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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-0420
2. Name of Authorisation Holder	:	"ВЕГА МЕДИКАЛ" EООД/„VEGA MEDICAL" EOOD
3. Address(es) of Site(s)	:	Bul. Dragan Tsankov 35, Sofia, 1113, Bulgaria

4. Legally registered address of Authorisation Holder	:	район Искър, бул. „Цариградско шосе" № 361, ет. 3/, district Iskar, 361 Tsarigradsko shosse blvd., floor 3, гр.София/Sofia, 1138
5. Scope of authorisation (complete for each site under 4)	:	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 wholesaling authorisation	:	Confidential, Confidential
8. Signature	:
9. Date	:	2023-07-28
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: Vega Medical EOOD

(ORG-100021281 / LOC-100038807)

, Bul. Dragan Tsankov 35, Sofia, 1113, Bulgaria

Human medicinal products

1. MEDICINAL PRODUCTS

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

1.2. without a Marketing Authorisation in the EEA and intended for EEA market

1.3. without a Marketing Authorisation 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

3.1.2. Medicinal products derived from blood

3.1.3. Immunological medicinal products

3.1.4. Radiopharmaceuticals (including radionuclide kits)

3.3. Cold chain products(requiring low temperature handling)

Any restrictions or clarifying remarks (for all users): The site address is: Sofia, district Iskar, j. k. Druzhba 1, 33 Tzvetan Lazarov blvd.

An amendment concerning the name of the authorization holder from Vega Midical EOOD on Intermedica Group EOOD

*Art 5 of Directive 2001/83/EC or Art 83 of Regulation EC/726/2004

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

Union Format for a Wholesale Distribution Authorisation	BG/WDA/MP-0420
	Page 1

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