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The Certificate has been withdrawn, withdrawn date is : 2023-11-13

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Swedish Medical Products Agency

CERTIFICATE NUMBER: 5.9.1-2021-099362

CERTIFICATE OF GMP COMPLIANCE OF A MANUFACTURER

Part 1

The competent authority of SWEDEN confirms the following:

The manufacturer: Novavax AB

Site address:

Kungsgatan 109, Danmark-Funbo, Uppsala, 753 18, Sweden

OMS Organisation Id. / OMS Location Id.: ORG-100019221 / LOC-100027986

Has been inspected under the national inspection programme in connection with manufacturing authorisation no. 5.9.1-2021-099362 in accordance with Art. 13 of Directive 2001/20/EC and Art. 40 of Directive 2001/83/EC.

Other

Distant Assessment

From the knowledge gained during inspection of this manufacturer, the latest of which was conducted on 2021-02-19 , 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
Human Investigational Medicinal Products

1 MANUFACTURING OPERATIONS

1.1 Sterile products

1.1.3 Batch certification

1.4 Other products or manufacturing activity

1.4.1 Manufacture of
1.4.1.3 Other: adjuvant(en)

1.5 Packaging

1.5.2 Secondary packaging

1.6 Quality control testing

1.6.3 Chemical/Physical

2 IMPORTATION OF MEDICINAL PRODUCTS

2.1 Quality control testing of imported medicinal products

2.1.3 Chemical/Physical

Clarifying remarks (for public users):

1.1.3, 1.4.1.3, 1.5.2, 1.6.3 Covers labelling, secondary packaging, quality control testing and batch certification of adjuvant, solution for injection in vials, for further compounding of vaccine in conjunction with administration for use in clinical trials of human investigational medicinal products. 1.6.3, 2.1.3 The authorisation also includes quality control testing of vaccine finished drug product, as well as imported, for human medicinal products. This certificate has been granted on the basis of a distant assessment.

Withdrawal comments in English: Replaced by certificate no 6.2.1-2023-054033.

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