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RTF Template

Bulgarian Drug Agency

UNION FORMAT FOR A WHOLESALE DISTRIBUTION AUTHORISATION

Human medicinal products

1. Authorisation Number	:	BG/WDA/MP-0581
2. Name of Authorisation Holder	:	Fresenius Medical Care Bulgaria EOOD (ORG-100042115 / LOC-100069479)
3. Address(es) of Site(s)	:	Ulitsa Lyuben Karavelov 26, Fl. 4, Gabrovo, 5308, Bulgaria

4. Legally registered address of Authorisation Holder	:	Ulitsa Lyuben Karavelov 26, Fl. 4, Gabrovo, 5308
5. Scope of authorisation	:	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 wholesale distribution authorisation	:	Confidential, Confidential
8. Signature	:
9. Date	:	2025-07-25
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: Fresenius Medical Care Bulgaria EOOD

(ORG-100042115 / LOC-100069479)

, Ulitsa Lyuben Karavelov 26, Fl. 4, Gabrovo, 5308, Bulgaria

Human medicinal products

1. MEDICINAL PRODUCTS

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

2. AUTHORISED WHOLESALE DISTRIBUTION OPERATIONS

2.1. Procurement

2.2. Holding

2.3. Supply

Any restrictions or clarifying remarks (for all users): There is an authorized site without LOC number with address: 1532 Sofia, 454A Okolovrysten pyt str and authorized activities: 1.1, 2.1, 2.2, 2.3

Union Format for a Wholesale Distribution Authorisation	BG/WDA/MP-0581
	Page 1

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