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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-0684
2. Name of Authorisation Holder	:	"ФОРТЕКС НУТРАСЮТИКАЛС" ООД/Fortex Nutraceuticals OOD
3. Address(es) of Site(s)	:	Ulitsa Prohladen Kat 10, Suhodol, 1362, Bulgaria

4. Legally registered address of Authorisation Holder	:	район Овча купел, кв. Суходол, ул. "Прохладен кът" № 10/, region Ovcha kupel, Suhodol district, 10 Prohladen kat street, ЕИК / UIC: 175224764, гр. София/Sofia, 1362
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	:	2026-10-22
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: Fortex Nutraceuticals OOD

(ORG-100009002 / LOC-100028670)

, Ulitsa Prohladen Kat 10, Suhodol, 1362, Bulgaria

Human medicinal products

1. MEDICINAL PRODUCTS

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

2. AUTHORISED WHOLESALE DISTRIBUTION OPERATIONS

2.1. Procurement

2.2. Holding

2.3. Supply

2.4. Export

Union Format for a Wholesale Distribution Authorisation	BG/WDA/MP-0684
	Page 1

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