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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

:

2022_042_1_12

2. Name of Authorisation Holder

:

Air Liquide Antilles Guyane

(ORG-100018153 / LOC-100026977)

3. Address(es) of Site(s)

:

Lauricisque ZI Bergevin, BP 411, Pointe A Pitre, 97163, France 




4. Legally registered address of Authorisation Holder

:

Californie, Le Lamentin, 97232

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

:

2022-07-06

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: Air Liquide Antilles Guyane

(ORG-100018153 / LOC-100062258)

, Lauricisque ZI Bergevin, BP 411, Pointe A Pitre, 97163, France   



Human medicinal products


1. MEDICINAL PRODUCTS

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


2. AUTHORISED WHOLESALE DISTRIBUTION OPERATIONS

   2.1. Procurement 

   2.2. Holding 

   2.3. Supply 

   2.4. Export 


3. MEDICINAL PRODUCTS WITH ADDITIONAL REQUIREMENTS

   3.2. Medicinal gases 




Any restrictions or clarifying remarks (for all users):  -
Wholesale distributor of medicinal gas (Public Health Code Article R.5124-2 12°)
Activity: purchasing and storage operations with a view to the wholesale distribution without modification of packaged medical gas

Signatory:Mrs Mélanie Cachet, deputy director - Inspection division --- The ANSM does not issue hard copy of this authorisation.
---

Etablissement distributeur en gros de gaz à usage médical (code de la santé publique art. R.5124-2 12°) se livrant à l'achat et au stockage de gaz à usage médical conditionnés, en vue de leur distribution en gros et en l'état

Signataire: Mme Mélanie Cachet, directrice adjointe - Direction de l'inspection ---  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

2022_042_1_12


Page 1





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