State Agency of Medicines
UNION FORMAT FOR A WHOLESALE DISTRIBUTION AUTHORISATION
1. Authorisation Number
:
327
2. Name of Authorisation Holder
Dimedium AS/Ltd
3. Address(es) of Site(s)
Roheline 8, Tähtvere village, Tähtvere rural municipality, Tartu county, 61410, Estonia
4. Legally registered address of Authorisation Holder
Emajõe 1a, Tartu, 51008, Estonia
5. Scope of authorisation
ANNEX 1
6. Legal basis of authorisation
7. Name of responsible officer of the competent authority of the member state granting the wholesale distribution authorisation
Confidential, Confidential
8. Signature
9. Date
2016-04-08
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: Dimedium
, Roheline 8, Tähtvere village, Tähtvere rural municipality, Tartu county, 61410, Estonia
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
3.1.1. Narcotic or psychotropic products
3.1.3. Immunological medicinal products
3.3. Cold chain products(requiring low temperature handling)
Union Format for a Wholesale Distribution Authorisation
Page 1
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