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RTF Template

National Authority Of Medicines And Medical Devices

UNION FORMAT FOR A WHOLESALE DISTRIBUTION AUTHORISATION

Human medicinal products

1. Authorisation Number	:	669D
2. Name of Authorisation Holder	:	Sarantis Romania S.A. (ORG-100049938 / LOC-100087189)
3. Address(es) of Site(s)	:	Soseaua Bucuresti Ploiesti Nr. 172-176, Sector 1 Cladirea B Spatiul B2 Etaj 2, Bucharest, 015016, Romania

4. Legally registered address of Authorisation Holder	:	Soseaua Bucuresti Ploiesti Nr. 172-176, Sector 1 Cladirea B Spatiul B2 Etaj 2, Bucharest, 015016
5. Scope of authorisation (complete for each site under 4)	:	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 wholesaling authorisation	:	Confidential, Confidential
8. Signature	:
9. Date	:	10.01.2023
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: Sarantis Romania S.A.

(ORG-100049938 / LOC-100087189)

, Soseaua Bucuresti Ploiesti Nr. 172-176, Sector 1 Cladirea B Spatiul B2 Etaj 2, Bucharest, 015016, Romania

Human medicinal products

1. MEDICINAL PRODUCTS

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

2. AUTHORISED WHOLESALE DISTRIBUTION OPERATIONS

2.1. Procurement

2.3. Supply

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 Alloga Logistics România SRL. are complied with.

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

*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	669D
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