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RTF Template


Hessian Office For Health And Care

UNION FORMAT FOR A WHOLESALE DISTRIBUTION AUTHORISATION

Human medicinal products


1. Authorisation Number

:

DE_HE_01_WDA_2025_0015

2. Name of Authorisation Holder

:

Lilly Deutschland GmbH

(ORG-100002505 / LOC-100001395)

3. Address(es) of Site(s)

:

Werner-Reimers-Strasse 2-4, Bad Homburg, 61352, Germany 




4. Legally registered address of Authorisation Holder

:

Werner-Reimers-Strasse 2-4, Bad Homburg, 61352

5. Scope of authorisation

:

ANNEX 1

6. Legal basis of authorisation

:

Sect 52a para 1 German Medicinal Product Act

7. Name of responsible officer of the competent authority of the member state granting the wholesale distribution authorisation

:

Confidential, Confidential

8. Signature

:


9. Date

:

2025-10-01

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: Lilly Deutschland GmbH

(ORG-100002505 / LOC-100001395)

, Werner-Reimers-Strasse 2-4, Bad Homburg, 61352, Germany   



Human medicinal products


1. MEDICINAL PRODUCTS

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


2. AUTHORISED WHOLESALE DISTRIBUTION OPERATIONS

   2.1. Procurement 

   2.3. Supply 

   2.5. Other activities(s): (please specify) holding and supply as an outsourced activity in an external warehouse (see Annex 2)Lagerung und Lieferung (Abgabe) in einem beauftragten Betrieb (Anlage 2)


3. MEDICINAL PRODUCTS WITH ADDITIONAL REQUIREMENTS

   3.1. Narcotic or psychotropic products** 




Any restrictions or clarifying remarks (for all users):  3.1.3 Immunological medicinal products
3.1.4 Radiopharmaceuticals (including radionuclide kits); supply only by drop shipment
3.3 Cold chain products (requiring low temperature handling)

3.1.3 immunologische Arzneimittel
3.1.4 radioaktive Arzneimittel (einschließlich Radionuklidkits); Handel erfolgt im Streckengeschäft (Handel ohne Lagerung).
3.3 Kühlkettenpflichtige Arzneimittel (Lagerung und Transport bei niedrigen Temperaturen)



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













Union Format for a Wholesale Distribution Authorisation

DE_HE_01_WDA_2025_0015


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