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RTF Template

RegierRegierungspraesidium Tuebingen - Referat 25: Übrige Pharmazeutische Bereicheungspraesidium Tuebingen - Referat 25: Übrige Pharmazeutische Bereiche

UNION FORMAT FOR A WHOLESALE DISTRIBUTION AUTHORISATION

1. Authorisation Number	:	DE_BW_05_WDA_2019_0019
2. Name of Authorisation Holder	:	Widmann Gase GmbH
3. Address(es) of Site(s)	:	Hermann-Köhl-Straße 37, Dornstadt, 89160, Germany

4. Legally registered address of Authorisation Holder	:	Hermann-Köhl-Straße 37, Dornstadt, 89160, Germany
5. Scope of authorisation (complete for each site under 4)	:	ANNEX 1
6. Legal basis of authorisation	:
7. Name of responsible officer of the competent authority of the member state granting the wholesaling authorisation	:	Confidential, Confidential
8. Signature	:
9. Date	:	2019-10-30
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: Widmann Gase GmbH

, Hermann-Köhl-Straße 37, Dornstadt, 89160, 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): ref. 3.2: the WDA comprises only gases for medicinal use in compressed gas bottles.
This WDA is based on floor plans sent with letter of 21th October 2019 (version 15.10.2019) and comprises the storage rooms Vollgut (storage rooms 47 till 49) and Leergutlager gases, Sperrlager and the adminstration building.

zu 3.2: die Erlaubnis umfasst medizinische Gase in Druckgasflaschen
Diese Erlaubnis basiert auf den am 21.10.2019 übersandten Grundrissplan (Stand: 15.10.2019) und gilt für die Bereiche Vollgut (Lagerbereiche 47 bis 49), das Leergutlager med. Gase, das Sperrlager und das Verwaltungsgebäude.

*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_BW_05_WDA_2019_0019
	Page 1

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