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RTF Template


Bulgarian Drug Agency

UNION FORMAT FOR A WHOLESALE DISTRIBUTION AUTHORISATION


1. Authorisation Number

:

BG/WDA/MP-0200

2. Name of Authorisation Holder

:

"МЕДЕКС" ООД/ MEDEX ООD

3. Address(es) of Site(s)

:

plot № 048015, Slanchevo, Aksakovo municipality, Varna district, 9144, Bulgaria 

ЕИК / UIC: 131268894, район Нови Искър, община Столична, област София-град, ул. „Чавдар Войвода" № 48, ПИ 5460.19/, Novi Iskar, Sofia-city municipality, Sofia- city district, 48 Chavdar Voyvoda str.,  plot № 5460.19, с. Световрачене /Svetovrachene, 1252, Bulgaria 




4. Legally registered address of Authorisation Holder

:

област София, община Столична, ул. „Чавдар войвода" № 48 /, Sofia district (capital), Stolichna municipality, Chavdar Voyvoda 48 Street, с. Световрачене /Svetovrachene, 1252, 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

:

2020-08-11

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: "МЕДЕКС" ООД /MEDEX ООD

, plot № 048015, Slanchevo, Aksakovo municipality, Varna district, 9144, 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 

   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) 




Name and address of the site: МЕДЕКС ООД / MEDEX OOD

, ЕИК / UIC: 131268894, район Нови Искър, община Столична, област София-град, ул. „Чавдар Войвода" № 48, ПИ 5460.19/, Novi Iskar, Sofia-city municipality, Sofia- city district, 48 Chavdar Voyvoda str.,  plot № 5460.19, с. Световрачене /Svetovrachene, 1252, 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 

   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

BG/WDA/MP-0200


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