297b-who-redacted-geschw

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Vs siensano

Quality of Vaccines and Blood Products

Contact:

tel.: +32-2-642.53.39

  
 
 
 

erretariat: NCL.Biologicals@sciensano.be
tail: genevieve.waeterloos@sciensano.be

  
   

BE/22/0141
CERTIFICATE FOR THERELEASE OF COMIRNATY VACCINE
The following lot of COMIRNATY vaccine, Pandemic COVID-19 vaccine (mRNA),
produced by , whose number appears on the labels

of the final containers, meets all national requirements and complies with the relevant
specifications in the European registration file'-.

This product is manufactured and controlled in accordance with the requirements for Good
Manufacturing Practices for Pharmaceutical Products: Main Principles’, Good Manufacturing
Practices for Biological Products? and Guidelines for Independent Lot Release of Vaccines by
Regulatory Authorities®.

This certificate is based on examination of the summary protocol of manufacturing and control,
and independent laboratory testing.

Final Lot Nr Nr of released Expiry date
containers
in this final lot

BE EEE May 2022

Type of packaging: Vial
Number of doses per unit pack: 6 doses

The Chief of the National Control Laboratory

Digitally signed by
Date: 2022.01.20 11:14:04 +01'00'

' If any national requirements have not been met, specify which one(s) and indicate why the release of the lot(s) has nevertheless
been authorized by the NCL

2 with the exception of provisions on distribution and transport, which the NRA or NCL may not be in a position to assess.

?WHO Technical Report Series, Nr. 986, 2014, Annex 2

*WHO Technical Report Series, Nr. 999, 2016, Annex 2

®WHO Technical Report Series, Nr. 978, 2013, Annex 2

Form 42/11.04/21/E v3 Date of application : 01-07-2021 p-1/1

Sciensano - Rue Juliette Wytsmanstraat 14 - 1050 Brussels - Belgium
T+3226425111+F + 322642 50 01 + info@sciensano.be + www.sciensano.be

 

heolthy all life long
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