Bpm novartis pharma ag. stein suiza jrc cdi-ger-01-1 (se recuperó)
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2013 17 01 17 D medic CERTIFICATE OF GMP COMPLIANCE (for the Health Authorities of Ecuador) We certify herewith that the company Novartis Pharma Stein AG, Pharmaceutical Operations Schweiz. Schaffhauserstrasse, 4332 Stein, Switzerland, has bi ,11- 1 duly authorized to manufacture and distribute medicinal products and investigational medicinal products, the manufacturing licence including following dosage forms: liquid dosage forms (including aseptically prepared forms and terminally sterilised forms as well as biological and highly active or sensitising products) - solid dosage forms (including aseptically prepared forms as well as biological and highly active or sensitising products) transdermal systems including following activities: Quality control (chemical, physical and biochemical) of medicinal products as contract laboratory Quality control (biological) of medicinal products as contract laboratory - Quality control (microbiological) of medicinal products as contract laboratory including tests of sterility that the finished medicinal products put on the market in Switzerland by the company are subject to appraisal and authorisation by our agency; that the company is keeping the required level for good practices in the manufacture of pharmaceutical products 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 Inspection Convention /Co-operation Scheme (PICTS) 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 April 11-13, 2012: that the requirements regarding manufacture and quality control for pharmaceutical products for export are identical to those applicable to products sold in Switzerland. Berne, September 10, 2012 Swismedic, Swiss Agency for No. 12-1747 1helt* Products e Schwerzensches HeiimitteIinstitut Institut suisse des products therapeutiques Istituto syizzero per gli agenti terapeutici Swiss Agency for Therapeutic Products NOTARLA DECIMO SEPT1MA Shyris y Suecia Esq. (Dr y Vorlage. :-303 AA 01-A4_02 Swissmedic Hallerstrasse 7 I Postfach I CH-3000 Bern 91 www.swissmedic,ch I Tel. +41 31 322 02 11 1 Fax +41 31 322 02 12
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Transcript of Bpm novartis pharma ag. stein suiza jrc cdi-ger-01-1 (se recuperó)
2013 17 01 17 D medic
CERTIFICATE OF GMP COMPLIANCE (for the Health Authorities of Ecuador)
We certify herewith
that the company Novartis Pharma Stein AG, Pharmaceutical Operations Schweiz. Schaffhauserstrasse, 4332 Stein, Switzerland, has bi ,11-1 duly authorized to manufacture and distribute medicinal products and investigational medicinal products, the manufacturing licence including following dosage forms:
liquid dosage forms (including aseptically prepared forms and terminally sterilised forms as well as biological and highly active or sensitising products)
- solid dosage forms (including aseptically prepared forms as well as biological and highly active or sensitising products) transdermal systems
including following activities: Quality control (chemical, physical and biochemical) of medicinal products as contract laboratory Quality control (biological) of medicinal products as contract laboratory
- Quality control (microbiological) of medicinal products as contract laboratory including tests of sterility
that the finished medicinal products put on the market in Switzerland by the company are subject to appraisal and authorisation by our agency;
that the company is keeping the required level for good practices in the manufacture of pharmaceutical products 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 Inspection Convention /Co-operation Scheme (PICTS) 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 April 11-13, 2012:
that the requirements regarding manufacture and quality control for pharmaceutical products for export are identical to those applicable to products sold in Switzerland.
Berne, September 10, 2012 Swismedic, Swiss Agency for No. 12-1747 1helt* Products
e
Schwerzensches HeiimitteIinstitut Institut suisse des products therapeutiques Istituto syizzero per gli agenti terapeutici Swiss Agency for Therapeutic Products
NOTARLA DECIMO SEPT1MA Shyris y Suecia Esq.
(Dr y
Vorlage. :-303 AA 01-A4_02
Swissmedic Hallerstrasse 7 I Postfach I CH-3000 Bern 91 www.swissmedic,ch I Tel. +41 31 322 02 11 1 Fax +41 31 322 02 12
APOSTILLE (Convention de la Haye du 5 octobre 1961)
1. Pais: CONFEDERACION SUIZA,
Ei presente documento poblico
2. ha sido firmado por Michel Keller
3. actuando en calidad de funcionario
4. se halla selladoitimbrado con Swissmedic
Institute suizo de los productos terapeuticos
Certificado
5. en Serra 6. el 1 7. SEP. E12
7. per Alessandra Manoiero
funcionaria de la Cancilleria de la Confederacion Suiza
1 5 g 8. con el nOrnero 0 7 .2 Selioltimbre 10. Firma
ancilleria de is Confederation Suiza
Atentamente,
Cascante M.
Director General
2013 17 01 17D
ncURACY RESEARCH ;nvestigoc ∎ n en Schni Co. Ltda.
CERTIFICADO
El abajo firmante certifica que el contenido de la documentaciOn aqui incluida es una
traduccion exacta y fiel del documento original del CERTIFICADO DE CUMPLIMIENTO
DE BPM DE UN FABRICANTE No. 12-1747 emitido en Berna, Suiza el 0 de Septiembre de 2012 para el fabricante Novartis Pharma Stein AG, Pharmaceutical Operations Schweiz.
SWAIM DECIMO SEPRMA (AL (AWL* AUrC De armee& con teutte consglado 111 01 M. in,
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2013 17 01 17 D
CERTIFICADO DE CUMPLIMIENTO DE BPM
(Para as Autoridades de Salud de Ecuador)
En este documento nosotros certificamos
que la compania Novartis Pharma Stein AG, Pharmaceutical Operations Schweiz, Schaffhauserstrasse, 4332 Stein, Suiza, na sido debidamente autorizada para fabricar y distribuir productos medicinales y productos medicos de investigacion, la licencia de fabricacion inctuye las siguientes formas farmaceuticas'
- formes de dosificaciones liquidas (incluyendo formas preparadas asepticamente y formas terminalmente esterilizadas asi coma productos biolOgicos y altamente activos o sensibilizantes) formas de dosificaciones solidas (incluyendo formas preparadas asepticamente asi coma productos bialagicos y altamente activos o sensibilizantes)
- sistemas transdermicos
incluyendo as siguientes actividades:
Control de calidad (quimico, fis co y bioquimico) de productos medicinales coma laboratorio par contrato
- Control de calidad (b ologico) de productos medicinales coma laboratorio par contratc Control de calidad (microbiological de productos medicinales como laboratorio par contrato incluyendo pruebas de esterilidad
que los productos medicinales terminados puestos en el mercado de Suiza por Ia compania estan sujetos a evaluacion y autorizacion por nuestra agencia;
que is compania mantiene el nivel requerido para las buenas practicas de fabricacion de productos farmaceuticos de acuerdo a las regulaciones suizas vigentes. Estas regulaciones estan de acuerdo con los requerimientos para as buenas practicas en la fabricacion y control de calidad de la Convencion de
Inspeccion Farmaceutica/Plan de Cooperacian (PIC/S, por sus siglas en ingles) y las Directrices de Ia Comision Europea
que la planta de fabricacion de la compania esta sujeta a inspecciones oficialPs periadicas: la Ultima inspeccion regular fue reafizada en Abril 11-13, 2012,
que los requerimientos en relacian con la fabricacion y control de calidad para productos fermaceutioos para exportacian son identicos a aqueilos aplicabies a
los productos vendidos en Suiza
NOTARIA DECIMO SEPTIMA Shyris y Suecia Esq.
2013 170 7 © Berna, Septiembre 10, 2012 No. 12 -1747
Swissmedic, Aaencia Suiza pars Productos Terapeuticos
Michel Keller
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NOTARIA Shyris y Su
NO tAitIA 5E011j SEP 1 ItAA LILL LA1411)(1 ( IIC , .1‘e at.perde con b tecullz! onswgnada en el Art. trt, Lei Deueto M 733t publicaeo en el Re.pgre Mum *4 60112 de MA de 1573. dire onpllu et Art 18 de
Nctr31 CERROCC cr:c la cor:u due arnooket--) -gual at presentado to et t:•'unu A.
NOTAR OECIMO SEPTIMA Shyris y Suecia Esq.
Wryttigio errrvecrt; V
2013 17 01 17 D
111UNLIMIIMIWA,ihM
