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Information Messages

The WDA has been withdrawn, withdrawn date is: 2026-02-09

RTF Template

Chief Pharmaceutical Inspectorate

UNION FORMAT FOR A WHOLESALE DISTRIBUTION AUTHORISATION

Human medicinal products

1. Authorisation Number	:	NZOH.5100.23.2023.AKE.5
2. Name of Authorisation Holder	:	Lundbeck Poland Sp. z o.o. (ORG-100036605 / LOC-100057856)
3. Address(es) of Site(s)	:	Ul. Kinga C Gillette 1, Lodz, 94-406, Poland

4. Legally registered address of Authorisation Holder	:	Ul. Marszalkowska 142, Warsaw, 00-061
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	:	2024-06-10
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: Lundbeck Poland Sp. z o.o.

(ORG-100036605 / LOC-100080340)

, Ul. Kinga C Gillette 1, Lodz, 94-406, Poland

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): Asortyment ograniczony w zakresie do produktów leczniczych podmiotu odpowiedzialnego lub wytwórcy należącego do grupy kapitałowej H. Lundbeck A/S.

Reason for Withdrawing:

This WDA is no longer valid. It was withdrawn by decision of the competent authority

To zezwolenie nie jest już aktualne. Zostało wycofane decyzją organu kompetentnego.

Union Format for a Wholesale Distribution Authorisation	NZOH.5100.23.2023.AKE.5
	Page 1

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