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RTF Template

Bulgarian Drug Agency

UNION FORMAT FOR A WHOLESALE DISTRIBUTION AUTHORISATION

1. Authorisation Number	:	IV-P-T-EU-S-010-1
2. Name of Authorisation Holder	:	ГЕНЕРИКА ООД /GENERICA OOD
3. Address(es) of Site(s)	:	кв."Индустриален" Ж13 / Industrial area Zh 13, гр.Стара Загора / Stara Zagora, 6000, Bulgaria

4. Legally registered address of Authorisation Holder	:	район "Младост"; ж.к."Младост"; бул.'Република"№15/, region "Mladost'; complex "Mladost"; 15"Republika"blv;, гр.Варна/Varna, 9020, 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	:	2015-08-10
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: ГЕНЕРИКА ООД /GENERICA OOD

, кв."Индустриален" Ж13 / Industrial area Zh 13, гр.Стара Загора / Stara Zagora, 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

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

3.1.1. Narcotic or psychotropic products

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	IV-P-T-EU-S-010-1
	Page 1

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