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Information Messages

The WDA has been withdrawn, withdrawn date is: 2025-08-20

RTF Template

Swedish Medical Products Agency

UNION FORMAT FOR A WHOLESALE DISTRIBUTION AUTHORISATION

Human medicinal products

1. Authorisation Number	:	SE-H-WDA-24-049867
2. Name of Authorisation Holder	:	The Public Health Agency Of Sweden (ORG-100030675 / LOC-100048274)
3. Address(es) of Site(s)	:	Nobels Vag 18, Solna, 171 65, Sweden
3.a. Additional details on units inspected of site(s) address(es) (optional) (All authorised sites should be listed if not covered by separate authorisations)	:	Folkhälsomyndigheten

4. Legally registered address of Authorisation Holder	:	Nobels Vag 18, Solna, 171 65, Sweden
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	:	2025-02-18
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: The Public Health Agency Of Sweden

(ORG-100030675 / LOC-100048274)

, Nobels Vag 18, Solna, 171 65, Sweden

Additional details on units inspected of site(s) address(es) (optional) (All authorised sites should be listed if not covered by separate authorisations): Folkhälsomyndigheten

Human medicinal products

1. MEDICINAL PRODUCTS

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

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

2. AUTHORISED WHOLESALE DISTRIBUTION OPERATIONS

2.1. Procurement

2.2. Holding

2.3. Supply

2.4. Export

3. MEDICINAL PRODUCTS WITH ADDITIONAL REQUIREMENTS

3.2. Products requiring low temperature handling

3.2.1. Temperatures between 2 to 8 °C

3.2.2. Other temperatures: (please specify) -20 °C

*Art. 5 of Directive 2001/83/EC, Art. 83 of Regulation (EC) 726/2004 and Art. 110 of Regulation 2019/6.

Reason for Withdrawing:

Replaced by authorisation number SE-H-WDA-24-049867, issue date 2025-08-20.

Union Format for a Wholesale Distribution Authorisation	SE-H-WDA-24-049867
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