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National Authority Of Medicines And Medical Devices Of Romania

CERTIFICATE NUMBER: 016/2025/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: Aenova Romania S.R.L.

Site address:	Strada Carol I Nr. 20, Cornu, 107175, Romania
Additional details on units inspected:	*complete address: Str. Carol I, nr. 20, Comuna Cornu, Județ Prahova, cod poștal 107180, România*

OMS Organisation Id. / OMS Location Id.: ORG-100054172 / LOC-100095863

Has been inspected under the national inspection programme in connection with manufacturing authorisation no. 19F 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 2024-10-11 , 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)
           1.2.1.2  Capsules, soft shell
   1.2.2  Batch certification

1.5 Packaging

   1.5.1  Primary Packaging
           1.5.1.2  Capsules, soft shell
   1.5.2  Secondary packaging

1.6 Quality control testing

1.6.3 Chemical/Physical

2 IMPORTATION OF MEDICINAL PRODUCTS

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):

total manufacturing operations for non-sterile products - soft gelatin capsules in Step 1 Section, EXTINDERE Section, Step 2 Section; partial manufacturing operations for non-sterile products - soft gelatin capsules in bulk, including bulk testing and bulk certification, also for third parties in Step 1 Section, EXTINDERE Section; partial manufacturing operations - primary and secondary packaging for non-sterile products - soft gelatin capsules, including for third parties are carried out in Step 2 Section; (text missing)storage of bulk product and raw materials is carried out in Building A900 (Step 1 Section); storage of primary and secondary packaging materials is carried out in Building A901 (Step 1 Section); importation of intermediate products from Switzerland (bulk soft capsules), China (Docusate sodium USP 50% PEG 400 NF suspension); storage of intermediate products is carried out in Building A900 (Step 1 Section).This GMP certificate is valid up to October 2027.

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.