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RTF Template

Landesverwaltungsamt Sachsen-Anhalt

UNION FORMAT FOR A WHOLESALE DISTRIBUTION AUTHORISATION

Human medicinal products

1. Authorisation Number	:	DE_ST_01_WDA_2024_001
2. Name of Authorisation Holder	:	IDT Biologika GmbH (ORG-100006851 / LOC-100010488)
3. Address(es) of Site(s)	:	Am Pharmapark, Rodleben, Dessau Rosslau, 06861, Germany

4. Legally registered address of Authorisation Holder	:	Am Pharmapark, Rodleben, Dessau Rosslau, 06861
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	:	2024-02-20
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: IDT Biologika GmbH

(ORG-100006851 / LOC-100010488)

, Am Pharmapark, Rodleben, Dessau Rosslau, 06861, 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

3.3. Cold chain products(requiring low temperature handling)

Any restrictions or clarifying remarks (for all users): National legal basis of the authorisation: Section 52a subsection 1 Medicinal Products Act (AMG)
This WDA is based on the confirmed floor plans dated 20/12/2022.

Nationale Rechtsgrundlage der Erlaubnis: § 52a Abs. 1 Arzneimittelgesetz (AMG)
Die Erlaubnis basiert auf den bestätigten Grundrissplänen vom 20.12.2022.

*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_ST_01_WDA_2024_001
	Page 1

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