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RTF Template

Ministry Of Social Affairs Health Women And Family

UNION FORMAT FOR A WHOLESALE DISTRIBUTION AUTHORISATION

Human medicinal products

1. Authorisation Number	:	DE_SL_01_WDA_2024_0007/5011-065
2. Name of Authorisation Holder	:	PROLIFE Infusio GmbH (ORG-100048526 / LOC-100080418)
3. Address(es) of Site(s)	:	Industriestrasse 2, Neuweiler, Sulzbach, Saarland, 66280, Germany

4. Legally registered address of Authorisation Holder	:	Industriestrasse 2, Neuweiler, Sulzbach, Saarland, 66280
5. Scope of authorisation (complete for each site under 4)	:	ANNEX 1
6. Legal basis of authorisation	:	Art. 77(1) of Directive 2001/83/EC
7. Name of responsible officer of the competent authority of the member state granting the wholesaling authorisation	:	Confidential, Confidential
8. Signature	:
9. Date	:	2024-06-07
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: PROLIFE Infusio GmbH

(ORG-100048526 / LOC-100080418)

, Industriestrasse 2, Neuweiler, Sulzbach, Saarland, 66280, Germany

Human medicinal products

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): The range of medicines is limited to parenteral nutrition, infusion solutions, disinfectants, medical oxygen and instillagel.

Das Arzneimittelsortiment beschränk sich auf Parenterale Ernährung, Infusionslösungen, Desinfektionsmittel, medizinischen Sauerstoff und Instillagel.

*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_SL_01_WDA_2024_0007/5011-065
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