Tue 3 Nov 2026 22:44:18 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The WDA has been withdrawn, withdrawn date is: 2024-11-13

RTF Template

French National Agency for Medicines and Health Products Safety

UNION FORMAT FOR A WHOLESALE DISTRIBUTION AUTHORISATION

1. Authorisation Number	:	MM 16/373
2. Name of Authorisation Holder	:	LEXPHAR SARL
3. Address(es) of Site(s)	:	ZAC des Playes, 837 bis allée de Paris, LA SEYNE SUR MER, 83500, France

4. Legally registered address of Authorisation Holder	:	ZAC des Playes, 837 bis allée de Paris, LA SEYNE SUR MER, 83500, 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	:	2016-11-09
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: LEXPHAR SARL - LA SEYNE SUR MER

, ZAC des Playes, 837 bis allée de Paris, LA SEYNE SUR MER, 83500, 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): this site is authorized as an ''exploitant''1.2 medicinal products with temporary authorization for use only2.5 the activity, including wholesale and distribution free of charge of operated products, consists in advertising, information, pharmacovigilance, batch follow-up, and if required, withdrawal operationsExploitation may involve all or part of medicinal products with additional requirements

Cet établissement est exploitant 1.2 médicaments sous autorisation temporaire d'utilisation uniquement 2.5 l'activité, incluant la vente en gros et la cession à titre gratuit des produits exploités, comprend les opérations de publicité, information, pharmacovigilance, suivi des lots et, s'il y a lieu, leur retraitL'exploitation peut concerner tout ou partie des médicaments ayant des exigences particulières

*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

Reason for Withdrawing:

R 19/035

Union Format for a Wholesale Distribution Authorisation	MM 16/373
	Page 1

Loading, please wait