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RTF Template

National Agency For The Safety Of Medicine And Health Products

UNION FORMAT FOR A WHOLESALE DISTRIBUTION AUTHORISATION

Human medicinal products

1. Authorisation Number	:	2023_218_1_2_4
2. Name of Authorisation Holder	:	Sogetra (ORG-100025360 / LOC-100057270)
3. Address(es) of Site(s)	:	1 Rue Joseph Flipo, Bp 60031, Coudekerque-Branche, 59210, France

4. Legally registered address of Authorisation Holder	:	Residence Cam Ebene, 10 Quai De La Citadelle, Dunkerque, 59140
5. Scope of authorisation (complete for each site under 4)	:	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 wholesaling authorisation	:	Confidential, Confidential
8. Signature	:
9. Date	:	2023-08-11
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: Sogetra

(ORG-100025360 / LOC-100034574)

, 1 Rue Joseph Flipo, Bp 60031, Coudekerque-Branche, 59210, France

Human medicinal products

1. MEDICINAL PRODUCTS

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

1.2. without a Marketing Authorisation in the EEA and intended for EEA market

2. AUTHORISED WHOLESALE DISTRIBUTION OPERATIONS

2.2. Holding

2.3. Supply

2.4. Export

2.5. Other activities(s): storage and order preparation of non-sterile intermediates/ stockage et préparation de commandes de produits intermédiaires non stériles

Any restrictions or clarifying remarks (for all users): -
Dépositaire (Public Health Code Article R.5124-2 4°)
acting by order and on behalf of:
- one or more "exploitants" of medicinal products, generators, kits and precursors (Article L.4211-1 3°),
- one or more manufacturers or importers of dressing objects or articles presented as complying with the French pharmacopoeia mentioned in Article L.4211-1 2°,
activity: storage with a view to the wholesale distribution without modification of medicines, products, objects or articles not owned by the company.

Signatory: Mrs Florence Descamps-Delesalle, head of pharmaceutical product inspection and counterfeiting fight department
The ANSM does not issue hard copy of this authorisation.
---

Etablissement dépositaire (code de la santé publique art. R.5124-2 4°) se livrant, d'ordre et pour le compte :
-d'un ou plusieurs exploitants de médicaments, de générateurs, trousses ou précurseurs (art. L.4211-1 3°),
-ou d'un ou plusieurs fabricants ou importateurs d'objets de pansement ou articles présentés comme conformes à la Pharmacopée cités à l'art. L.4211-1 2°,
au stockage de ces médicaments ou produits, objets ou articles dont elle n'est pas propriétaire, en vue de leur distribution en gros et en l'état.

Signataire : Mme Florence Descamps-Delesalle, chef du Pôle inspection des produits pharmaceutiques et lutte contre les fraudes
L'ANSM ne délivre pas de copie papier de cette autorisation.

*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	2023_218_1_2_4
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