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RTF Template

National Agency for Medicines and Medical Devices

UNION FORMAT FOR A WHOLESALE DISTRIBUTION AUTHORISATION

1. Authorisation Number	:	514D
2. Name of Authorisation Holder	:	S.C. TRANSMEDIC IMPEX S.R.L.
3. Address(es) of Site(s)	:	Str. Ana Aslan nr. 40, Mun. Cluj-Napoca, Jud. Cluj, cod poştal 400258, Romania

4. Legally registered address of Authorisation Holder	:	Str. Ana Aslan nr. 40, Mun. Cluj-Napoca, Jud. Cluj, cod poştal 400258, Romania
5. Scope of authorisation (complete for each site under 4)	:	ANNEX 1
6. Legal basis of authorisation	:
7. Name of responsible officer of the competent authority of the member state granting the wholesaling authorisation	:	Confidential, Confidential
8. Signature	:
9. Date	:	2016-05-27
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: TRANSMEDIC IMPEX S.R.L.

, Str. Ana Aslan nr. 40, Mun. Cluj-Napoca, Jud. Cluj, cod poştal 400258, Romania

1. MEDICINAL PRODUCTS

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

2. AUTHORISED WHOLESALE DISTRIBUTION OPERATIONS

2.1. Procurement

3. MEDICINAL PRODUCTS WITH ADDITIONAL REQUIREMENTS

3.4. Other products: medical devices, biocidal products, dispozitive medicale, biocide

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 SC Fresenius Medical Care 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 SC Fresenius Medical Care 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	514D
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