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RTF Template


Bulgarian Drug Agency

UNION FORMAT FOR A WHOLESALE DISTRIBUTION AUTHORISATION


1. Authorisation Number

:

IV-Р-Т-EU-S-150-2

2. Name of Authorisation Holder

:

"ЦИТО КЪМПАНИ" ООД / CITO COMPANY OOD

3. Address(es) of Site(s)

:

район Надежда, ул. "Бяла бука" № 1/area Nadezhda, 1 Byala Buka str., гр. София/ Sofia, 1220, Bulgaria 




4. Legally registered address of Authorisation Holder

:

район Надежда, ул."Бяла бука" №1/, area Nadezhda, 1 Byala Buka str., гр.София / Sofia, 1220, 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

:

2015-07-14

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: "ЦИТО КЪМПАНИ" ООД / CITO COMPANY OOD

, район Надежда, ул. "Бяла бука" № 1/area Nadezhda, 1 Byala Buka str., гр. София/ 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

   3.3. 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-Р-Т-EU-S-150-2


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