Bulgarian Drug Agency
UNION FORMAT FOR A WHOLESALE DISTRIBUTION AUTHORISATION
1. Authorisation Number
:
BG/WDA/MP-0288
2. Name of Authorisation Holder
АКСИОН МЕДИКАЛ ЕООД / AXION MEDICAL LTD
3. Address(es) of Site(s)
ул. „Околовръстен път" № 454 Б / 454 B Ring road blvd., гр. София / Sofia, 1000, Bulgaria
4. Legally registered address of Authorisation Holder
район Витоша, бул. „България" № 102, ет. 8, офис № 67 / Vitosha district, 102 Bulgaria blvd., fl. 8, office 67, гр. София / Sofia, 1618, Bulgaria
5. Scope of authorisation (complete for each site under 4)
ANNEX 1
6. Legal basis of authorisation
7. Name of responsible officer of the competent authority of the member state granting the wholesaling authorisation
Confidential, Confidential
8. Signature
9. Date
2021-08-27
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: АКСИОН МЕДИКАЛ ЕООД/ AXION MEDICAL LTD
, ул. „Околовръстен път" № 454 Б / 454 B Ring road blvd., гр. София / Sofia, 1000, Bulgaria
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
3.3. Cold chain products(requiring low temperature handling)
*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
Union Format for a Wholesale Distribution Authorisation
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