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The Certificate has been withdrawn, withdrawn date is : 2025-08-13

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National Authority Of Medicines And Medical Devices Of Romania

CERTIFICATE NUMBER: 049/2025/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: Novartis Pharmaceuticals S.R.L.

Site address:	Strada Livezeni Nr. 7a, Targu Mures, Mures, 540472, Romania
Additional details on units inspected:	*NOVARTIS PHARMACEUTICALS S.R.L., complete address: Str. Livezeni, Nr.7A, Municipiul Târgu Mureş, Județ Mureş, cod poștal 540472, România*

OMS Organisation Id. / OMS Location Id.: ORG-100055120 / LOC-100097871

Has been inspected under the national inspection programme 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 2022-08-26 , 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

1.2 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, powders and granules for oral suspensions(en)
           1.2.1.13  Tablets
   1.2.2  Batch certification

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, powders and granules for oral suspensions(en)
           1.5.1.13  Tablets
   1.5.2  Secondary packaging

1.6 Quality control testing

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

2.1.2 Microbiological: non-sterility
2.1.3 Chemical/Physical

2.2 Batch certification of imported medicinal products

   2.2.1  Sterile products
           2.2.1.2  Terminally sterilised
   2.2.2  Non-sterile products

2.3 Other importation activities

2.3.1 Site of physical importation
2.3.4 Other: release for sale of imported medicinal products(en)

Clarifying remarks (for public users):

total manufacturing operations are carried out for non-sterile products,including antibiotics macrolides and other non-beta-lactam antibiotics,respectively for active substances from other therapeutic classes,as well as onco-pediatric in dedicated rooms;partial manufacturing op–secondary packaging are performed for human medicinal products from Novartis group;storage of finished products is performed also in whs belonging to BIOEEL SRL- Str.Budiului,nr.68,Clădirea C15,Mun.Târgu Mureş,Jud.MS,cod poştal 540390,RO,according to Warehousing and logistic;quality control testing-Novartis central Bld–floor 2,Bld C5-floor 1 and floor 2,and also in Testing Center from Str.Livezeni,Nr.4,Mun.Târgu Mureş,Jud.MS,cod poștal 540472.batch testing,batch certif and batch release are performed for imported human med prod provided in Annex no.8 of Manufacturing Authorization;the import of samples is performed for quality control testing in stability studies.This GMP certificate is valid up to August 2025.

Withdrawal comments in English: correction/replaced

Withdrawal comments in National Language: corectie/inlocuit

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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.