1. Authorisation Number

:

FD 20/175

2. Name of Authorisation Holder

:

ORPHELIA Pharma

3. Address(es) of Site(s)

:

85 Boulevard Saint Michel, PARIS, 75 005, France 

4. Legally registered address of Authorisation Holder

:

85 Boulevard Saint Michel, PARIS, 75 005, 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

:

2020-11-18

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

Name and address of the site: ORPHELIA PHARMA

, 85 Boulevard Saint Michel, PARIS, 75 005, France   

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: Mr Said Ioughlissen, deputy head of the pharmaceutical product inspection and counterfeiting fight department. 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 : M. Said Ioughlissen, chef adjoint du Pôle inspection des produits pharmaceutiques et lutte contre les fraudes. L'ANSM ne délivre pas de copie papier de cette autorisation.

*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:

Abrogated by decision 2024_187_3

Abrogée par la décision 2024_187_3

Union Format for a Wholesale Distribution Authorisation

FD 20/175

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