the validity date under Subparagraph 4. Bern, 17 June 2013 Swiss Agency for Therapeutic Products Licensing Sector Director Unit Companies and Certificates Inspector (Signature) Dr. Georges Meseguer (Signature) Dr. Roeland Op den Camp Explanation on rights of appeal: An appeal against this decree can be filed within 30 days of delivery. The appeal has to be submitted to the Federal Administrative Court, PO Box, 9023 St. Gallen (Articles 31 and 33 Letter e of the Federal Law dated 17 June 2005 on the Federal Administrative Court; SR ). The appeal shall set forth the requests and the reasons thereof including the means of evidence and the signature of the appellant or his/her procuration; the appealed decree and the documents called as means of evidence shall be attached (Article 52 of the Federal Law dated 20 December 1968 on the administrative procedure; SR ). Copy for information to: - Regional Medicines Inspectorate of North-Western Switzerland - Cantonal Pharmacist, Canton of Basel-Landschaft Swiss Agency for Therapeutic Products Page 2/5 Hallerstrasse 7 PO Box CH-3000 Bern 9 Tel Fax
3 , Annex 1: Manufacture of drugs Qualified Person: Manufacture of active pharmaceutical ingredients Aseptically prepared products are excluded Terminally sterilized products are excluded The processing of biological products is included The processing of highly active or allergenic substances is included Manufacturing of drugs for clinical trials Chemical, physical, and biochemical quality control of drugs as an external analytical laboratory Microbiological quality control of drugs as an external analytical laboratory Sterility testing is excluded Swiss Agency for Therapeutic Products Page 3/5 Hallerstrasse 7 PO Box CH-3000 Bern 9 Tel Fax
4 , Annex 2: Import of drugs Qualified Person: Import of finished drugs (without immunological drugs, blood, and blood products), excluding release for market Restricted to drugs for clinical studies Swiss Agency for Therapeutic Products Page 4/5 Hallerstrasse 7 PO Box CH-3000 Bern 9 Tel Fax
5 , Annex 3: Wholesale trade of drugs Qualified person: Wholesale trade of unfinished drugs (without immunological drugs and blood products) Wholesale trade of unfinished immunological drugs Wholesale trade of finished drugs (without immunological drugs, blood, and blood products) in Switzerland, excluding release for market Restricted to drugs for clinical trials Swiss Agency for Therapeutic Products Page 5/5 Hallerstrasse 7 PO Box CH-3000 Bern 9 Tel Fax
Your reference: Edmund F. Wyss Our reference: ocr Official in charge: Roel Op den Camp, phone no.: page 1/6.
page 1/6 Translation 05.01.2016/mmm Swissmedic Licence No. 504416/ Application No. 102540265 Injunction Licence - For manufacturing of pharmaceutical products - For wholesale of pharmaceutical products
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-Regulation (EC) No.1394/2007 -Regulation (EC) No. 668/2009
Introduction to Advanced Therapy Medicinal Products Regulation -Regulation (EC) No.1394/2007 -Regulation (EC) No. 668/2009 -Directive 2009/120/EC Dr. Maura O Donovan F.R.C.O.G. MA MD M.R.C.P.I. CAT member