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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-0551
2. Name of Authorisation Holder	:	Sidaya Pharma Bulgaria Ltd. (ORG-100046146 / LOC-100076128)
3. Address(es) of Site(s)	:	Bl 16а Apartment 1 1 R Sofia Park, Sofia, 1766, Bulgaria

4. Legally registered address of Authorisation Holder	:	Bl 16а Apartment 1 1 R Sofia Park, Sofia, 1766, 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	:	2025-03-21
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: Sidaya Pharma Bulgaria Ltd.

(ORG-100046146 / LOC-100076128)

, Bl 16а Apartment 1 1 R Sofia Park, Sofia, 1766, 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*

1.3. without a Marketing Authorisation or registration in the EEA and intended for exportation

2. AUTHORISED WHOLESALE DISTRIBUTION OPERATIONS

2.1. Procurement

2.2. Holding

2.3. Supply

2.4. Export

Any restrictions or clarifying remarks (for all users): There is an authorized site without LOC number with address:
1298 Sofia, Nadezda district, Trebich quarter-Stopanski dvor, 19 Dolo str.
An amendment concerning the address of the authorisation holder - 1618 Sofia, district Vitosha, 118 Bulgaria Blvd., Abacus Business Center, 5 - th floor

*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-0551
	Page 1

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