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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	:	684D
2. Name of Authorisation Holder	:	Inoxis Medical S.R.L. (ORG-100051015 / LOC-100089289)
3. Address(es) of Site(s)	:	Strada Romanilor 44-46, Hunedoara, 331032, 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)	:	Complet address: Str. Romanilor nr. 44-46, Mun. Hunedoara, Jud. Hunedoara, cod poștal 331032

4. Legally registered address of Authorisation Holder	:	Strada Russo Alecu Nr. 9, Hunedoara, 331119
4.a. Additional details on units inspected of registrant's legal address (optional)	:	Complet address: Str. Alecu Russo nr.9, Mun. Hunedoara, Jud. Hunedoara, cod poștal 331119
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	:	2026-07-07
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: Inoxis Medical S.R.L.

(ORG-100051015 / LOC-100089288)

, Strada Romanilor 44-46, Hunedoara, 331032, Romania

Additional details on units inspected of site(s) address(es) (optional) (All authorised sites should be listed if not covered by separate authorisations): Complet address: Str. Romanilor nr. 44-46, Mun. Hunedoara, Jud. Hunedoara, cod poștal 331032

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

2.4. Export

2.5. Other activities(s): (please specify) CustodyCustodie

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

3.3. Other products: (please specify here or make a reference to Annex 5) medicinal products that have a marketing authorization issued by the competent authorities of a mem medicamente care au autorizaţie de punere pe piaţă eliberată de autorităţile competente ale unui st

Any restrictions or clarifying remarks (for all users): In addition, the transportation is performed by Ahead Translog Solutions SRL which are using transportation hubs in BZ, CJ, DJ, HD, NT, MM and Mun. București counties.

Activitatea de transport se efectuează și de către beneficiarul de contract Ahead Translog Solutions SRL care utilizează noduri de transport în jud. BZ, CJ, DJ, HD, NT, MM și Mun. București.

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

Union Format for a Wholesale Distribution Authorisation	684D
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