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RTF Template

French National Agency for Medicines and Health Products Safety

UNION FORMAT FOR A WHOLESALE DISTRIBUTION AUTHORISATION

1. Authorisation Number	:	D 19/233
2. Name of Authorisation Holder	:	SPENGLER SAS
3. Address(es) of Site(s)	:	30, rue Jean de Guiramand, AIX-EN-PROVENCE, 13290, France

4. Legally registered address of Authorisation Holder	:	rue Robert Maréchal,, ZI La Limoise, ISSOUDUN, 36100, France
5. Scope of authorisation (complete for each site under 4)	:	ANNEX 1
6. Legal basis of authorisation	:
7. Name of responsible officer of the competent authority of the member state granting the wholesaling authorisation	:	Confidential, Confidential
8. Signature	:
9. Date	:	2019-12-03
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: SPENGLER SAS

, 30, rue Jean de Guiramand, AIX-EN-PROVENCE, 13290, France

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

2.1. 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: Mr Said Ioughlissen, deputy head of pharmaceutical product inspection and counterfeiting fight department. 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 : M. Said Ioughlissen, chef adjoint 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	D 19/233
	Page 1

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