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RTF Template

Regierungspraesidium Darmstadt

UNION FORMAT FOR A WHOLESALE DISTRIBUTION AUTHORISATION

Human medicinal products

1. Authorisation Number	:	DE_HE_01_WDA_2023_0035
2. Name of Authorisation Holder	:	Ascend GmbH (ORG-100001817 / LOC-100021511)
3. Address(es) of Site(s)	:	c/o Pollux Business Center GmbH, Sebastian-Kneipp-Straße 41, Frankfurt am Main, Hessen, 60439, Germany

4. Legally registered address of Authorisation Holder	:	Sebastian-Kneipp-Strasse 41, Niederursel, Frankfurt Am Main, 60439
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	:	2023-05-23
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

ANNEX 1

SCOPE OF WHOLESALE DISTRIBUTION AUTHORISATION

Name and address of the site: Ascend GmbH

, c/o Pollux Business Center GmbH, Sebastian-Kneipp-Straße 41, Frankfurt am Main, Hessen, 60439, 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

2.3. Supply

2.5. Other activities(s): holding and supply as an outsourced activity in an external warehouse (see Annex 2)Lagerung und Lieferung (Abgabe) in einem beauftragten Betrieb (Anlage2)

3. MEDICINAL PRODUCTS WITH ADDITIONAL REQUIREMENTS

3.1.1. Narcotic or psychotropic products

Any restrictions or clarifying remarks (for all users): ref 3.1.1: Subject to authorisation according to para 3 German Narcotics Act (Betäubungsmittelgesetz)

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_2023_0035
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