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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-0536
2. Name of Authorisation Holder	:	Santis Medical Solutions EOOD (ORG-100053671 / LOC-100094918)
3. Address(es) of Site(s)	:	Bulevard Nikola Yonkov Vaptsarov 53 Fl. 3, Sofia, 1407, Bulgaria

4. Legally registered address of Authorisation Holder	:	Bulevard Nikola Yonkov Vaptsarov 53 Fl. 3, Sofia, 1407, Bulgaria
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	:	2025-01-16
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: Santis Medical Solutions EOOD

(ORG-100053671 / LOC-100094918)

, Bulevard Nikola Yonkov Vaptsarov 53 Fl. 3, Sofia, 1407, Bulgaria

Human medicinal products

1. MEDICINAL PRODUCTS

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

1.2. without a Marketing Authorisation or registration in the EEA and intended for EEA market*

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

Any restrictions or clarifying remarks (for all users): There is an authorized site without LOC number with address: 1528 Sofia, 5 Dimitar Peshev Blvd., floor 2, korpus B and authorized activities: 1.1, 1.2, 2.1,2.2,2.3,2.4, 3.2

*Art. 5 of Directive 2001/83/EC, Art. 83 of Regulation (EC) 726/2004 and Art. 110 of Regulation 2019/6.

Union Format for a Wholesale Distribution Authorisation	BG/WDA/MP-0536
	Page 1

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