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Norwegian Medical Products Agency

CERTIFICATE NUMBER: 22/24967-26

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
Art. 111(5) of Directive 2001/83/EC as amended
Art. 94(1) of Regulation (EU) 2019/6 as amended

The competent authority of Norway confirms the following:

The manufacturer: HP Halden Pharma AS

Site address:

Svinesundsveien 80, Halden, 1788, Norway

OMS Organisation Id. / OMS Location Id.: ORG-100050645 / LOC-100088470

Has been inspected under the national inspection programme in accordance with Art. 88 of Regulation (EU) 2019/6, Art. 61 of Regulation (EU) No 536/2014 and Art. 40 of Directive 2001/83/EC, transposed in the following national legislation:Act of 4 December 1992 on Medicinal Products etc..

From the knowledge gained during inspection of this manufacturer, the latest of which was conducted on 2022-11-11 , 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)

The principles and guidelines of Good Manufacturing Practice laid down in Directive 91/412/EEC. (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/EC, Art. 111(5) of Directive 2001/83/EC and Art. 80(5) of Directive 2001/82/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
Veterinary Medicinal Products

1 MANUFACTURING OPERATIONS

1.1 Sterile products

   1.1.1  Aseptically prepared (processing operations for the following dosage forms)
           1.1.1.1  Large volume liquids
                  Special Requirements:
                   7  Other: Emulsions for infusion (en)(en)
           1.1.1.4  Small volume liquids
   1.1.2  Terminally Sterilised (processing operations for the following dosage forms)
           1.1.2.1  Large volume liquids
           1.1.2.3  Small volume liquids
   1.1.3  Batch certification

1.2 Non-sterile products

   1.2.1  Non-sterile products (processing operations for the following dosage forms)
           1.2.1.5  Liquids for external use
                  Special Requirements:
                   7  Other: Cutaneous liquids (Human Medicinal Products)(en)(en)
           1.2.1.6  Liquids for internal use
                  Special Requirements:
                   7  Other: Oral solution (Human Investigational Medicinal Products)(en)(en)
           1.2.1.11  Semi-solids
                  Special Requirements:
                   7  Other: Intestinal gel (en)(en)
   1.2.2  Batch certification

1.5 Packaging

   1.5.1  Primary Packaging
           1.5.1.5  Liquids for external use
                  Special Requirements:
                   7  Other: Cutaneous liquids (Human Medicinal Products)(en)(en)
           1.5.1.6  Liquids for internal use
                  Special Requirements:
                   7  Other: Oral solution (Human Investigational Medicinal Products)(en)(en)
           1.5.1.11  Semi-solids
                  Special Requirements:
                   7  Other: Intestinal gel (en)(en)
   1.5.2  Secondary packaging

1.6 Quality control testing

   1.6.1  Microbiological: sterility
   1.6.2  Microbiological: non-sterility
   1.6.3  Chemical/Physical
   1.6.4  Biological

Clarifying remarks (for public users):

Section 1.6.4 applies to endotoxin testing. This certificate is based on the inspection of the company Fresenius Kabi Norge AS and in accordance with MIA no. 21/31980-2 / authorisation no, 9016-1. A change of name of this company to the above indicated is approved from 1 March 2024 and the new authorisation no. is 9777-1. Inspection result is not influenced by the change of name of the manufacturer or change of authorisation number.

Withdrawal comments in English: Replaced by updated version.

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.