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BASG - Bundesamt für Sicherheit im Gesundheitswesen

CERTIFICATE NUMBER: 480253-100428019

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
Art. 94(1) of Regulation (EU) 2019/6 as amended

The competent authority of Austria confirms the following:

The manufacturer: Loba Biotech GmbH

Site address:

Markt, Fehrgasse 7, Fischamend, 2401, Austria

OMS Organisation Id. / OMS Location Id.: ORG-100020850 / LOC-100029565

Has been inspected under the national inspection programme in connection with manufacturing authorisation no. 480253 in accordance with Art. 88 of Regulation (EU) 2019/6 and Art. 40 of Directive 2001/83/EC, transposed in the following national legislation:§ 63 Medicines Act (Arzneimittelgesetz) and Ordinance 2009 (Arzneimittelbetriebsordnung 2009).

Is an active substance manufacturer that has been inspected in accordance with Art. 123(6) of Regulation (EU) 2019/6 and Art. 111(1) of Directive 2001/83/EC1 transposed in the following national legislation:§ 63a Medicines Act (Arzneimittelgesetz) and Ordinance 2009 (Arzneimittelbetriebsordnung 2009).

From the knowledge gained during inspection of this manufacturer, the latest of which was conducted on 2022-10-13 , it is considered that it complies with:

The principles and guidelines of Good Manufacturing Practice laid down in Directive (EU) 2017/1572. (3)

The principles and guidelines of Good Manufacturing Practice laid down in Directive 91/412/EEC. (3)

The principles of GMP for active substances referred to in Art. 123(6) of Regulation (EU) 2019/6 and Article 47 of Directive 2001/83/EC and an appropriate level of GMP as referred to in Article 46(f) of Directive 2001/83/EC transposed in the following national legislation:§ 63a Medicines Act (Arzneimittelgesetz) and Ordinance 2009 (Arzneimittelbetriebsordnung 2009).

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/EC and Art. 80(5) of Directive 2001/82/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
Veterinary Medicinal Products

2 IMPORTATION OF MEDICINAL PRODUCTS

2.2 Batch certification of imported medicinal products

   2.2.1  Sterile products
           2.2.1.1  Aseptically prepared
           2.2.1.2  Terminally sterilised
   2.2.2  Non-sterile products
   2.2.3  Biological medicinal products
           2.2.3.5  Biotechnology products

2.3 Other importation activities

2.3.1 Site of physical importation

Manufacture of active substance. Names of substances subject to inspection:

[900000005337]Naphazolin Hydrochlorid / Naphazoline hydrochloride(en)

[900000005338]Naphazolin Nitrat / Naphazoline nitrate(en)

[900000005331]Dexamethason-21-isonicotinat / Dexamethasone-21-isonicotinate(en)

[900000005332]Dihydrocodein Hydrochlorid / Dihydrocodeine hydrochloride(en)

[900000005333]Melarsenoxid / Melarsen oxide(en)

[900000005335]Methantheliniumbromid / Methanthelinium bromide(en)

[900000005336]Nabilon /Nabilone(en)

[900000005342]3,4-Diaminopyridin / 3,4-Diaminopyridine(en)

[900000005340]Tetrabenazin / Tetrabenazine(en)

[900000005334]Melarsomin Dihydrochlorid / Melarsomine dihydrochloride(en)

3. MANUFACTURING OPERATIONS - ACTIVE SUBSTANCES

Active Substance:Naphazolin Hydrochlorid / Naphazoline hydrochloride

3.1 Manufacture of Active Substance by Chemical Synthesis

3.1.1  Manufacture of active substance intermediates

3.1.2  Manufacture of crude active substance

3.1.3  Salt formation / Purification steps:
Extraction, Precipitation, Centrifugation, Recrystallization, Filtration, Drying

3.5 General Finishing Steps

3.5.1  Physical processing steps:
Trocknen, mechanische Aufbereitung / Drying, mechanical processing

3.5.2  Primary Packaging (enclosing / sealing the active substance within a packaging material which is in direct contact with the substance)

3.5.3  Secondary Packaging (placing the sealed primary package within an outer packaging material or container. This also includes any labelling of the material which could be used for identification or traceability (lot numbering) of the active substance)

3.6 Quality Control Testing

3.6.1  Physical / Chemical testing

Active Substance:Naphazolin Nitrat / Naphazoline nitrate

3.1 Manufacture of Active Substance by Chemical Synthesis

3.1.1  Manufacture of active substance intermediates

3.1.2  Manufacture of crude active substance

3.1.3  Salt formation / Purification steps:
Extraction, Precipitation, Centrifugation, Recrystallization, Filtration, Drying

3.5 General Finishing Steps

3.5.1  Physical processing steps:
Trocknen, mechanische Aufbereitung / Drying, mechanical processing

3.5.2  Primary Packaging (enclosing / sealing the active substance within a packaging material which is in direct contact with the substance)

3.5.3  Secondary Packaging (placing the sealed primary package within an outer packaging material or container. This also includes any labelling of the material which could be used for identification or traceability (lot numbering) of the active substance)

3.6 Quality Control Testing

3.6.1  Physical / Chemical testing

Active Substance:Dexamethason-21-isonicotinat / Dexamethasone-21-isonicotinate

3.1 Manufacture of Active Substance by Chemical Synthesis

3.1.1  Manufacture of active substance intermediates

3.1.2  Manufacture of crude active substance

3.1.3  Salt formation / Purification steps:
Extraction, Precipitation, Centrifugation, Recrystallization, Filtration, Drying

3.5 General Finishing Steps

3.5.1  Physical processing steps:
Trocknen, mechanische Aufbereitung / Drying, mechanical processing

3.5.2  Primary Packaging (enclosing / sealing the active substance within a packaging material which is in direct contact with the substance)

3.5.3  Secondary Packaging (placing the sealed primary package within an outer packaging material or container. This also includes any labelling of the material which could be used for identification or traceability (lot numbering) of the active substance)

3.6 Quality Control Testing

3.6.1  Physical / Chemical testing

Active Substance:Dihydrocodein Hydrochlorid / Dihydrocodeine hydrochloride

3.1 Manufacture of Active Substance by Chemical Synthesis

3.1.1  Manufacture of active substance intermediates

3.1.2  Manufacture of crude active substance

3.1.3  Salt formation / Purification steps:
Extraction, Precipitation, Centrifugation, Recrystallization, Filtration, Drying

3.5 General Finishing Steps

3.5.1  Physical processing steps:
Trocknen, mechanische Aufbereitung / Drying, mechanical processing

3.5.2  Primary Packaging (enclosing / sealing the active substance within a packaging material which is in direct contact with the substance)

3.5.3  Secondary Packaging (placing the sealed primary package within an outer packaging material or container. This also includes any labelling of the material which could be used for identification or traceability (lot numbering) of the active substance)

3.6 Quality Control Testing

3.6.1  Physical / Chemical testing

Active Substance:Melarsenoxid / Melarsen oxide

3.1 Manufacture of Active Substance by Chemical Synthesis

3.1.1  Manufacture of active substance intermediates

3.1.2  Manufacture of crude active substance

3.1.3  Salt formation / Purification steps:
Extraction, Precipitation, Centrifugation, Recrystallization, Filtration, Drying

3.5 General Finishing Steps

3.5.1  Physical processing steps:
Trocknen, mechanische Aufbereitung / Drying, mechanical processing

3.5.2  Primary Packaging (enclosing / sealing the active substance within a packaging material which is in direct contact with the substance)

3.5.3  Secondary Packaging (placing the sealed primary package within an outer packaging material or container. This also includes any labelling of the material which could be used for identification or traceability (lot numbering) of the active substance)

3.6 Quality Control Testing

3.6.1  Physical / Chemical testing

Active Substance:Methantheliniumbromid / Methanthelinium bromide

3.1 Manufacture of Active Substance by Chemical Synthesis

3.1.1  Manufacture of active substance intermediates

3.1.2  Manufacture of crude active substance

3.1.3  Salt formation / Purification steps:
Extraction, Precipitation, Centrifugation, Recrystallization, Filtration, Drying

3.5 General Finishing Steps

3.5.1  Physical processing steps:
Trocknen, mechanische Aufbereitung / Drying, mechanical processing

3.5.2  Primary Packaging (enclosing / sealing the active substance within a packaging material which is in direct contact with the substance)

3.5.3  Secondary Packaging (placing the sealed primary package within an outer packaging material or container. This also includes any labelling of the material which could be used for identification or traceability (lot numbering) of the active substance)

3.6 Quality Control Testing

3.6.1  Physical / Chemical testing

Active Substance:Nabilon /Nabilone

3.1 Manufacture of Active Substance by Chemical Synthesis

3.1.1  Manufacture of active substance intermediates

3.1.2  Manufacture of crude active substance

3.1.3  Salt formation / Purification steps:
Extraction, Precipitation, Centrifugation, Recrystallization, Filtration, Drying

3.5 General Finishing Steps

3.5.1  Physical processing steps:
Trocknen, mechanische Aufbereitung / Drying, mechanical processing

3.5.2  Primary Packaging (enclosing / sealing the active substance within a packaging material which is in direct contact with the substance)

3.5.3  Secondary Packaging (placing the sealed primary package within an outer packaging material or container. This also includes any labelling of the material which could be used for identification or traceability (lot numbering) of the active substance)

3.6 Quality Control Testing

3.6.1  Physical / Chemical testing

Active Substance:3,4-Diaminopyridin / 3,4-Diaminopyridine

3.1 Manufacture of Active Substance by Chemical Synthesis

3.1.1  Manufacture of active substance intermediates

3.1.2  Manufacture of crude active substance

3.1.3  Salt formation / Purification steps:
Extraction, Precipitation, Centrifugation, Recrystallization, Filtration, Drying

3.5 General Finishing Steps

3.5.1  Physical processing steps:
Trocknen, mechanische Aufbereitung / Drying, mechanical processing

3.5.2  Primary Packaging (enclosing / sealing the active substance within a packaging material which is in direct contact with the substance)

3.5.3  Secondary Packaging (placing the sealed primary package within an outer packaging material or container. This also includes any labelling of the material which could be used for identification or traceability (lot numbering) of the active substance)

3.6 Quality Control Testing

3.6.1  Physical / Chemical testing

Active Substance:Tetrabenazin / Tetrabenazine

3.1 Manufacture of Active Substance by Chemical Synthesis

3.1.1  Manufacture of active substance intermediates

3.1.2  Manufacture of crude active substance

3.1.3  Salt formation / Purification steps:
Extraction, Precipitation, Centrifugation, Recrystallization, Filtration, Drying

3.5 General Finishing Steps

3.5.1  Physical processing steps:
Trocknen, mechanische Aufbereitung / Drying, mechanical processing

3.5.2  Primary Packaging (enclosing / sealing the active substance within a packaging material which is in direct contact with the substance)

3.5.3  Secondary Packaging (placing the sealed primary package within an outer packaging material or container. This also includes any labelling of the material which could be used for identification or traceability (lot numbering) of the active substance)

3.6 Quality Control Testing

3.6.1  Physical / Chemical testing

Active Substance:Melarsomin Dihydrochlorid / Melarsomine dihydrochloride

3.1 Manufacture of Active Substance by Chemical Synthesis

3.1.1  Manufacture of active substance intermediates

3.1.2  Manufacture of crude active substance

3.1.3  Salt formation / Purification steps:
Extraction, Precipitation, Centrifugation, Recrystallization, Filtration, Drying

3.5 General Finishing Steps

3.5.1  Physical processing steps:
Trocknen, mechanische Aufbereitung / Drying, mechanical processing

3.5.2  Primary Packaging (enclosing / sealing the active substance within a packaging material which is in direct contact with the substance)

3.5.3  Secondary Packaging (placing the sealed primary package within an outer packaging material or container. This also includes any labelling of the material which could be used for identification or traceability (lot numbering) of the active substance)

3.6 Quality Control Testing

3.6.1  Physical / Chemical testing

Clarifying remarks (for public users):

Loba Feinchemie GmbH; Keine / none

Withdrawal comments in English: Superseded because new certificate was issued following an inspection

Withdrawal comments in National Language: Superseded because new certificate was issued following an inspection

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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.