Fri 6 Nov 2026 06:05:41 BST
Search Company
*

Active Substance
New Active Substance
Search Site
--
*

Create Site
--
*
*
*
*
*
*
Update Site
Current data stored in EudraGMDP databaseCurrent data stored in OMS
--
Characters remaining:4000/4000
New Active Substance Importation
Active Substance*
Active Substance (English):
Active Substance (NL):
NCA Reference Key:
3rd Country Manufacturer
3rd Country ManufacturerOMS Location IdentifierOMS Organisation IdentifierLegal AddressNCA Reference KeyConfidentialEditDelete
No records found.

3rd Country Distributor
3rd Country DistributorOMS Location IdentifierOMS Organisation IdentifierLegal AddressNCA Reference KeyConfidentialEditDelete
No records found.

RTF Template


Landesdirektion Sachsen

UNION FORMAT FOR A WHOLESALE DISTRIBUTION AUTHORISATION


1. Authorisation Number

:

DE_SN_01/26-5117/158

2. Name of Authorisation Holder

:

first medical gmbh

3. Address(es) of Site(s)

:

An der Morgensonne 2, Geyer, 09468, Germany 

Falkenbacher Hauptstraße 12c, Wolkenstein OT Falkenbach, 09429, Germany 




4. Legally registered address of Authorisation Holder

:

An der Morgensonne 2, Geyer, 09468, Germany

5. Scope of authorisation (complete for each site under 4)

:

ANNEX 1

6. Legal basis of authorisation

:


7. Name of responsible officer of the competent authority of the member state granting the wholesaling authorisation

:

Confidential, Confidential

8. Signature

:


9. Date

:

2020-02-24

10. Annexes attached

:

Annex 1 Scope of wholesale distribution authorisation

Annex 2 (Optional) Address(es) of contract wholesale distribution sites and their authorisation number

Annex 3 (Optional) Name(s) of responsible person(s)

Annex 4 (Optional) Date of Inspection on which authorisation was granted

Annex 5 (Optional) Additional provisions based on national requirements


ANNEX 1

SCOPE OF WHOLESALE DISTRIBUTION AUTHORISATION



Name and address of the site: first medical gmbh

, An der Morgensonne 2, Geyer, 09468, Germany   




1. MEDICINAL PRODUCTS

   1.1. with a Marketing Authorisation in EEA country(s)


2. AUTHORISED WHOLESALE DISTRIBUTION OPERATIONS

   2.1. Procurement 

   2.3. Supply 

   2.4. Export 



Any restrictions or clarifying remarks (for all users):  This authorisation is limited to infusion solutions intended for the replacement or the correction of body fluid, and disinfectants. It is limited to infusion solutions and disinfectants which do not need to be stored under "cool", "cold" or "freezer" conditions.

Diese Erlaubnis gilt nur für den Großhandel mit Desinfektionsmitteln sowie mit Infusionslösungen, die zum Ersatz oder zur Korrektur von Körperflüssigkeit bestimmt sind. Sie gilt dabei ausschließlich für Desinfektionsmittel und Infusionslösungen, die nicht kühl oder tiefgekühlt zu lagern sind.


Name and address of the site: first medical GmbH

, Falkenbacher Hauptstraße 12c, Wolkenstein OT Falkenbach, 09429, Germany   




1. MEDICINAL PRODUCTS

   1.1. with a Marketing Authorisation in EEA country(s)


2. AUTHORISED WHOLESALE DISTRIBUTION OPERATIONS

   2.2. Holding 

   2.3. Supply 

   2.4. Export 



Any restrictions or clarifying remarks (for all users):  This authorisation is limited to infusion solutions intended for the replacement or the correction of body fluid, and disinfectants. It is limited to infusion solutions and disinfectants which do not need to be stored under "cool", "cold" or "freezer" conditions.

Diese Erlaubnis gilt nur für den Großhandel mit Desinfektionsmitteln sowie mit Infusionslösungen, die zum Ersatz oder zur Korrektur von Körperflüssigkeit bestimmt sind. Sie gilt dabei ausschließlich für Desinfektionsmittel und Infusionslösungen, die nicht kühl oder tiefgekühlt zu lagern sind.



*Art 5 of Directive 2001/83/EC or Art 83 of Regulation EC/726/2004

**Without prejudice to further authorisations as may be required according to national legislation













Union Format for a Wholesale Distribution Authorisation

DE_SN_01/26-5117/158


Page 1





Loading, please wait