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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_2025-0006-01
2. Name of Authorisation Holder	:	Orifarm Trading GmbH & Co. KG (ORG-100039777 / LOC-100081354)
3. Address(es) of Site(s)	:	Fixheider Strasse 4, Quettingen, Leverkusen, 51381, Germany Daimlerstrasse 8, Quettingen, Leverkusen, 51381, Germany

4. Legally registered address of Authorisation Holder	:	Fixheider Strasse 4, Quettingen, Leverkusen, 51381
5. Scope of authorisation	:	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 wholesale distribution authorisation	:	Confidential, Confidential
8. Signature	:
9. Date	:	2025-02-19
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: Orifarm Trading GmbH & Co. KG

(ORG-100039777 / LOC-100081354)

, Fixheider Strasse 4, Quettingen, Leverkusen, 51381, Germany

Human medicinal products

1. MEDICINAL PRODUCTS

1.1. with a Marketing Authorisation or registration in EEA country(s)

1.2. without a Marketing Authorisation or registration in the EEA and intended for EEA market*

1.3. without a Marketing Authorisation or registration in the EEA and intended for exportation

2. AUTHORISED WHOLESALE DISTRIBUTION OPERATIONS

2.1. Procurement

2.2. Holding

2.3. Supply

2.4. Export

3. MEDICINAL PRODUCTS WITH ADDITIONAL REQUIREMENTS

3.1. Narcotic or psychotropic products**

3.2. Products requiring low temperature handling

3.2.2. Other temperatures: (please specify) immunological drugs, medicines made from blood

Any restrictions or clarifying remarks (for all users): Regarding 3.1.1. Subject to a corresponding permit pursuant to Section 3 of the German Narcotics Act (BtMG)

Zu 3.1.1. Vorbehaltlich einer entsprechenden Erlaubnis nach §3 BtMG

Name and address of the site: Orifarm Trading GmbH & Co. KG

(ORG-100039777 / LOC-100063460)

, Daimlerstrasse 8, Quettingen, Leverkusen, 51381, Germany

Human medicinal products

1. MEDICINAL PRODUCTS

1.1. with a Marketing Authorisation or registration in EEA country(s)

1.2. without a Marketing Authorisation or registration in the EEA and intended for EEA market*

1.3. without a Marketing Authorisation or registration in the EEA and intended for exportation

2. AUTHORISED WHOLESALE DISTRIBUTION OPERATIONS

2.1. Procurement

2.2. Holding

2.3. Supply

2.4. Export

3. MEDICINAL PRODUCTS WITH ADDITIONAL REQUIREMENTS

3.1. Narcotic or psychotropic products**

3.2. Products requiring low temperature handling

3.3. Other products: (please specify here or make a reference to Annex 5) immunological drugs, medicines made from blood

Any restrictions or clarifying remarks (for all users): Regarding 3.1.1. Subject to a corresponding permit pursuant to Section 3 of the German Narcotics Act (BtMG)

Zu 3.1.1. Vorbehaltlich einer entsprechenden Erlaubnis nach §3 BtMG

*Art. 5 of Directive 2001/83/EC, Art. 83 of Regulation (EC) 726/2004 and Art. 110 of Regulation 2019/6.

**Without prejudice to further authorisations as may be required according to national legislation.

Union Format for a Wholesale Distribution Authorisation	DE_NW_04_WDA_2025-0006-01
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