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RTF Template


National Authority Of Medicines And Medical Devices Of Romania

UNION FORMAT FOR A WHOLESALE DISTRIBUTION AUTHORISATION

Human medicinal products


1. Authorisation Number

:

687D

2. Name of Authorisation Holder

:

Nexxus Pharma Distribution S.R.L.

(ORG-100050787 / LOC-100095065)

3. Address(es) of Site(s)

:

Strada Bucuresti Targoviste Nr 12a Corp D Et 1 Birou 3, Mogosoaia, 077135, Romania 




4. Legally registered address of Authorisation Holder

:

Calea Mosilor Nr 158, Bucharest, 020883, Romania

4.a. Additional details on units inspected of registrant's legal address (optional)

:

Completed address: Calea Moșilor nr.158, Camera 4, Modul 334, Etaj4, Mun. București, sector 2, cod poştal 020883

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

:

2025-01-17

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: Nexxus Pharma Distribution S.R.L.

(ORG-100050787 / LOC-100089744)

, Strada Bucuresti Targoviste Nr 12a Corp D Et 1 Birou 3, Mogosoaia, 077135, Romania   



Human medicinal products


1. MEDICINAL PRODUCTS

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

2. AUTHORISED WHOLESALE DISTRIBUTION OPERATIONS

   2.1. Procurement 

   2.3. Supply 


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 




Any restrictions or clarifying remarks (for all users):  The current WDA is valid only if the terms of the storage and logistical services agreement signed with VERSUS PHARMA LOGISTICS SRL are complied with.In addition, the transportation is performed by Wellivery Business SRL and Pharma Expert Spedition SRL which uses transport nodes in the following counties: DJ,TM,AB,CJ,BC,IS,SV,BR,BV,CT și Mun. București

Prezenta Autorizaţie de distribuţie angro este validă numai respectându-se prevederile contractului de custodie şi prestări servicii logistice încheiat cu VERSUS PHARMA LOGISTICS SRL.Activitatea de transport se efectuează de către beneficiarul de contract Wellivery Business SRL și Pharma Expert Spedition SRL care utilizează noduri de transport în jud. DJ,TM,AB,CJ,BC,IS,SV,BR,BV,CT și Mun. București



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













Union Format for a Wholesale Distribution Authorisation

687D


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