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Information Messages

The WDA has been withdrawn, withdrawn date is: 2025-10-14

RTF Template

National Authority Of Medicines And Medical Devices Of Romania

UNION FORMAT FOR A WHOLESALE DISTRIBUTION AUTHORISATION

Human medicinal products

1. Authorisation Number	:	629D
2. Name of Authorisation Holder	:	DEPOLIFE CONCEPT SRL
3. Address(es) of Site(s)	:	Soseaua Chitilei Nr. 413, 1st District, Bucharest, 12391, 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)	:	Complete address: Șoseaua Chitilei nr. 413, Sector 1, București, cod poştal 012391

4. Legally registered address of Authorisation Holder	:	Str. Decebal nr.172,Camera nr.5, Comuna Cernica, Județ Ilfov, Cod poştal 077035
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	:	2024-06-03
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: Depolife Concept S.R.L.

(ORG-100037881 / LOC-100097681)

, Soseaua Chitilei Nr. 413, 1st District, Bucharest, 12391, Romania

Additional details on units inspected of site(s) address(es) (optional) (All authorised sites should be listed if not covered by separate authorisations): Complete address: Șoseaua Chitilei nr. 413, Sector 1, București, cod poştal 012391

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

2.2. Holding

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

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

Reason for Withdrawing:

withdrawal

Union Format for a Wholesale Distribution Authorisation	629D
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