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Information Messages

The WDA has been withdrawn, withdrawn date is: 2024-09-16

RTF Template

Bulgarian Drug Agency

UNION FORMAT FOR A WHOLESALE DISTRIBUTION AUTHORISATION

Human medicinal products

1. Authorisation Number	:	BG/WDA/MP-0345
2. Name of Authorisation Holder	:	Akma Finance EOOD (ORG-100036467 / LOC-100057660)
3. Address(es) of Site(s)	:	Manastirski Livadi Zapad, Balgaria No 98 Office 7 Blvd, Sofia, 1618, Bulgaria

4. Legally registered address of Authorisation Holder	:	Manastirski Livadi Zapad, Balgaria No 98 Office 7 Blvd, Sofia, 1618
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	:	2022-07-20
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

ANNEX 1

SCOPE OF WHOLESALE DISTRIBUTION AUTHORISATION

Name and address of the site: Akma Finance EOOD

(ORG-100036467 / LOC-100057660)

, Manastirski Livadi Zapad, Balgaria No 98 Office 7 Blvd, Sofia, 1618, Bulgaria

Human medicinal products

1. MEDICINAL PRODUCTS

1.1. with a Marketing Authorisation in EEA country(s)

2. AUTHORISED WHOLESALE DISTRIBUTION OPERATIONS

2.1. Procurement

2.2. Holding

2.3. Supply

2.4. Export

3. MEDICINAL PRODUCTS WITH ADDITIONAL REQUIREMENTS

3.3. Cold chain products(requiring low temperature handling)

Any restrictions or clarifying remarks (for all users): site address is: Sofia, residential area Krasna polyana, Vuzkresenie blvd., building 132 A, entrence A, but without log number

*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:

3OA-0483/16.09.2024

Union Format for a Wholesale Distribution Authorisation	BG/WDA/MP-0345
	Page 1

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