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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-0614
2. Name of Authorisation Holder	:	Top Hospital Service AD (ORG-100025754 / LOC-100098825)
3. Address(es) of Site(s)	:	Ulitsa Byalo Pole 16a, Sofiya, Oblast Sofiya Grad, 1618, Bulgaria

4. Legally registered address of Authorisation Holder	:	Ulitsa Byalo Pole 16a, Sofiya, Oblast Sofiya Grad, 1618
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	:	2025-12-16
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: Top Hospital Service AD

(ORG-100025754 / LOC-100098825)

, Ulitsa Byalo Pole 16a, Sofiya, Oblast Sofiya Grad, 1618, 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

2.4. Export

3. MEDICINAL PRODUCTS WITH ADDITIONAL REQUIREMENTS

3.2. Products requiring low temperature handling

3.2.1. Temperatures between 2 to 8 °C

3.2.2. Other temperatures: (please specify) 15°C - 25°C

3.3. Other products: (please specify here or make a reference to Annex 5) Medicinal products derived from blood and immunological medicinal products

Any restrictions or clarifying remarks (for all users): The second authorized site without LOC number with address: 1592 Sofia, district Iskar, 16 Nedelcho Bonchev str. and authorized activities: 1.1, 2.1, 2.2, 2.3, 2.4, 3.2.1, 3.2.2., 3.3.1, 3.3.2 - Medicinal products derived from blood and immunological medicinal products

Union Format for a Wholesale Distribution Authorisation	BG/WDA/MP-0614
	Page 1

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