Your reference: Edmund F. Wyss Our reference: ocr Official in charge: Roel Op den Camp, phone no.: page 1/6.

Transcription

1 page 1/6 Translation /mmm Swissmedic Licence No / Application No Injunction Licence - For manufacturing of pharmaceutical products - For wholesale of pharmaceutical products - For export of pharmaceutical products Facts - Amendment of licence no based on application no for the company Amino AG, manufacturing of pharmaceutical and chemical products. - This licence has no This licence is based on application no Having regard to - The application no of the company Amino AG, manufacturing of pharmaceutical and chemical products, dated June 18, 2015, concerning change of scope, - The request of the Regionales Heilmittelinspektorat der Nordwestschweiz (Swiss northwestern regional drug inspection agency), dated December 01, The fact that the check of the received application is a service, which is subject to charge And based on - Article 6 (manufacturing), 19 (import, export and trading abroad), 28 (wholesale), 34 (taking of blood samples for transfustions or for manufacturing of pharmaceutical products) of the Therapeutic Products Act dated December 15, 2000 (Heilmittelgesetz HMG, SR ), - Article 3 (manufacturing), 7 (import, wholesale and export), 12 (trading abroad), 15 (taking of blood samples for transfusions or for manufacturing of pharmaceutical products), article 27 and 28 of the drug approval regulation dated October 17, 2001 (Arzneimittelbewilligungsverordnung AMBV ; SR ), as well as - Article 3, paragraph 1 and article 4, paragraph 1 in conjunction with letter A, figure IV of appendix 1 of the Regulation on fees for therapeutic products (Heilmittel- Gebührenverordnung HGebV ; SR ), is decreed: 1 SR=Systematische Rechtssammlung des Bundesrechts (systematical collection of federal law) (comment of translator)

2 page 2/6 1. Owner of establishment licence CH-5412 Gebenstorf 2. The licence is issued for the following activities : - Manufacturing of pharmaceutical products (number of operating sites : 2) - Wholesale of pharmaceutical products (number of operating sites: 1) - Export of pharmaceutical products (number of operating sites: 1) 3. Facts of the case apply as described in the appendices. 4. The licence is valid from date of issue until May 18, The fee is set to Swiss Francs and the applicant is charged. 6. This licence replaces by the date listed in (4) the licence named under «facts». Bern, December 09, 2015 Swissmedic, Swiss Agency for therapeutic products Marion Zimmermann Central printing (Zentraler Druck) Your contact: Division Licences, section certificates and licences Office phone Instruction on the right to appeal : A complaint against this injunction may be lodged within 30 days after notification. The complaint has to be submitted to the Bundesverwaltungsgericht (Federal Administrative Court), P.O. Box, CH-9023 St. Gallen (article 31 and 33, letter e of the Federal Law dated June 17, 2005 concerning the Federal Administrative Court ; SR ). The complaint must contain the demands, their justification, specifying documentary evidence and the signature of the complainant or his deputy ; the injunction appealed against and the documents used as evidence have to be enclosed (Article 52 of the Federal Law dated December 20, 1968 concerning the administrative procedure ; SR ). Copy to - Swiss northwestern regional drug inspection agency - Cantonal pharmacist, Aargau - Cantonal pharmacist, Berne

3 page 3/6 Appendix 1: Manufacturing of pharmaceutical products Operating site 1: CH Gebenstorf - In terms of liquid dosage forms o Included are products prepared aseptically o Included are terminally sterilized products - In terms of semi-solid dosage forms o Excluded are products prepared aseptically o Excluded are terminally sterilized products - In terms of solid dosage forms o Excluded are products prepared aseptically o Excluded are terminally sterilized products Manufacturing of investigational medicinal products (intermediate and ready-to-use products) Contract manufacturing according to article 9, paragraph 2bis HMG of pharmaceutical products not subject to approval according to article 9, paragraph 2, letter a-c bis HMG («Formula» products) Filling and labelling of raw material in container specific guaranteeing of identity as per chapter Ph.Helv. for manufacturing of pharmaceutical pruducts not subject to approval according to article 9, paragraph 2, letter a-c bis HMG ( Formula products)

4 page 4/6 Appendix 2 : Manufacturing of pharmaceutical products Operating site 2: Ämmenmattstrasse 2 CH-3123 Belp - In terms of liquid dosage forms o Included are products prepared aseptically, limited to aseptical products for topical application (e.g. eye drops, eyewash Zeller) o Included are terminally sterilized products - In terms of semi-solid dosage forms o Included are products prepared aseptically, limited to aseptical products for topical application (e.g. ointments and eye ointments) o Included are terminally sterilized products Manufacturing of investigational medicinal products (intermediate and ready-to-use medicinal products)

5 page 5/6 Appendix 3: Wholesale of pharmaceutical products Operating site 1: CH Gebenstorf Wholesale of pharmaceutical products not ready-to-use (excluding immunological drug products, and blood products) Wholesale of ready-to-use medicinal products (excluding immunological drug products, blood, and blood products) in Switzerland, including market release

6 page 6/6 Appendix 4: Export of pharmaceutical products Operating site 1: CH Gebenstorf Export of ready-to-use medicinal products - Excluding immunologial drug products - Excluding stable blood products