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The Certificate has been invalidated, invalidated date is : 2024-06-12

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State Institute For Drug Control

CERTIFICATE NUMBER: sukls15194/2024

CERTIFICATE OF GMP COMPLIANCE OF A MANUFACTURER

Part 1

The competent authority of Czechia confirms the following:

The manufacturer: ALS Czech Republic s.r.o.

Site address:

Na Harfe 336/9, Vysocany, Prague, 190 00, CZECHIA

OMS Organisation Id. / OMS Location Id.: ORG-100013530 / LOC-100018983

Has been inspected under the national inspection programme in connection with manufacturing authorisation no. sukls58552/2020 in accordance with Art. 40 of Directive 2001/83/EC, transposed in the following national legislation:Section 62 of the Act No 378/2007 Coll., on Pharmaceuticals and on Amendments to Some Related Acts, as amended.

From the knowledge gained during inspection of this manufacturer, the latest of which was conducted on 2024-02-29 , it is considered that it complies with:

The authenticity of this certificate may be verified in EudraGMDP. If it does not appear, please contact the issuing authority.

Part 2

Human Medicinal Products

1 MANUFACTURING OPERATIONS

1.6 Quality control testing

   1.6.2  Microbiological: non-sterility
   1.6.3  Chemical/Physical
   1.6.4  Biological

2 IMPORTATION OF MEDICINAL PRODUCTS

2.1 Quality control testing of imported medicinal products

   2.1.2  Microbiological: non-sterility
   2.1.3  Chemical/Physical
   2.1.4  Biological

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