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Information Messages

The WDA has been withdrawn, withdrawn date is: 2026-06-17

RTF Template

National Agency For The Safety Of Medicine And Health Products

UNION FORMAT FOR A WHOLESALE DISTRIBUTION AUTHORISATION

Human medicinal products

1. Authorisation Number	:	2024_077_1_2_4_6_7
2. Name of Authorisation Holder	:	Flavine Pharma France (ORG-100034043 / LOC-100053807)
3. Address(es) of Site(s)	:	3 Voie D Allemagne, Vitrolles, 13127, France

4. Legally registered address of Authorisation Holder	:	3 Voie D Allemagne, Vitrolles, 13127
5. Scope of authorisation	:	ANNEX 1
6. Legal basis of authorisation	:	Art. 77(1) of Directive 2001/83/EC
7. Name of responsible officer of the competent authority of the member state granting the wholesale distribution authorisation	:	Confidential, Confidential
8. Signature	:
9. Date	:	2024-03-06
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: Flavine Pharma France

(ORG-100034043 / LOC-100053807)

, 3 Voie D Allemagne, Vitrolles, 13127, France

Human medicinal products

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

1.3. without a Marketing Authorisation in the EEA and intended for exportation

2. AUTHORISED WHOLESALE DISTRIBUTION OPERATIONS

2.1. Procurement

2.2. Holding

2.3. Supply

2.4. Export

3. MEDICINAL PRODUCTS WITH ADDITIONAL REQUIREMENTS

3.1.1. Narcotic or psychotropic products

3.4. Other products: intermediate products intended for further processing by an authorized manufacturer ---intermédiaires destinés à une transformation ultérieure par un fabricant autorisé

Any restrictions or clarifying remarks (for all users): Dépositaire, wholesale distributor of pharmaceutical products other than medicinal products and of intermediate products, wholesale distributor for export (Public Health Code Article R.5124-2 4° 6° 7°)

4° storage, wholesale distribution of not owned medicinal products, by order and on behalf of exploitants

6° purchase, storage, distribution of intermediates wich undergoe further processing by an authorised manufacturer or products mentioned in Article L.4211-1 2° and 3°

7° purchase, storage with a view to the export without modification of medicinal products other than investigational medicinal products and products mentioned in article L. 4211-1 2°, 3°, 5°

Signatory: Mrs Florence Descamps-Delesalle, head of pharmaceutical product inspection and counterfeiting fight department
The ANSM does not issue hard copy of this authorisation.
__

Établissement dépositaire, distributeur en gros de produits pharmaceutiques autres que les médicaments et de produits intermédiaires, distributeur en gros à l'exportation (code de la santé publique art. R.5124-2 4° 6° 7°)

4° stockage, distribution en gros et en l'état de médicaments dont il n'est pas propriétaire, d'ordre et pour le compte d'exploitants

6° achat, stockage, distribution en gros et en l'état de produits intermédiaires destinés à une transformation ultérieure par un fabricant autorisé ou de produits cités à l'article L.4211-1 2°, 3°

7° achat, stockage en vue de l'exportation en l'état de médicaments autres que des médicaments expérimentaux et de produits cités à l'article L.4211-1 2°, 3°, 5°

Signataire: Mme Florence Descamps-Delesalle, 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:

replaced by WDA #2026_041_1_2_4_6_7

remplacée par la WDA 2026_041_1_2_4_6_7

Union Format for a Wholesale Distribution Authorisation	2024_077_1_2_4_6_7
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