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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-0617

2. Name of Authorisation Holder

:

Uni Farmas AD

(ORG-100052345 / LOC-100100458)

3. Address(es) of Site(s)

:

Angel Kotselyanov 1b Street, Breznik, Oblast Pernik, 2360, Bulgaria 

Okolovrasten Pat Str. 27, Business center Earth and People, Sofia, 1404, Bulgaria 




4. Legally registered address of Authorisation Holder

:

Okolovrasten Pat Str. 27, Business center Earth and People, Sofia, 1404

5. Scope of authorisation

:

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 wholesale distribution authorisation

:

Confidential, Confidential

8. Signature

:


9. Date

:

2026-01-27

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: Uni Farmas AD

(ORG-100052345 / LOC-100092182)

, Angel Kotselyanov 1b Street, Breznik, Oblast Pernik, 2360, Bulgaria   



Human medicinal products


1. MEDICINAL PRODUCTS

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

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

   1.3. without a Marketing Authorisation or registration 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. Narcotic or psychotropic products** 

   3.2. Products requiring low temperature handling 

     3.2.1. Temperatures between 2 to 8 °C 

   3.3. Other products: (please specify here or make a reference to Annex 5) Medicinal products derived from blood,immunological medicinal products and Cytotoxic products




Name and address of the site: Uni Farmas AD

(ORG-100052345 / LOC-100100458)

, Okolovrasten Pat Str. 27, Business center Earth and People, Sofia, 1404, Bulgaria   



Human medicinal products


1. MEDICINAL PRODUCTS

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

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

   1.3. without a Marketing Authorisation or registration 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

   3.2. Products requiring low temperature handling 

     3.2.1. Temperatures between 2 to 8 °C 

   3.3. Other products: (please specify here or make a reference to Annex 5) Medicinal products derived from blood,immunological medicinal products and Cytotoxic products





*Art. 5 of Directive 2001/83/EC, Art. 83 of Regulation (EC) 726/2004 and Art. 110 of Regulation 2019/6.

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













Union Format for a Wholesale Distribution Authorisation

BG/WDA/MP-0617


Page 1





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