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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	:	673D
2. Name of Authorisation Holder	:	Swixx Biopharma S.R.L. (ORG-100039433 / LOC-100095786)
3. Address(es) of Site(s)	:	Soseaua Bucuresti Ploiesti Nr 1a Cladire A Etaj 1 Sector 1, Bucharest, 013681, Romania

4. Legally registered address of Authorisation Holder	:	Soseaua Bucuresti Ploiesti Nr 1a Cladire A Etaj 1 Sector 1, Bucharest, 013681
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	:	2024-12-03
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: Swixx Biopharma S.R.L.

(ORG-100039433 / LOC-100095786)

, Soseaua Bucuresti Ploiesti Nr 1a Cladire A Etaj 1 Sector 1, Bucharest, 013681, 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

2.3. Supply

3. MEDICINAL PRODUCTS WITH ADDITIONAL REQUIREMENTS

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) free medical samples, medicines for special needs mostre medicale gratuite, medicamente pentru nevoi speciale

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 Alloga Logistics 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 Alloga Logistics România SRL.

Union Format for a Wholesale Distribution Authorisation	673D
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