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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-0628
2. Name of Authorisation Holder	:	World Medicine Europe EOOD (ORG-100009835 / LOC-100096792)
3. Address(es) of Site(s)	:	район Люлин, ул. „Андрей Германов" № 11/region Lyulin, 11 Andrey Germanov str., гр. София / Sofia, 1336, Bulgaria

4. Legally registered address of Authorisation Holder	:	Ulitsa Boris Rumenov 16, Sofia, Oblast Sofia Grad, 1407
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	:	2026-03-05
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: ВОРЛД МЕДИСИНЕ ЕВРОПА ЕООД/WORLD MEDICINE EUROPE LTD

, район Люлин, ул. „Андрей Германов" № 11/region Lyulin, 11 Andrey Germanov str., гр. София / Sofia, 1336, 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

2.2. 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 second authorized site without LOC number with address: 1532 Sofia, municipality Stolichna, 454A Okolovrasten pat Str. and authorized activities: 1.1, 1.2, 1.3, 2.2, 2.3, 2.4, 3.2.1

*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-0628
	Page 1

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