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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	:	2082 H
2. Name of Authorisation Holder	:	Energia Pharma Services (ORG-100041531 / LOC-100068390)
2.a. Alternative name of authorisation holder (optional)	:	Energia Pharma Services N.V.
3. Address(es) of Site(s)	:	Slachthuisstraat 30 Bus 7, Turnhout, 2300, Belgium

4. Legally registered address of Authorisation Holder	:	Slachthuisstraat 30 Bus 7, Turnhout, Antwerp, 2300
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	:	2025-03-30
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: Energia Pharma Services

(ORG-100041531 / LOC-100068390)

, Slachthuisstraat 30 Bus 7, Turnhout, 2300, Belgium

Human medicinal products

1. MEDICINAL PRODUCTS

1.1. with a Marketing Authorisation or registration in EEA country(s)

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

2. AUTHORISED WHOLESALE DISTRIBUTION OPERATIONS

2.1. Procurement

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.
3.1.1.: According to the Belgian law of 24/02/1921 concerning the traffic in poisons, soporific and narcotic drugs, disinfectants and antiseptics, the company is not authorized to physically hold the products.

1.3.: Opslagplaats onder de bevoegdheid van de douanes.
3.1.1.: Volgens de Belgische wet van 24/02/1921 betreffende het verhandelen van giftstoffen, slaapmiddelen en verdovende middelen, ontsmettingsstoffen en antiseptica, is de firma niet vergund voor het fysisch houden van deze producten.

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

Union Format for a Wholesale Distribution Authorisation	2082 H
	Page 1

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