State Agency Of Medicines
UNION FORMAT FOR A WHOLESALE DISTRIBUTION AUTHORISATION
1. Authorisation Number
:
88
2. Name of Authorisation Holder
Aconit OÜ
(ORG-100024778 / LOC-100034040)
3. Address(es) of Site(s)
Voru Tn 11, Lasnamae Linnaosa, Tallinn, 13612, Estonia
4. Legally registered address of Authorisation Holder
5. Scope of authorisation (complete for each site under 4)
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 wholesaling authorisation
Confidential, Confidential
8. Signature
9. Date
2024-09-24
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: Aconit OÜ
, Voru Tn 11, Lasnamae Linnaosa, Tallinn, 13612, Estonia
Human 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
1.3. without a Marketing Authorisation in the EEA and intended for exportation
2.1. Procurement
2.2. Holding
2.3. Supply
2.4. Export
*Art 5 of Directive 2001/83/EC or Art 83 of Regulation EC/726/2004
**Without prejudice to further authorisations as may be required according to national legislation
Reason for Withdrawing:
Withdrawn due to incorrectly ticked boxes (1.2 and 1.3), that are corrected now on the new version.
Union Format for a Wholesale Distribution Authorisation
Page 1
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