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RTF Template

Bulgarian Drug Agency

UNION FORMAT FOR A WHOLESALE DISTRIBUTION AUTHORISATION

Human medicinal products

1. Authorisation Number	:	IV-P-T-EU-245
2. Name of Authorisation Holder	:	" БИОФАРМЕКСПЕРТ"ООД/"BIOFARMEKSPERT" LTD
3. Address(es) of Site(s)	:	3 Stefan Karadja str., village Rogosh, 4000, Bulgaria Suspended

4. Legally registered address of Authorisation Holder	:	ул." Велико Търново"№ 17/17 Veliko Turnovo str., гр. Пловдив/Plovdiv, район Централен/Central region, 4000
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	:	2017-10-20
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: BIOFARMEKSPERT LTD

, 3 Stefan Karadja str., village Rogosh, 4000, Bulgaria Suspended

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): The wholesale Distribution Authorization is suspendet with Order ЗОА-0255/29.04.2025

Разрешението за търговия на едро е суспендирано със ЗОА-0255/29.04.2025

*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	IV-P-T-EU-245
	Page 1

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