Bulgarian Drug Agency
UNION FORMAT FOR A WHOLESALE DISTRIBUTION AUTHORISATION
1. Authorisation Number
:
BG/WDA/MP - 0308
2. Name of Authorisation Holder
„НОВАМЕД ТРЕЙДИНГ" ЕООД / "NOVAMED TRADING" EOOD
3. Address(es) of Site(s)
район Централен, ул. „Филип Македонски" № 37/district Centralen, 37 Filip Makedonski str., гр. Пловдив/ Plovdiv, 4000, Bulgaria
4. Legally registered address of Authorisation Holder
район Централен, ул. „Филип Македонски" № 37/district Centralen, 37 Filip Makedonski str., гр. Пловдив / Plovdiv, 4000, 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
2022-01-24
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: „НОВАМЕД ТРЕЙДИНГ" ЕООД / "NOVAMED TRADING" EOOD
, район Централен, ул. „Филип Македонски" № 37/district Centralen, 37 Filip Makedonski str., гр. Пловдив/ Plovdiv, 4000, 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
3.1.2. Medicinal products derived from blood
3.1.3. Immunological medicinal products
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
Page 1
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