1. Authorisation Number

:

DE_RP_01_WDA_2017_54.1/49/138-009

2. Name of Authorisation Holder

:

TOPMED Medical Products GmbH & Co.KG

3. Address(es) of Site(s)

:

In der Langfuhr 26, Bendorf, 56170, Germany 

4. Legally registered address of Authorisation Holder

:

In der Langfuhr 26, Bendorf, 56170, 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

:

2017-11-23

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

Name and address of the site: TOPMED Medical Products GmbH & Co.KG

, In der Langfuhr 26, Bendorf, 56170, Germany   

Any restrictions or clarifying remarks (for all users):  The authorisation is limited to the wholesale activities with
- skin and hand disinfectants
- infusion solutions according to § 47 paragraph 1 No. 2 AMG (German Drug Law).

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Restrictions or remarks (in National Language):

Die Erlaubnis ist beschränkt auf den Großhandel mit folgenden Produkten:
- Haut- und Händedesinfektionsmitteln
- Infusionslösungen gemäß § 47 Abs. 1 Nr. 2 AMG

*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_RP_01_WDA_2017_54.1/49/138-009

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