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RTF Template

Regional Council Darmstadt

UNION FORMAT FOR A WHOLESALE DISTRIBUTION AUTHORISATION

1. Authorisation Number	:	DE_HE_01_WDA_2021_0013
2. Name of Authorisation Holder	:	WMG Pharma GmbH
3. Address(es) of Site(s)	:	Hessenring 15c, Mörfelden-Walldorf, 64546, Germany

4. Legally registered address of Authorisation Holder	:	Hessenring 15c, Mörfelden-Walldorf, 64546, 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	:	2021-03-24
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: WMG Pharma GmbH

, Hessenring 15c, Mörfelden-Walldorf, 64546, Germany

1. MEDICINAL PRODUCTS

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

2.5. Other activities(s): decanting, packaging or labelling of medicinal products without altering themUmfüllen, Abpacken und Kennzeichnen von Arzneimitteln in unveränderter Form

3. MEDICINAL PRODUCTS WITH ADDITIONAL REQUIREMENTS

3.1.1. Narcotic or psychotropic products

Union Format for a Wholesale Distribution Authorisation	DE_HE_01_WDA_2021_0013
	Page 1

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