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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-0526
2. Name of Authorisation Holder	:	Lotus Pharma Bulgaria EOOD (ORG-100044382 / LOC-100093345)
3. Address(es) of Site(s)	:	Cherni Vrah No. 102d Floor 4, Triaditsa District, Sofia, 1407, Bulgaria

4. Legally registered address of Authorisation Holder	:	Cherni Vrah No. 102d Floor 4, Triaditsa District, Sofia, 1407, Bulgaria
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	:	2024-10-17
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: Lotus Pharma Bulgaria EOOD

(ORG-100044382 / LOC-100093345)

, Cherni Vrah No. 102d Floor 4, Triaditsa District, Sofia, 1407, Bulgaria

Human medicinal products

1. MEDICINAL PRODUCTS

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

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

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

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): The address of site is:
2400 Radomir, district Pernik, 26 Otets Paisii str.

*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

Union Format for a Wholesale Distribution Authorisation	BG/WDA/MP-0526
	Page 1

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