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RTF Template


District Government Muenster

UNION FORMAT FOR A WHOLESALE DISTRIBUTION AUTHORISATION

Human medicinal products


1. Authorisation Number

:

DE_NW_05_WDA_2022_0012/24.05.03-256

2. Name of Authorisation Holder

:

PluraFores Pharma GmbH

(ORG-100035067 / LOC-100071538)

3. Address(es) of Site(s)

:

Altenberger Straße 316, Borghorst, Steinfurt, North Rhine-Westphalia, 48565, Germany 




4. Legally registered address of Authorisation Holder

:

Altenberger Straße 316, Borghorst, Steinfurt, North Rhine-Westphalia, 48565

5. Scope of authorisation

:

ANNEX 1

6. Legal basis of authorisation

:

Art. 77(1) of Directive 2001/83/EC

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

:

Confidential, Confidential

8. Signature

:


9. Date

:

2022-06-28

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: PluraFores Pharma GmbH

(ORG-100035067 / LOC-100071538)

, Altenberger Straße 316, Borghorst, Steinfurt, North Rhine-Westphalia, 48565, Germany   



Human medicinal products


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 


3. MEDICINAL PRODUCTS WITH ADDITIONAL REQUIREMENTS

     3.1.3. Immunological medicinal products 

   3.3. Cold chain products(requiring low temperature handling) 




Any restrictions or clarifying remarks (for all users):  Only distribution takes place in the business premises of the permit holder
the medicine. The storage of medicines is only permitted in the Fiege HealthCareLogistics GmbH premises at "Bunsenstraße 23, 59229 Ahlen" and "Hessenweg 6, 48157 Münster" (with our own permission in accordance with Section 52a AMG).

In der Betriebsstätte des Erlaubnisinhabers erfolgt ausschließlich der Vertrieb
der Arzneimittel. Die Lagerung der Arzneimittel ist nur in den Betriebsstätten „Bunsenstraße 23, 59229 Ahlen" und „Hessenweg 6, 48157 Münster" der Fiege HealthCareLogistics GmbH (mit eigener Erlaubnis nach § 52a AMG) zugelassen.















Union Format for a Wholesale Distribution Authorisation

DE_NW_05_WDA_2022_0012/24.05.03-256


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