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Norwegian Medical Products Agency

CERTIFICATE NUMBER: 21/07443-11

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 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. 13 of Directive 2001/20/EC and Art. 40 of Directive 2001/83/EC, transposed in the following national legislation:Act of 4 December 1992 on Medicinal Products etc. and Act of 4 December 1992 on Medicinal Products etc..

Is an active substance manufacturer that has been inspected in accordance with Art. 111(1) of Directive 2001/83/EC1 transposed in the following national legislation:Act of 4 December 1992 on Medicinal Products etc..

Other

(Human) Art. 13 of Directive 2001/20/EC

Distant Assessment

From the knowledge gained during inspection of this manufacturer, the latest of which was conducted on 2021-04-29 , 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 of GMP for active substances referred to in Article 47 of Directive 2001/83/EC and an appropriate level of GMP as referred to in Article 46(f) of Directive 2001/83/EC transposed in the following national legislation:Act of 4 December 1992 on Medicinal Products etc..

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

1.1 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 | API(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

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

2.2 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

4. Other Activities - Active Substances:
The certificate also includes manufacture of the following Active Pharmaceutical Ingredients that are approved for specific clinical trials: exametazime, SnFP-CT, AH111907 and AH113487.

Clarifying remarks (for public users):

Section 1.4.1.3 covers batch certification and 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 MA | The authorisation covers importation of the following medicinal 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 IMP is section 2.3.2, and covers importation from USA. |Has been inspected in connection with MIA 21/22312-2

Withdrawal comments in English: A new version is submitted.

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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.