Fri 6 Nov 2026 02:08:03 BST

Search Company

OMS Organisation Identifier:

OMS Location Identifier:

NCA Reference Key:

Address:

Country:

Active Substance

New Active Substance

Search Site

Create Site

Update Site

Current data stored in EudraGMDP database

Current data stored in OMS

DUNS Number:

NCA Reference Key:

Site Name:

OMS Organisation Identifier:

OMS Location Identifier:

Address Line 1:

Address Line 2:

Address Line 3:

Address Line 4:

City:

County:

Postcode:

Country:

Additional Details on Units Inspected

Site under Compliance Management:

Compliance Management comments:

Characters remaining:4000/4000

Overwrite with current OMS data.:

New Active Substance Importation

Active Substance*

Active Substance (English):
Active Substance (NL):
NCA Reference Key:

3rd Country Manufacturer

3rd Country Manufacturer	OMS Location Identifier	OMS Organisation Identifier	Legal Address	NCA Reference Key	Confidential	Edit	Delete
No records found.

3rd Country Distributor

3rd Country Distributor	OMS Location Identifier	OMS Organisation Identifier	Legal Address	NCA Reference Key	Confidential	Edit	Delete
No records found.

Information Messages

The WDA has been withdrawn, withdrawn date is: 2024-12-04

RTF Template

French National Agency for Medicines and Health Products Safety

UNION FORMAT FOR A WHOLESALE DISTRIBUTION AUTHORISATION

1. Authorisation Number	:	FD 20/025
2. Name of Authorisation Holder	:	BLUEBIRD BIO (FR) SAS
3. Address(es) of Site(s)	:	75 boulevard Haussmann, PARIS, 75008, France

4. Legally registered address of Authorisation Holder	:	75 boulevard Haussmann, PARIS, 75008, France
5. Scope of authorisation	:	ANNEX 1
6. Legal basis of authorisation	:
7. Name of responsible officer of the competent authority of the member state granting the wholesale distribution authorisation	:	Confidential, Confidential
8. Signature	:
9. Date	:	2020-02-18
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: BLUEBIRD BIO (FR) SAS

, 75 boulevard Haussmann, PARIS, 75008, 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

2.3. Supply

2.4. Export

2.5. Other activities(s): Exploitation

Any restrictions or clarifying remarks (for all users): -
Exploitant (Public Health Code Article R.5124-2 3°)
Exploitation of medicinal products other than investigational medicinal products: wholesale and distribution free of charge, advertising, information, pharmacovigilance, batch follow-up and recall; may concern all or part of the medicinal products with additional requirements.

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

Etablissement exploitant (code de la santé publique art. R.5124-2 3°)
Exploitation de médicaments autres que les médicaments expérimentaux : vente en gros ou cession à titre gratuit, publicité, information, pharmacovigilance, suivi et retrait des lots ; peut concerner tout ou partie des médicaments ayant des exigences particulières.

Signataire: Mme Mélanie Cachet, directrice adjointe - Direction de l'inspection
L'ANSM ne délivre pas de copie papier de cette autorisation.

Reason for Withdrawing:

site closed (R_2021_056)

établissement fermé (R_2021_056)

Union Format for a Wholesale Distribution Authorisation	FD 20/025
	Page 1

Loading, please wait