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The Certificate has been withdrawn, withdrawn date is : 2025-05-12

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Health Products Regulatory Authority

CERTIFICATE NUMBER: 34364_M11074/00001

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 Ireland confirms the following:

The manufacturer: MSD INTERNATIONAL GmbH

Site address:	Kilsheelan, Ballydine, Clonmel, E91 V091, Ireland
Additional details on units inspected:	*Company's site address as per OMS database: Ballydine, Kilsheelan, Clonmel, Co Tipperary, E91 V091, Ireland*

OMS Organisation Id. / OMS Location Id.: ORG-100012339 / LOC-100018920

Has been inspected under the national inspection programme in connection with manufacturing authorisation no. M11074/00001 in accordance with Art. 40 of Directive 2001/83/EC, transposed in the following national legislation:Medicinal Products (Control of Manufacture) Regulations 2007 (S.I. No. 539/2007), as amended..

From the knowledge gained during inspection of this manufacturer, the latest of which was conducted on 2022-05-13 , 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)
           1.2.1.13  Tablets
           1.2.1.17  Other: Spray dried intermediate(en)

1.6 Quality control testing

1.6.3 Chemical/Physical

2 IMPORTATION OF MEDICINAL PRODUCTS

2.3 Other importation activities

2.3.2 Importation of intermediate which undergoes further processing

4. Other Activities - Active Substances:
The HPRA does not routinely issue hard copies of GMP certificates. Authenticity of GMP certification may be verified on the EudraGMDP database. The inspection was performed as a hybrid on-site inspection and distant assessment. The distant assessment process included review of documentation and interviews with Subject Matter Experts on a remote platform.

Clarifying remarks (for public users):

1.2.1.13 includes Real Time Release Testing on tablets (assay, identity, disintegration and content uniformity using at line Near Infrared (NIR) analysis). Any real time release testing must also be approved via specific Marketing Authorisation(s) for the product(s) concerned. Activities listed on this certificate were reviewed by distant assessment; an on-site inspection was not conducted.

Withdrawal comments in English: superseded by 35573

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.