1. Authorisation Number

:

470D

2. Name of Authorisation Holder

:

Oxygen Pharma Services S.R.L.

(ORG-100038157 / LOC-100068487)

3. Address(es) of Site(s)

:

Strada Caderea Bastiliei Nr 33, Bucharest, 010613, Romania 

3.a. Additional details on units inspected of site(s) address(es) (optional) (All authorised sites should be listed if not covered by separate authorisations)

:

Str. Căderea Bastiliei nr. 33, Mansardă, camera 7, biroul nr.2,  Mun. Bucureşti, sectorul 1, cod poştal 010613 

4. Legally registered address of Authorisation Holder

:

Strada Alexander Von Humboldt 3, Ap. 36, Bucharest, 031472

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

:

Str. Alexander von Humboldt nr.3, camera nr.1, bloc V28, scara 2, etaj 4, Ap.36, Mun. Bucureşti, sectorul 3, cod poştal 031472

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

:

2022-01-05

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

Name and address of the site: Oxygen Pharma Services S.R.L.

(ORG-100038157 / LOC-100079535)

, Strada Caderea Bastiliei Nr 33, Bucharest, 010613, Romania   

Additional details on units inspected of site(s) address(es) (optional) (All authorised sites should be listed if not covered by separate authorisations): Str. Căderea Bastiliei nr. 33, Mansardă, camera 7, biroul nr.2,  Mun. Bucureşti, sectorul 1, cod poştal 010613

Human medicinal products

Any restrictions or clarifying remarks (for all users):  The current WDA is valid only if the terms of the storage and logistical services agreement (storage, handling, transport) signed with SC BIO EEL  SRL(working point Ploiesti ) are complied with.

Prezenta Autorizaţie de distribuţie angro este validă numai respectându-se prevederile contractului de custodie şi prestări servicii logistice încheiat cu (punct de lucru Ploieşti).

*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

470D

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