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RTF Template


Department of drug and pharmacy supervision

UNION FORMAT FOR A WHOLESALE DISTRIBUTION AUTHORISATION


1. Authorisation Number

:

DE_ST_01_WDA_2018_023

2. Name of Authorisation Holder

:

G.punkt - medical services

3. Address(es) of Site(s)

:

Halberstädter Str. 115 A, Magdeburg, 39112, Germany 




4. Legally registered address of Authorisation Holder

:

Halberstädter Str. 115 A, Magdeburg, 39112, Germany

5. Scope of authorisation

:

ANNEX 1

6. Legal basis of authorisation

:


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

:

Confidential, Confidential

8. Signature

:


9. Date

:

2018-09-05

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: G.punkt - medical services

, Halberstädter Str. 115 A, Magdeburg, 39112, Germany   




1. MEDICINAL PRODUCTS

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


2. AUTHORISED WHOLESALE DISTRIBUTION OPERATIONS

   2.1. Procurement 

   2.2. Holding 

   2.3. Supply 


3. MEDICINAL PRODUCTS WITH ADDITIONAL REQUIREMENTS

   3.2. Medicinal gases 




Any restrictions or clarifying remarks (for all users):  - National legal basis of authorisation:
§ 52a (1) German Drug Law (Arzneimittelgesetz - AMG),
- ref. 1.1 and 3.2: only skin and hand disinfectants and medical oxygen (GOX),
- ref. 2.3: delivery only to doctors and other end-consumers (retail trade),
- wholesale activities in the premises according to the approved site plan dated 04.04.2005.

- Nationale Rechtsgrundlage für die Erlaubnis: § 52a (1) Arzneimittelgesetz (AMG),
- zu 1.1 and 3.2: nur Haut- und Händedesinfektionsmittel sowie medizinischer Sauerstoff (GOX),
- zu 2.3: Abgabe nur an Ärzte und andere Verbraucher (Einzelhandel),
- Großhandel in den Räumen gemäß dem genehmigten Lageplan vom 04.04.2005.















Union Format for a Wholesale Distribution Authorisation

DE_ST_01_WDA_2018_023


Page 1





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