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Information Messages

The WDA has been withdrawn, withdrawn date is: 2024-12-11

RTF Template

French National Agency for Medicines and Health Products Safety

UNION FORMAT FOR A WHOLESALE DISTRIBUTION AUTHORISATION

1. Authorisation Number	:	FD 14/373-MOD1
2. Name of Authorisation Holder	:	JOHNSON & JOHNSON MEDICAL SAS
3. Address(es) of Site(s)	:	1 rue Camille Desmoulins, ISSY LES MOULINEAUX, 92130, France

4. Legally registered address of Authorisation Holder	:	1 rue Camille Desmoulins, ISSY LES MOULINEAUX, 92130, 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	:	2017-12-15
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: JOHNSON & JOHNSON MEDICAL SAS - ISSY LES MOULINEAUX

, 1 rue Camille Desmoulins, ISSY LES MOULINEAUX, 92130, 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''Exploitation

Any restrictions or clarifying remarks (for all users): This site is authorised as an ''exploitant''.
1.2 medicinal products with temporary authorization for use only.
2.5 the activity, including wholesale and distribution free of charge of operated products, consists in advertising, information, pharmacovigilance, batch follow-up, and if required, withdrawal operations.
Exploitation may involve all or part of medicinal products with additional requirements.

Signatory: Mrs Mélanie Cachet, head of pharmaceutical product inspection and counterfeiting fight department
The ANSM does not issue hard copy of this authorisation.
.

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 retrait.
L'exploitation peut concerner tout ou partie des médicaments ayant des exigences particulières.

Signataire : Mme Mélanie Cachet, chef du Pôle inspection des produits pharmaceutiques et lutte contre les fraudes
L'ANSM ne délivre pas de copie papier de cette autorisation.
.

Reason for Withdrawing:

R_2024_048

Union Format for a Wholesale Distribution Authorisation	FD 14/373-MOD1
	Page 1

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