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RTF Template

Bezirksregierung Koeln

UNION FORMAT FOR A WHOLESALE DISTRIBUTION AUTHORISATION

Human medicinal products

1. Authorisation Number	:	DE_NW_04_WDA_2024-0042-03
2. Name of Authorisation Holder	:	Pfm Medical GmbH (ORG-100050735 / LOC-100088649)
3. Address(es) of Site(s)	:	Wankelstrasse 60, Hahnwald, Cologne, North Rhine-Westphalia, 50996, Germany Urfelder Strasse 69, Urfeld, Wesseling, North Rhine-Westphalia, 50389, Germany

4. Legally registered address of Authorisation Holder	:	Wankelstrasse 60, Hahnwald, Cologne, North Rhine-Westphalia, 50996
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	:	2024-01-12
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: Pfm Medical GmbH

(ORG-100050735 / LOC-100088649)

, Wankelstrasse 60, Hahnwald, Cologne, North Rhine-Westphalia, 50996, 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

3.1.2. Medicinal products derived from blood

3.3. Cold chain products(requiring low temperature handling)

Any restrictions or clarifying remarks (for all users): no

Keine

Name and address of the site: Pfm Medical GmbH

(ORG-100050735 / LOC-100090366)

, Urfelder Strasse 69, Urfeld, Wesseling, North Rhine-Westphalia, 50389, 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

3.1.2. Medicinal products derived from blood

3.3. Cold chain products(requiring low temperature handling)

Any restrictions or clarifying remarks (for all users): no

keine

*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_NW_04_WDA_2024-0042-03
	Page 1

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