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RTF Template

Bulgarian Drug Agency

UNION FORMAT FOR A WHOLESALE DISTRIBUTION AUTHORISATION

1. Authorisation Number	:	BG/WDA/MP-0033
2. Name of Authorisation Holder	:	,,ЛИНДЕ ГАЗ БЪЛГАРИЯ" ЕООД / ,,LINDE GAS BULGARIA" EOOD
3. Address(es) of Site(s)	:	Industrial zone res.area ( on the territory of Agrobiobiohim), Стара Загора/Stara Zagora 6000, 6000, Bulgaria

4. Legally registered address of Authorisation Holder	:	кв.Инд. зона (на тер. на Агробиохим)/Ind. zone,Agrobiohim teritory, Стара Загора/ Stara Zagora, 6000, 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	:	2018-06-25
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: ,,ЛИНДЕ ГАЗ БЪЛГАРИЯ" ЕООД / ,,LINDE GAS BULGARIA" EOOD

, Industrial zone res.area ( on the territory of Agrobiobiohim), Стара Загора/Stara Zagora 6000, 6000, 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

2. AUTHORISED WHOLESALE DISTRIBUTION OPERATIONS

2.1. Procurement

2.2. Holding

2.3. Supply

3. MEDICINAL PRODUCTS WITH ADDITIONAL REQUIREMENTS

3.2. Medicinal gases

*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-0033
	Page 1

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