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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-0675
2. Name of Authorisation Holder	:	КОМТУР ФАРМАСЮТИКЪЛС БЪЛГАРИЯ ЕООД/KOMTUR PHARMACEUTICALS BULGARIA LTD
3. Address(es) of Site(s)	:	Ulitsa Iztochna Tangenta 161, Sofiya, Oblast Sofiya Grad, 1592, Bulgaria

4. Legally registered address of Authorisation Holder	:	ЕИК / UIC: 205900411, район Аспарухово, ул. „Капитан I-ви ранг Георги Купов" № 52, ап. 7 /, Asparuhovo region, 52 Caipitan I rank, Georgi Kupov str., apt. 7, гр. Варна/Varna, 9000
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	:	2026-09-18
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: Komtur Pharmaceuticals Bulgria Ltd.

(ORG-100036328 / LOC-100100583)

, Ulitsa Iztochna Tangenta 161, Sofiya, Oblast Sofiya Grad, 1592, 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

3. MEDICINAL PRODUCTS WITH ADDITIONAL REQUIREMENTS

3.1. Narcotic or psychotropic products**

3.2. Products requiring low temperature handling

3.2.1. Temperatures between 2 to 8 °C

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

**Without prejudice to further authorisations as may be required according to national legislation.

Union Format for a Wholesale Distribution Authorisation	BG/WDA/MP-0675
	Page 1

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