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The Certificate has been withdrawn, withdrawn date is : 2023-12-15

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Landesamt Fuer Soziales Jugend Und Versorgung

CERTIFICATE NUMBER: DE_RP_01_GMP_2023_0035

CERTIFICATE OF GMP COMPLIANCE OF A MANUFACTURER(1) , (2)

Part 1

Issued following an inspection in accordance with
Art. 111(5) of Directive 2001/83/EC as amended
Art. 15 of Directive 2001/20/EC as amended

The competent authority of Germany confirms the following:

The manufacturer: BioNTech Manufacturing GmbH

Site address:

An Der Goldgrube 12, Oberstadt, Mainz, Rhineland-Palatinate, 55131, Germany

OMS Organisation Id. / OMS Location Id.: ORG-100030215 / LOC-100047650

DUNS Number: 31-438-2536

Has been inspected under the national inspection programme in connection with manufacturing authorisation no. DE_RP_01_MIA_2023_0020 in accordance with Art. 13 of Directive 2001/20/EC and Art. 40 of Directive 2001/83/EC, transposed in the following national legislation:Sect. 13 para 1 German Medicinal Product Act (manufacture) and § 72 German Medicinal Product Act (import) and Sect. 13 para 1 German Medicinal Product Act (manufacture) and § 72 German Medicinal Product Act (import).

From the knowledge gained during inspection of this manufacturer, the latest of which was conducted on 2023-07-13 , it is considered that it complies with:

The principles and guidelines of Good Manufacturing Practice laid down in Directive (EU) 2017/1572 and/or Commission Delegated Regulation (EU) 2017/1569, as reflected by the product categories stated in Part 2. (3)

This certificate reflects the status of the manufacturing site at the time of the inspection noted above and should not be relied upon to reflect the compliance status if more than three years have elapsed since the date of that inspection. However, this period of validity may be reduced or extended using regulatory risk management principles by an entry in the Restrictions or Clarifying remarks field. Updates to restrictions or clarifying remarks can be identified through the EudraGMDP website (https://eudragmdp.ema.europa.eu/). This certificate is valid only when presented with all pages and both Parts 1 and 2.

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

__________________________________________________________________________________________________________________________

(1) The certificate referred to in paragraph Art. 111(5) of Directive 2001/83/EC and Art. 15 of Directive 2001/20/ECis also applicable to importers.
(2) Guidance on the interpretation of this template can be found in the Interpretation of the Union format for GMP certificate.
(3) These requirements fulfil the GMP recommendations of WHO.

Part 2

Human Medicinal Products
Human Investigational Medicinal Products

1 MANUFACTURING OPERATIONS

1.3 Biological medicinal products (list of product types)

   1.3.1  Biological medicinal products (list of product types)
           1.3.1.4  Gene therapy products
   1.3.2  Batch Certification (list of product types)
           1.3.2.4  Gene therapy products
           1.3.2.8  Other: APIs of genetically-engineered origin: RNA constructs(en)

1.4 Other products or manufacturing activity

1.4.1 Manufacture of
1.4.1.3 Other: APIs of genetically-engineered origin: RNA constructs for manufacturing of RNA-based vaccines BNT-162 (Starting material DNA PCR fragment or linearized plasmid DNA)(en)

1.6 Quality control testing

   1.6.1  Microbiological: sterility
   1.6.3  Chemical/Physical
   1.6.4  Biological

Clarifying remarks (for public users):

Concerning Manufacturing Operations of Medicinal Products: Ad 1.4.1.3) The authorisation is limited to the production of the following RNA constructs: BNT-162b2 (Tozinameran(R)). Concerning manufacturing Operations of Human Ivestigational Medicinal Products: Ad 1.4.1.3) The authorisation is limited to the production of the following RNA constructs: BNT-162a1, BNT-162b1, BNT-162b2, BNT-162b5 and BNT162b2/ BNT162b5 variants of the drug substance product family) Ad 1.3.1.4 and 1.3.2.4) In vitro transcribed RNAs for individualized immunotherapy against cancer (Autogenous Cevumeran Approach, automated), manufacturing of RNA Lipoplex drug product Concerning Manufacturing Operations Human Medicinal Products and Human Investigational Medicinal Products: Ad 1.3.2.8 and 1.4.1.3) The authorisation is limited to the production of the following RNA constructs: BNT-162a1, BNT-162b1 and BNT-162b2. Manufacturing activities take place in following rooms: Quality Control: Groun (text missing)

Withdrawal comments in English: GMP certificate has been superseded by document with the number DE_RP_01_GMP_2023_0052

Withdrawal comments in National Language: Das GMP-Zertifikat wurde ersetzt durch das Dokument mit der Nummer DE_RP_01_GMP_2023_0052

The EudraGMDP database is maintained and operated by the EMA. Access to the general public is granted in order to enhance availability of information related to the EMA mandate. The content of the database is provided by the National Competent Authorities (NCA) of the EEA. For this reason, the EMA accepts no responsibility or liability whatsoever (including but not limited to any direct or consequential loss or damage it might occur to you and/or any other third party) arising out of or in connection with the information on this database. Any questions about the content should be addressed to the relevant NCA. Please click here to get list of NCA's.

For the UK, as from 1.1.2021, EU Law applies only to the territory of Northern Ireland (NI) to the extent foreseen in the Protocol on Ireland/NI.

Documents issued by UK authorities up to and including 31 December 2020 remain available for consultation in EudraGMDP. However, they are no longer included or updated from 1 January 2021, with the exception of the documents pertaining to sites located in Northern Ireland.