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The Certificate has been withdrawn, withdrawn date is : 2026-05-25

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National Authority Of Medicines And Medical Devices Of Romania

CERTIFICATE NUMBER: 067/2026/RO

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

The competent authority of Romania confirms the following:

The manufacturer: Infomed Fluids S.R.L.

Site address:	Bulevardul Pallady Theodor Nr 50, Bucharest, 032266, Romania
Additional details on units inspected:	*complete address: Bulevardul Theodor Pallady, nr. 50, Sectorul 3, Bucureşti, cod poștal 032266, România*

OMS Organisation Id. / OMS Location Id.: ORG-100001317 / LOC-100002145

Has been inspected under the national inspection programme in connection with manufacturing authorisation no. 21F in accordance with Art. 40 of Directive 2001/83/EC, transposed in the following national legislation:art. 755 from Law no. 95/2006 regarding the reform in the field of health republished, Title XVIII, Medicinal product.

From the knowledge gained during inspection of this manufacturer, the latest of which was conducted on 2026-05-18 , it is considered that it complies with:

The principles and guidelines of Good Manufacturing Practice laid down in Directive (EU) 2017/1572. (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. 111(5) of Directive 2001/83/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

1 MANUFACTURING OPERATIONS

1.1 Sterile products

   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

1.3 Biological medicinal products (list of product types)

   1.3.1  Biological medicinal products (list of product types)
           1.3.1.6  Human or animal extracted products
   1.3.2  Batch Certification (list of product types)
           1.3.2.6  Human or animal extracted products

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
2.2.1.2 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):

Building A2 - total manufacturing for human medicinal products – sterile products – terminally sterilised - large volumes liquids – packaged in PVC/non PVC bags (volumes from 20 to 5000 ml); Building A2 – total manufacturing, secondary packaging, batch certification of Heparin in 0.9% NaCl Injection 1000 IU/500 ml (2 IU/ml) and Heparin in 0.9% NaCl Injection 2000 IU/1000 ml (2 IU/ml), registered as biological medicinal products in Canada and intended for the Canadian market; (missing text) importation is carried out for manufactured human medicinal products, including the bulk phase of vials, from InfoRLife SA, Switzerland, respectively Infomed Pharma S.A., Tunisia, for batch certification, storage and wholesale distribution; batch testing is performed in Switzerland, Romania. This Certificate is valid up to March 2029.

Withdrawal comments in English: correction/replaced

Withdrawal comments in National Language: corectie/inlocuit

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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.