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RTF Template


Hessian Office For Health And Care

UNION FORMAT FOR A WHOLESALE DISTRIBUTION AUTHORISATION

Human medicinal products


1. Authorisation Number

:

DE_HE_01_WDA_2022_0039

2. Name of Authorisation Holder

:

Purecan GmbH

(ORG-100046132 / LOC-100076099)

3. Address(es) of Site(s)

:

Reuterweg 76, Westend-Nord, Frankfurt Am Main, 60323, Germany 

Rheinstrasse 34, Darmstadt, 64283, Germany 




4. Legally registered address of Authorisation Holder

:

Reuterweg 76, Westend-Nord, Frankfurt Am Main, 60323, Germany

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

:

ANNEX 1

6. Legal basis of authorisation

:

Sect 52a para 1 German Medicinal Product Act

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

:

Confidential, Confidential

8. Signature

:


9. Date

:

2023-10-06

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: Purecan GmbH

(ORG-100046132 / LOC-100076099)

, Reuterweg 76, Westend-Nord, Frankfurt Am Main, 60323, Germany   



Human medicinal products


1. MEDICINAL PRODUCTS

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

   1.2. without a Marketing Authorisation in the EEA and intended for EEA market


2. AUTHORISED WHOLESALE DISTRIBUTION OPERATIONS

   2.1. Procurement 

   2.3. Supply 

   2.4. Export 

   2.5. Other activities(s): drop shipmentStreckengeschäfte


3. MEDICINAL PRODUCTS WITH ADDITIONAL REQUIREMENTS

     3.1.1. Narcotic or psychotropic products 

     3.1.2. Medicinal products derived from blood 

     3.1.3. Immunological medicinal products 

   3.3. Cold chain products(requiring low temperature handling) 




Any restrictions or clarifying remarks (for all users):  ref 2.5: Supply (only) by drop shipment
ref 3.1.1: Subject to authorisation according to para 3 German Narcotics Act (Betäubungsmittelgesetz)

zu 2.5: Handel erfolgt (teilweise) im Streckengeschäft (Handel ohne Lagerung)
zu 3.1.1: Vorbehaltlich einer entsprechenden Erlaubnis nach § 3 BtMG


Name and address of the site: Purecan GmbH

(ORG-100046132 / LOC-100080367)

, Rheinstrasse 34, Darmstadt, 64283, Germany   



Human medicinal products


1. MEDICINAL PRODUCTS

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

   1.2. without a Marketing Authorisation in the EEA and intended for EEA market


2. AUTHORISED WHOLESALE DISTRIBUTION OPERATIONS

   2.1. Procurement 

   2.2. Holding 

   2.3. Supply 

   2.4. Export 

   2.5. Other activities(s): drop shipmentStreckengeschäfte


3. MEDICINAL PRODUCTS WITH ADDITIONAL REQUIREMENTS

     3.1.1. Narcotic or psychotropic products 

     3.1.2. Medicinal products derived from blood 

     3.1.3. Immunological medicinal products 

   3.3. Cold chain products(requiring low temperature handling) 




Any restrictions or clarifying remarks (for all users):  ref 2.5: Supply (only) by drop shipment
ref 3.1.1: Subject to authorisation according to para 3 German Narcotics Act (Betäubungsmittelgesetz)

zu 2.5: Handel erfolgt (teilweise) im Streckengeschäft (Handel ohne Lagerung)
zu 3.1.1: Vorbehaltlich einer entsprechenden Erlaubnis nach § 3 BtMG



*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_HE_01_WDA_2022_0039


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