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RTF Template

Federal Agency For Medicines And Health Products

UNION FORMAT FOR A WHOLESALE DISTRIBUTION AUTHORISATION

Human medicinal products

1. Authorisation Number	:	934 H
2. Name of Authorisation Holder	:	Exphar (ORG-100015516 / LOC-100024242)
3. Address(es) of Site(s)	:	Avenue Thomas Edison 105, Nivelles, 1402, Belgium

4. Legally registered address of Authorisation Holder	:	Avenue Thomas Edison 105, Nivelles, 1402
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	:	2025-07-01
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: Exphar

(ORG-100015516 / LOC-100024242)

, Avenue Thomas Edison 105, Nivelles, 1402, Belgium

Human medicinal products

1. MEDICINAL PRODUCTS

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

2. AUTHORISED WHOLESALE DISTRIBUTION OPERATIONS

2.1. Procurement

2.2. Holding

2.4. Export

3. MEDICINAL PRODUCTS WITH ADDITIONAL REQUIREMENTS

3.1. Narcotic or psychotropic products**

Any restrictions or clarifying remarks (for all users): 1.3 Warehouse under the authority of the customs.

1.3 Entrepôt placé sous l'autorité des douanes

**Without prejudice to further authorisations as may be required according to national legislation.

Union Format for a Wholesale Distribution Authorisation	934 H
	Page 1

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