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Swedish Medical Products Agency

CERTIFICATE NUMBER: SE-HI-GMP-25-056754

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

Part 1

Issued following an inspection in accordance with
Art. 63 of Regulation (EU) 536/2014 as amended

The competent authority of Sweden confirms the following:

The manufacturer: AstraZeneca AB

Site address:	Forskargatan 18, Sodertalje, 151 36, Sweden
Additional details on units inspected:	*Respiratory products and secondary packaging*

OMS Organisation Id. / OMS Location Id.: ORG-100001699 / LOC-100000556

Has been inspected under the national inspection programme in connection with manufacturing authorisation no. SE-HI-MIA-24-047232 in accordance with Art. 61 of Regulation (EU) No 536/2014.

From the knowledge gained during inspection of this manufacturer, the latest of which was conducted on 2025-05-23 , 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. 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 Investigational Medicinal Products

1 MANUFACTURING OPERATIONS

1.2 Non-sterile products

1.2.1 Non-sterile products (processing operations for the following dosage forms)
1.2.1.17 Other: Inhalation powder(en)

1.3 Biological medicinal products (list of product types)

1.3.1 Biological medicinal products (list of product types)
1.3.1.5 Biotechnology products

1.4 Other products or manufacturing activity

1.4.3 Other: See clarifying remarks(en)

1.5 Packaging

   1.5.1  Primary Packaging
           1.5.1.17  Other non-sterile medicinal products: multidose powder inhaler(en)
   1.5.2  Secondary packaging

1.6 Quality control testing

1.6.2 Microbiological: non-sterility
1.6.3 Chemical/Physical

2 IMPORTATION OF MEDICINAL PRODUCTS

2.3 Other importation activities

2.3.3 Biological active substance

4. Other Activities - Active Substances:
Physical processing operations (micronisation and conditioning), packaging and quality control testing of active substances to be used for manufacturing of non-sterile human investigational medicinal products in multidose powder inhalers.

Clarifying remarks (for public users):

1.4.3 - Manufacturing covers hormones or substances with hormonal activity. - Manufacturing also includes preparation and spray drying of nonactive substances as porous particles. - Storage of primary and secondary materials is performed at Gärtunavägen, 152 57 Södertälje. 1.5.2 Manufacturing of investigational medicinal products is restricted to open-label packaging only. 1.6 Quality control testing is performed at addresses Forskargatan 18, 151 36 Södertälje and Gärtunavägen, 152 57 Södertälje.

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.