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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_2020_0002
2. Name of Authorisation Holder	:	Promed Bubser GmbH
3. Address(es) of Site(s)	:	Mooswiesen 19, Ravensburg, 88214, Germany

4. Legally registered address of Authorisation Holder	:	Mooswiesen 19, Ravensburg, 88214, 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	:	2020-03-17
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: Promed Bubser GmbH

, Mooswiesen 19, Ravensburg, 88214, 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

2.4. Export

3. MEDICINAL PRODUCTS WITH ADDITIONAL REQUIREMENTS

3.2. Medicinal gases

Any restrictions or clarifying remarks (for all users): ref. 1.1.: infusion solutions, X-ray contrast solutions and skin- and handdisinfectants
ref. 2.3.: supply partially by drop shipment
ref. 3.2.: oxygen for medicinal use in compressed pressure gas cylinders

zu 1.1.: Infusionslösungen, Röntgenkontrastmittel sowie Haut- und Händedesinfektionsmittel
zu 2.3.: Handel erfolgt (teilweise) im Streckengeschäft (Handel ohne Lagerung)
zu 3.2.: medizinischer Sauerstoff in Druckgasflaschen

*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_2020_0002
	Page 1

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