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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

:

388D

2. Name of Authorisation Holder

:

Maxi-Farma Warehouse S.R.L.

(ORG-100035420 / LOC-100086967)

3. Address(es) of Site(s)

:

Soseaua Ploiesti-Targoviste Km 8, East Zone Building II Building C2 Room 13 Floor 1, Ploiesti, Prahova, 100302, Romania 




4. Legally registered address of Authorisation Holder

:

Soseaua Ploiesti-Targoviste Km 8, East Zone Building II Building C2 Room 13 Floor 1, Ploiesti, Prahova, 100302

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

:

2026-07-10

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: Maxi-Farma Warehouse S.R.L.

(ORG-100035420 / LOC-100086967)

, Soseaua Ploiesti-Targoviste Km 8, East Zone Building II Building C2 Room 13 Floor 1, Ploiesti, Prahova, 100302, 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 

   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 




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 MAXIFARMA HEALTHCARE SRL are complied with.

Prezenta Autorizaţie de distribuţie angro este validă numai respectându-se prevederile contractului de custodie şi prestări servicii logistice încheiat cu MAXIFARMA HEALTHCARE SRL.















Union Format for a Wholesale Distribution Authorisation

388D


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