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RTF Template

Regierungspraesidium Tuebingen Pharmazeutische Angelegenheiten

UNION FORMAT FOR A WHOLESALE DISTRIBUTION AUTHORISATION

Human medicinal products

1. Authorisation Number	:	DE_BW_05_WDA_2023_0005
2. Name of Authorisation Holder	:	Cosmedo GmbH (ORG-100035383 / LOC-100056094)
3. Address(es) of Site(s)	:	Leutkircher Straße 50, Isny, 88316, Germany

4. Legally registered address of Authorisation Holder	:	Leutkircher Strasse 50, Isny Im Allgaeu, Baden-Wuerttemberg, 88316
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	:	2023-05-22
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: Cosmedo GmbH

, Leutkircher Straße 50, Isny, 88316, 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

2.4. Export

3. MEDICINAL PRODUCTS WITH ADDITIONAL REQUIREMENTS

3.1.1. Narcotic or psychotropic products

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): Ref 2.4.: export only within collection by customer.
Ref 3.1.1: preparations according to section 2 subsection 1 no. 3 German Narcotic Drugs Act only for distribution in Germany.
Wholesale distributor comprises the rooms CGH 1, CGH 2, CGH 3, CGH 4, CGH 5 and CGH 6 situated in the address Leutkircher Straße 50 in Isny.
This WDA is based on floor plans provided on 12th of May 2023 (created on 12th of May 2023).

Zu 2.4.: Export nur als Abgabe im Rahmen einer Abholung:
Zu 3.1.1: Nur ausgenommene Zubereitungen nach § 2 Abs. 1 Nr. 3 BtMG für den Verkehr in Deutschland.
Die Großhandelserlaubnis umfasst die Räume CGH 1, CGH 2, CGH 3, CGH 4, CGH 5, CGH 6 und CGH 7 im Gebäude Leutkircher Straße 50 in 88316 Isny.
Die Erlaubnis basiert auf den am 12.05.2023 zur Verfügung gestellten Grundrissplan (Stand: 12.05.2023).

*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_BW_05_WDA_2023_0005
	Page 1

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