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The Certificate has been withdrawn, withdrawn date is : 2023-11-09

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Agency For Medicinal Products And Medical Devices Of The Republic Of Slovenia

CERTIFICATE NUMBER: 409-2/2023-5

CERTIFICATE OF GMP COMPLIANCE OF A MANUFACTURER

Part 1

The competent authority of SLOVENIA confirms the following:

The manufacturer: Zhejiang Huahai Pharmaceutical Co. Ltd.

Site address:

Xunqiao Linhai City, Taizhou, 317024, China

OMS Organisation Id. / OMS Location Id.: ORG-100011833 / LOC-100018698

Has been inspected in connection with marketing authorisation(s) listing manufacturers located outside of the European Economic Area in accordance with Art. 111(4) of Directive 2001/83/EC.

From the knowledge gained during inspection of this manufacturer, the latest of which was conducted on 2023-07-08 , 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

1.2 Non-sterile products

   1.2.1  Non-sterile products (processing operations for the following dosage forms)
           1.2.1.13  Tablets
   1.2.2  Batch certification

1.6 Quality control testing

1.6.2 Microbiological: non-sterility
1.6.3 Chemical/Physical

Any restrictions related to the scope of this certificate:

Building	Room	Line/equipment	QC testing	Products
*Building F2*

Clarifying remarks (for public users):

The inspection was performed based on the request of the MIA holder KRKA, tovarna zdravil, d.d., Novo mesto, Šmarješka cesta 6, 8000 Novo mesto, Slovenija. The certificate is valid only for the manufacture of finished products from active ingredients, qualified by KRKA, tovarna zdravil, d.d.

Withdrawal comments in English: Updated certificate was issued.

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