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RTF Template

Regierungspraesidium Tuebingen

UNION FORMAT FOR A WHOLESALE DISTRIBUTION AUTHORISATION

Human medicinal products and Veterinary medicinal products

1. Authorisation Number	:	DE_BW_01_WDA_2025_0002_Komtur
2. Name of Authorisation Holder	:	Komtur Pharmaceuticals e.K. (ORG-100014808 / LOC-100023376)
3. Address(es) of Site(s)	:	Am Flughafen 6, Bruehl, Freiburg Im Breisgau, Baden-Wuerttemberg, 79108, Germany

4. Legally registered address of Authorisation Holder	:	Am Flughafen 6, Bruehl, Freiburg Im Breisgau, Baden-Wuerttemberg, 79108, Germany
5. Scope of authorisation	:	ANNEX 1
6. Legal basis of authorisation	:	Art. 77(1) of Directive 2001/83/EC Art. 99 of Regulation (EU) 2019/6
7. Name of responsible officer of the competent authority of the member state granting the wholesale distribution authorisation	:	Confidential, Confidential
8. Signature	:
9. Date	:	2025-03-11
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: Komtur Pharmaceuticals e.K.

(ORG-100014808 / LOC-100023376)

, Am Flughafen 6, Bruehl, Freiburg Im Breisgau, Baden-Wuerttemberg, 79108, Germany

Human medicinal products

Veterinary 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

2.5. Other activities(s): (please specify) Import AMG §73 (2) N.2, §73 (2) Nr.2a, §73 (3) EEA and Non-EEA and §73 (3b) from EEA;Einfuhr nach AMG §73 (2) N.2, §73 (2) Nr.2a, §73 (3) EWR und Nicht-EWR and §73 (3b) aus EWR

3. MEDICINAL PRODUCTS WITH ADDITIONAL REQUIREMENTS

3.1. Narcotic or psychotropic products**

3.2. Products requiring low temperature handling

*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_BW_01_WDA_2025_0002_Komtur
	Page 1

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