Transcript Download - Swiss Stem Cell Foundation

THIS IS AN OFFICIAL TRANSLATION OF THE LEGAL BINDING
ORIGINAL ITALIAN VERSION.
Authorization
• Production of standardised explants
• Export of standardised explants
Object
- First authorization granted to the Swiss Stem Cell Foundation.
- This authorization is numbered 510270.
- This authorization is based on application No. 102510061.
In consideration of
- application No. 102510061 submitted by the Swiss Stem Cell Foundation on January 15, 2014
for first concession,
- the fact that the examination of the submitted application is a service subject to a fee
and based on
- articles 6 (manufacturing), 19 (import, export and trade in foreign countries), 28 (wholesale
trade) on the applicable Act on therapeutic agents (LATer; RS 812.21), along with/in the
combination of provisions of article 49 of the Act on transplants (RS 810.21)
- article 3 (production), 7 (import, wholesale trade and export), 12 (trade with foreign countries),
15 (taking of blood for transfusion or for producing medication), article 27 and 28 of the
Regulation on the authorization of medication dated October 17, 2001 (OAM; RS 812.212.1),
as well as
- article 3, section 1, and article 4, section 1, in relation to Ietter a, number IV of Appendix 5 to
the Regulation on the emoluments of the Swiss Agency for Therapeutic Products (OEAT; RS
812.214.5),
t h e
f o l l o w i n g
i s
d e c i d e d :
1. Authorized operator
Swiss Stem Cell Foundation
Via Tesserete 48
6900 Lugano
2. Authorization is granted for the following activities:
•
Production of standardised explants (number of sites: 1)
•
Export of standardised explants (number of sites: 1)
3. The provisions set forth in the Appendices hereto shall be equally applicable.
4. The authorization is valid from the date of issue to January 29, 2019.
Page 1 of 4
Schweizerisches Heilmittelinstitut
Institut Suisse des produits thérapeutiques
Istituto svizzero per gli agenti terapeutici
Swiss Agency for Therapeutic Products
I-301.AA.01-A08i / V12 / gme / cza / smi / 01.11.2013
Swissmedic I Hallerstrasse 7 I Postfach I CH-3000 Bern 9 I www.swissmedic.ch I Tel. +41 31 322 02 11 I Fax +41 322 02 12
Swiss Stem Cell Foundation, 6900 Lugano
Authorization No. 510270 / Application No. 102510061
5. The fee amounts to CHF 1’000.- and must be paid by the applicant.
Bern, January 30, 2014
Swissmedic, the Swiss Agency for Therapeutic Products
Authorization Department
The Head of the Transplant Unit
The Inspector
Dr. Julia Djonova
Dr. Martin Burgener
Legal recourse:
It is possible to seek recourse against this decision within 30 days of the notification
thereof. The recourse must be sent to the Federal Administrative Court, PO BOX 9023,
San Gallo, (Art. 31 and 33 letter e of Federal Act of June 17, 2005, on the Federal
Administrative Court; RS 173.32). The recourse deed must include the conclusions,
reasons, and the specification of the evidence and bear the signature of the appealer or
representative thereof. The impugned decision must be provided in attachment, as well as
the documents specified as evidence, if in possession of the appealer (Art. 52 of Federal
Act of December, 20 1968 on the administrative procedure; RS 172.021).
Copy to:
- Ticino Cantonal Pharmacist
Page 2 of 4
Schweizerisches Heilmittelinstitut
Institut Suisse des produits thérapeutiques
Istituto svizzero per gli agenti terapeutici
Swiss Agency for Therapeutic Products
I-301.AA.01-A08i / V12 / gme / cza / smi / 01.11.2013
Swissmedic I Hallerstrasse 7 I Postfach I CH-3000 Bern 9 I www.swissmedic.ch I Tel. +41 31 322 02 11 I Fax +41 322 02 12
Swiss Stem Cell Foundation, 6900 Lugano
Authorization No. 510270 / Application No. 102510061
Appendix 1: Production of standardised explants
Site 1:
Swiss Stem Cell Foundation
Technoparkstrasse 1
8005 Zurich
Technical Head:
Emmendoerffer, Andreas
Doctor
Date of birth: April 08, 1959
Authorized activities/conditions/reserves:
Production of cell therapy products for clinical experimentation
for autogenous transplants
Production of tissue products for clinical experimentation
for autogenous transplants
Page 3 of 4
Schweizerisches Heilmittelinstitut
Institut Suisse des produits thérapeutiques
Istituto svizzero per gli agenti terapeutici
Swiss Agency for Therapeutic Products
I-301.AA.01-A08i / V12 / gme / cza / smi / 01.11.2013
Swissmedic I Hallerstrasse 7 I Postfach I CH-3000 Bern 9 I www.swissmedic.ch I Tel. +41 31 322 02 11 I Fax +41 322 02 12
Swiss Stem Cell Foundation, 6900 Lugano
Authorization No. 510270 / Application No. 102510061
Appendix 2: Export of standardised explants
Site 1:
Swiss Stem Cell Foundation
Technoparkstrasse 1
8005 Zurich
Technical Head:
Emmendoerffer, Andreas
Doctor
Date of birth: April 08, 1959
Authorized activities/conditions/reserves:
Export of cell therapy products ready for use
for autogenous transplants
Export of tissue products ready for use
for autogenous transplants
Page 4 of 4
Schweizerisches Heilmittelinstitut
Institut Suisse des produits thérapeutiques
Istituto svizzero per gli agenti terapeutici
Swiss Agency for Therapeutic Products
I-301.AA.01-A08i / V12 / gme / cza / smi / 01.11.2013
Swissmedic I Hallerstrasse 7 I Postfach I CH-3000 Bern 9 I www.swissmedic.ch I Tel. +41 31 322 02 11 I Fax +41 322 02 12