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RTF Template

Chief Pharmaceutical Inspectorate

UNION FORMAT FOR A WHOLESALE DISTRIBUTION AUTHORISATION

Human medicinal products

1. Authorisation Number	:	NOH.5100.62.2018.1122.MG.3
2. Name of Authorisation Holder	:	CSL Behring Sp. z o.o. (ORG-100035223 / LOC-100055871)
3. Address(es) of Site(s)	:	Południowa 2, Ołtarzew, mazowieckie, 05-850, Poland

4. Legally registered address of Authorisation Holder	:	Ul. Adama Branickiego 17, Warsaw, 02-972, Poland
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	:	2024-09-27
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: Hurtownia farmaceutyczna

, Południowa 2, Ołtarzew, mazowieckie, 05-850, Poland

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

3.1.2. Medicinal products derived from blood

3.1.3. Immunological medicinal products

3.3. Cold chain products(requiring low temperature handling)

Any restrictions or clarifying remarks (for all users): Ograniczony asortyment do trzech podmiotów odpowiedzialnych:
CSL Behring GmbH
Adres:
Emil von Behring Strasse 76; 35041 Marburg, Niemcy
Vifor Fresenius Medical Care Renal Pharma France
Adres:
100-101 Terrasse Boieldieu
Tour Franklin La Défense 8
F-92042 Paris La Défense Cedex, Francja
Vifor France
Adres:
100-101 Terrasse Boieldieu
Tour Franklin La Défense 8
F-92042 Paris La Défense Cedex, Francja

*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	NOH.5100.62.2018.1122.MG.3
	Page 1

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