1. Authorisation Number

:

2024_158_1_3_12

2. Name of Authorisation Holder

:

Air Liquide Antilles Guyane

(ORG-100018153 / LOC-100026977)

3. Address(es) of Site(s)

:

Californie, Le Lamentin, 97232, France 

4. Legally registered address of Authorisation Holder

:

Californie, Le Lamentin, 97232, France

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

:

2024-07-22

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

Name and address of the site: Air Liquide Antilles Guyane

(ORG-100018153 / LOC-100026977)

, Californie, Le Lamentin, 97232, France   

Human medicinal products

Any restrictions or clarifying remarks (for all users):  -
Exploitant and wholesale distributor of medicinal gas (Public Health Code Article R.5124-2 3° and 12°)
-
3°: wholesale distribution, advertising, information, pharmacovigilance, batch follow-up and recall of medicinal products other than investigational medicinal products and products cited in art. L. 4211-1 3°; concerns all or part of the medicinal products with additional requirements;
only storage is limited to the categories cited in 3
-
12°: purchase, storage, wholesale distribution, without modification, of packaged medical gas

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 exploitant et distributeur en gros de gaz à usage médical (code de la santé publique art. R.5124-2 3° et 12°)
-
3° : vente en gros ou cession à titre gratuit, publicité, information, pharmacovigilance, suivi et retrait des lots de médicaments autres que les médicaments expérimentaux, de produits cités à l'article L.4211-1 3° ; concerne tout ou partie des médicaments ayant des exigences particulières;
seul le stockage est limité aux catégories citées en 3

12° : achat, stockage, distribution en gros et en l'état de gaz à usage médical conditionnés

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

2024_158_1_3_12

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