Swedish Medical Products Agency
UNION FORMAT FOR A WHOLESALE DISTRIBUTION AUTHORISATION
1. Authorisation Number
:
SE-V-WDA-24-069393
2. Name of Authorisation Holder
Nextmune Scandinavia AB
(ORG-100036927 / LOC-100058340)
3. Address(es) of Site(s)
Snickarvagen 7, Eda, Charlottenberg, 673 32, Sweden
4. Legally registered address of Authorisation Holder
5. Scope of authorisation
ANNEX 1
6. Legal basis of authorisation
Art. 99 of Regulation (EU) 2019/6
7. Name of responsible officer of the competent authority of the member state granting the wholesale distribution authorisation
Confidential, Confidential
8. Signature
9. Date
2024-08-19
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
SCOPE OF WHOLESALE DISTRIBUTION AUTHORISATION
Name and address of the site: Nextmune Scandinavia AB
, Snickarvagen 7, Eda, Charlottenberg, 673 32, Sweden
Veterinary medicinal products
1.2. without a Marketing Authorisation in the EEA and intended for EEA market
2.1. Procurement
2.2. Holding
2.3. Supply
3.1.3. Immunological medicinal products
3.3. Cold chain products(requiring low temperature handling)
Reason for Withdrawing:
Withdrawn 2025-02-15 at company's own request, dnr 5.9.4-2024-112524.
Union Format for a Wholesale Distribution Authorisation
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