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The Certificate has been withdrawn, withdrawn date is : 2024-09-24

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National Authority Of Medicines And Medical Devices

CERTIFICATE NUMBER: 012/2024/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: Hemofarm a.d. Vrsac

Site address:

Beogradski Put Bb, Juzno Banatski, Vrsac, 26300, Serbia

OMS Organisation Id. / OMS Location Id.: ORG-100014072 / LOC-100019883

Has been inspected in connection with marketing authorisation(s) listing manufacturers located outside of the European Economic Area in accordance with Art. 111(4) of Directive 2001/83/EC transposed in the following national legislation:art. 857(4) of 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 2022-02-25 , 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

   1.1.1  Aseptically prepared (processing operations for the following dosage forms)
           1.1.1.2  Lyophilisates
           1.1.1.4  Small volume liquids
   1.1.2  Terminally Sterilised (processing operations for the following dosage forms)
           1.1.2.3  Small volume liquids

1.2 Non-sterile products

   1.2.1  Non-sterile products (processing operations for the following dosage forms)
           1.2.1.1  Capsules, hard shell
           1.2.1.8  Other solid dosage forms: film-coated tablets, oral dispersable tablets, gastroresistant tablets, prolonged release tablets(en)
           1.2.1.13  Tablets

1.3 Biological medicinal products (list of product types)

1.3.1 Biological medicinal products (list of product types)
1.3.1.8 Other: biosimilar products(en)

1.5 Packaging

   1.5.1  Primary Packaging
           1.5.1.1  Capsules, hard shell
           1.5.1.8  Other solid dosage forms: film-coated tablets, oral dispersable tablets, gastroresistant tablets, prolonged release tablets(en)
           1.5.1.13  Tablets
   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):

total manufacturing operations are carried out for sterile products in Building PIP and Building PSP; total manufacturing operations are carried out for non-sterile products in Building SDFP and Building PC; this certificate covers also the activities inspected on 27.10.2023 such as adaptation/reconstruction of areas and introduction of new tablet coating device, new compacting device and new sorting machine in Solid Dosage Forms Plant, reconstruction of sampling area in the high rack warehouse and new primary and secondary packaging line in the Packaging Center Vrsac. This Certificate is valid until February 2025.

Withdrawal comments in English: updated/replaced

Withdrawal comments in National Language: actualizat/inlocuit

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.