Eudra GMP - Public Layout

MIA | GMP | API REG | WDA | GDP | Sites

Help

Tue 10 Nov 2026 13:44:08 BST

GMP Compliance Menu

GMP Certificates

Non-Compliance Report

The Certificate has been withdrawn, withdrawn date is : 2026-01-21

Print Preview

Print Preview (Short version)

Back To Search

Landesamt Fuer Soziale Dienste Schleswig Holstein

CERTIFICATE NUMBER: DE_SH_01_GMP_2024_0041

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 Germany confirms the following:

The manufacturer: Almirall Hermal GmbH

Site address:

Scholtzstrasse 3, Reinbek, Schleswig-Holstein, 21465

OMS Organisation Id. / OMS Location Id.: ORG-100002204 / LOC-100001397

Has been inspected under the national inspection programme in connection with manufacturing authorisation no. DE_SH_01_MIA_2023_0001 in accordance with Art. 40 of Directive 2001/83/EC, transposed in the following national legislation:Sect. 13 para 1 German Medicinal Product Act (manufacture) and § 72 German Medicinal Product Act (import).

From the knowledge gained during inspection of this manufacturer, the latest of which was conducted on 2024-05-30 , 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)
           1.2.1.5  Liquids for external use
                  Special Requirements:
                   7  Other: Hormones/substances with hormonal activity Cytotoxics/cytostatics, genotoxics or teratogens(en)
           1.2.1.6  Liquids for internal use
           1.2.1.11  Semi-solids
                  Special Requirements:
                   7  Other: - Cytotoxics/cytostatics - Medicinal products containing genotoxics or teratogens(en)
   1.2.2  Batch certification

1.4 Other products or manufacturing activity

   1.4.1  Manufacture of
           1.4.1.1  Herbal products
   1.4.3  Other: Only Batch certification - Capsules, hard shell - Capsules, soft shell (soft gelatine capsules containing isotretinoin) - Other solid dosage forms (dragees, powder with solvent for preparation) - Pressurised preparations - Tablets (also film-coated tablets)(en)

1.5 Packaging

   1.5.1  Primary Packaging
           1.5.1.5  Liquids for external use
           1.5.1.6  Liquids for internal use
           1.5.1.11  Semi-solids
   1.5.2  Secondary packaging

1.6 Quality control testing

   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

2.2.2 Non-sterile 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):

To 1.2.1.11 Semi-solids - For oral use as well (mouth gel) To 2.2.2 Non-sterile products - Capsules, hard shell - Capsules, soft Shell (soft Gelatine capsules containing isotretinoin) - Other solid dosage forms (powder with solvent for preparation) - Pressurised preparations - Tablets (also film-coated tablets) - Semi-solid dosage forms (ointments) To 2.3.2 Importation of intermediate which undergoes further processing - Intermediate (soft gelatine capsules containing isotretinoin) - Intermediate (primary packaging ointments) - Intermediate (primary packaging solutions) Parts of the Manufacturing site are situated in Scholtzstrasse 1, 21465 Reinbek

Withdrawal comments in English: GMP certificate has been superseded by document with the number DE_SH_01_GMP_2026_0009

Withdrawal comments in National Language: Das GMP-Zertifikat wurde ersetzt durch das Dokument mit der Nummer DE_SH_01_GMP_2026_0009

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.