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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	:	640D
2. Name of Authorisation Holder	:	Salofarm Logistic S.R.L. (ORG-100036334 / LOC-100057449)
3. Address(es) of Site(s)	:	Strada Tolstoi Alexei Nr 67, Bacau, 600293, Romania

4. Legally registered address of Authorisation Holder	:	Strada Tolstoi Alexei Nr 67, Bacau, 600293
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	:	2025-02-10
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: Salofarm Logistic S.R.L.

(ORG-100036334 / LOC-100057449)

, Strada Tolstoi Alexei Nr 67, Bacau, 600293, 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

2.2. 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

Any restrictions or clarifying remarks (for all users): In addition, the transportation is performed by Pharma ExpertSpedition SRL which are using transit storage transportation hubs in BC, IS, SV counties.

Activitatea de transport se efectuează şi de către beneficiarul de contract Pharma ExpertSpedition SRL care utilizează noduri de transport în judeţele BC, IS, SV.

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

Union Format for a Wholesale Distribution Authorisation	640D
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