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Norwegian Medical Products Agency

CERTIFICATE NUMBER: 23/18375-12

CERTIFICATE OF GMP COMPLIANCE OF A MANUFACTURER

Part 1

The competent authority of NORWAY confirms the following:

The manufacturer: GE Healthcare AS

Site address:

Nycoveien 1, Oslo, 0485, Norway

OMS Organisation Id. / OMS Location Id.: ORG-100004019 / LOC-100000539

Has been inspected under the national inspection programme in accordance with 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..

Other

(Human) Art. 61 of Regulation (EU) No 536/2014

From the knowledge gained during inspection of this manufacturer, the latest of which was conducted on 2023-09-08 , 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

   1.1.1  Aseptically prepared (processing operations for the following dosage forms)
           1.1.1.2  Lyophilisates
           1.1.1.4  Small volume liquids
                  Special Requirements:
                   7  Other: Parenteral use(en)
           1.1.1.6  Other: Evacuated and gas filled vials(en)
   1.1.2  Terminally Sterilised (processing operations for the following dosage forms)
           1.1.2.1  Large volume liquids
                  Special Requirements:
                   7  Other: Parenteral use(en)
           1.1.2.3  Small volume liquids
                  Special Requirements:
                   7  Other: Parenteral use(en)
   1.1.3  Batch certification

1.4 Other products or manufacturing activity

1.4.1 Manufacture of
1.4.1.3 Other: Reagent kits for manufacture of PET products(en)

1.5 Packaging

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

2 IMPORTATION OF MEDICINAL PRODUCTS

2.1 Quality control testing of imported medicinal products

   2.1.1  Microbiological: sterility
   2.1.2  Microbiological: non-sterility
   2.1.3  Chemical/Physical
   2.1.4  Biological

2.2 Batch certification of imported medicinal products

   2.2.1  Sterile products
           2.2.1.1  Aseptically prepared
           2.2.1.2  Terminally sterilised

2.3 Other importation activities

2.3.1 Site of physical importation
2.3.2 Importation of intermediate which undergoes further processing

Clarifying remarks (for public users):

Section 1.1.2 includes parametric release in manufacture of Omnipaque, Visipaque, Omniscan and Clariscan in glass vials, Omnipaque and Clariscan in polypropylene bottles and Omniscan and Clariscan in prefilled syringes, but only where parametric release is approved under the specific product marketing authorisation. Section 1.4.1.3 covers batch certification. | The authorisation covers importation of the following products from the USA and Canada: Pre-Filled Normal Saline Flush Syringe 0.9 % Sodium Chloride Injection USP, Sodium Phosphate Buffered Solution 0.003 M inj., and Methylene Blue Inj. 1 % USP | The authorisation covers importation of the following products from China: Clariscan 367,9 mg/ml, Omnipaque (240, 300 and 350 mg I/ml), Accupaque (240, 300 and 350 mg I/ml) and Visipaque (270 and 320 mg I/ml) in glass vials or in polypropylene bottles. | The importation activity which applies to Human Investigational Medicinal Products is section 2.3.2, and covers importation from USA.

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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.