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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-0621
2. Name of Authorisation Holder	:	Woerwag Pharma Bulgaria EOOD (ORG-100036437 / LOC-100057610)
3. Address(es) of Site(s)	:	район Сердика, ул. „Първа Българска Армия" 18/, Serdika Region, 18 Parva Bulgarska Armia Str., гр. София / Sofia, 1225, Bulgaria

4. Legally registered address of Authorisation Holder	:	R-N Krasno Selo Distr Floor 12 Block Biznes Tsentar Prima, Ul.Sofiyski Geroy 1, Sofia, 1612
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	:	2026-01-29
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: ВЬОРВАГ ФАРМА БЪЛГАРИЯ ЕOOД/WOERWAG PHARMA BULGARIA EOOD

, район Сердика, ул. „Първа Българска Армия" 18/, Serdika Region, 18 Parva Bulgarska Armia Str., гр. София / Sofia, 1225, 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

3.2. Products requiring low temperature handling

3.2.1. Temperatures between 2 to 8 °C

Any restrictions or clarifying remarks (for all users): The new Legally registered address of authorisation holder is 1612 Sofia, district Krasno selo, 1 Tsar Boris III Blvd, Business Center Grawe, floor 8, but there is no change of the address in ORG number

*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-0621
	Page 1

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