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Information Messages

The WDA has been withdrawn, withdrawn date is: 2025-01-28

RTF Template

National Agency For The Safety Of Medicine And Health Products

UNION FORMAT FOR A WHOLESALE DISTRIBUTION AUTHORISATION

1. Authorisation Number	:	2022_011_3
2. Name of Authorisation Holder	:	DR. FALK PHARMA SAS
3. Address(es) of Site(s)	:	32-36 rue de Bellevue, BOULOGNE BILLANCOURT, 92100, France

4. Legally registered address of Authorisation Holder	:	32-36 rue de Bellevue, BOULOGNE BILLANCOURT, 92100, 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	:	2022-01-14
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: DR. FALK PHARMA SAS

, 32-36 rue de Bellevue, BOULOGNE BILLANCOURT, 92100, 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:

replaced with authorisation 2025_077_3

remplacée par l'autorisation 2025_077_3

Union Format for a Wholesale Distribution Authorisation	2022_011_3
	Page 1

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