Bulgarian Drug Agency
UNION FORMAT FOR A WHOLESALE DISTRIBUTION AUTHORISATION
1. Authorisation Number
:
BG/WDA/MP-0278
2. Name of Authorisation Holder
ПИНБАУ ЕООД / PINBAU LTD
3. Address(es) of Site(s)
ул. „Юрий Гагарин" № 1, кв. „Изток" /1Yrii Gagarin str., kv. Iztok, гр. Перник /Pernik, 2300, Bulgaria
4. Legally registered address of Authorisation Holder
ул. „Св. Св. Кирил и Методий", бл. 10, ет. 3, ап. 10 /, Sv Sv Kiril i Metodii str., bl. 10, fl. 3, app. 10, гр. Перник /Pernik, 2300, 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
2021-07-06
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: ПИНБАУ ЕООД / PINBAU LTD
, ул. „Юрий Гагарин" № 1, кв. „Изток" /1Yrii Gagarin str., kv. Iztok, гр. Перник /Pernik, 2300, Bulgaria
1.1. with a Marketing Authorisation in EEA country(s)
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
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