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RTF Template

Bulgarian Drug Agency

UNION FORMAT FOR A WHOLESALE DISTRIBUTION AUTHORISATION

1. Authorisation Number	:	BG/WDA/MP-0250
2. Name of Authorisation Holder	:	" ИВ ФАРМА"ЕООД / "IV PHARMA"EOOD
3. Address(es) of Site(s)	:	8 Iliensko shose str., corpus 1, Sofia, 1220, Bulgaria

4. Legally registered address of Authorisation Holder	:	община Столична, район Красно село, бул. „Македония" № 6, ет. 4, ап. 7 /, Municipality of Sofia, region Krasno selo, 6 Macedonia blvd., fl. 4, app. 7, гр.София/Sofia, 1606, Bulgaria
5. Scope of authorisation (complete for each site under 4)	:	ANNEX 1
6. Legal basis of authorisation	:
7. Name of responsible officer of the competent authority of the member state granting the wholesaling authorisation	:	Confidential, Confidential
8. Signature	:
9. Date	:	2021-02-02
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: " ИВ ФАРМА"ЕООД / "IV PHARMA"EOOD

, 8 Iliensko shose str., corpus 1, Sofia, 1220, Bulgaria

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

3.2. Medicinal gases

3.3. Cold chain products(requiring low temperature handling)

*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-0250
	Page 1

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