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Information Messages

The WDA has been withdrawn, withdrawn date is: 2025-01-15

RTF Template

Swedish Medical Products Agency

UNION FORMAT FOR A WHOLESALE DISTRIBUTION AUTHORISATION

Human medicinal products

1. Authorisation Number	:	5.9.4-2023-087577
2. Name of Authorisation Holder	:	Newbury Pharmaceuticals AB (ORG-100031686 / LOC-100049627)
3. Address(es) of Site(s)	:	Medicon Village, Scheele Torget 1, Lund, 223 81, Sweden

4. Legally registered address of Authorisation Holder	:	Medicon Village, Scheele Torget 1, Lund, 223 81
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	:	2023-10-16
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: Newbury Pharmaceuticals AB

(ORG-100031686 / LOC-100049627)

, Medicon Village, Scheele Torget 1, Lund, 223 81, Sweden

Human medicinal products

1. MEDICINAL PRODUCTS

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

1.2. without a Marketing Authorisation in the EEA and intended for EEA market

2. AUTHORISED WHOLESALE DISTRIBUTION OPERATIONS

2.1. Procurement

2.3. Supply

3. MEDICINAL PRODUCTS WITH ADDITIONAL REQUIREMENTS

3.3. Cold chain products(requiring low temperature handling)

Reason for Withdrawing:

Replaced by authorisation number SE-H-WDA-25-003425, issue 2025-01-15.

Union Format for a Wholesale Distribution Authorisation	5.9.4-2023-087577
	Page 1

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