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The Certificate has been withdrawn, withdrawn date is : 2024-06-18

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Health Products Regulatory Authority

CERTIFICATE NUMBER: 32747/M11296/00001

CERTIFICATE OF GMP COMPLIANCE OF A MANUFACTURER

Part 1

The competent authority of Ireland confirms the following:

The manufacturer: Biomarin International Limited

Site address:

Shanbally, Ringaskiddy, P43 R298, Ireland

OMS Organisation Id. / OMS Location Id.: ORG-100002926 / LOC-100000972

Has been inspected under the national inspection programme in connection with manufacturing authorisation no. M11296/00001 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 2024-02-16 , it is considered that it complies with:

The authenticity of this certificate may be verified in EudraGMDP. If it does not appear, please contact the issuing authority.

Part 2

Human Medicinal Products

1 MANUFACTURING OPERATIONS

1.1 Sterile products

   1.1.1  Aseptically prepared (processing operations for the following dosage forms)
           1.1.1.4  Small volume liquids
   1.1.3  Batch certification

1.2 Non-sterile products

1.2.2 Batch certification

1.3 Biological medicinal products (list of product types)

   1.3.1  Biological medicinal products (list of product types)
           1.3.1.5  Biotechnology products
   1.3.2  Batch Certification (list of product types)
           1.3.2.5  Biotechnology 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

   2.1.2  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
           2.2.1.1  Aseptically prepared
   2.2.2  Non-sterile products
   2.2.3  Biological medicinal products
           2.2.3.4  Gene therapy products
           2.2.3.5  Biotechnology products

2.3 Other importation activities

2.3.2 Importation of intermediate which undergoes further processing

Clarifying remarks (for public users):

1.3.1.5 relates to the manufacture of biological active substance/intermediate and includes the following processing steps: Cell culture, using mammalian cells; isolation and purification of active substance and preparation of low bioburden formulation. Authorised operations include remote batch certification by a Qualified Person when operating within the EEA or Northern Ireland. The HPRA does not routinely issue hard copies of GMP certificates. Authenticity of GMP certification may be verified on the EudraGMDP database.

Withdrawal comments in English: Superseded

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.