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RTF Template

State Medicines Control Agency

UNION FORMAT FOR A WHOLESALE DISTRIBUTION AUTHORISATION

Human medicinal products

1. Authorisation Number	:	0968
2. Name of Authorisation Holder	:	Edonum UAB (ORG-100052839 / LOC-100093144)
3. Address(es) of Site(s)	:	Paneriu G. 246-1, Kauno M. Sav., Kovno, 48454, Lithuania

4. Legally registered address of Authorisation Holder	:	Demokratu G. 53, Kauno M. Sav., Kaunas, 48485, Lithuania
5. Scope of authorisation (complete for each site under 4)	:	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 wholesaling authorisation	:	Confidential, Confidential
8. Signature	:
9. Date	:	2024-09-05
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: Edonum UAB

(ORG-100052839 / LOC-100094076)

, Paneriu G. 246-1, Kauno M. Sav., Kovno, 48454, Lithuania

Human medicinal products

1. MEDICINAL PRODUCTS

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

1.2. without a Marketing Authorisation or registration in the EEA and intended for EEA market*

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

2. AUTHORISED WHOLESALE DISTRIBUTION OPERATIONS

2.1. Procurement

2.3. Supply

2.4. Export

2.5. Other activities(s): (please specify) Paralell import and distributionLygiagretus importas ir platinimas

3. MEDICINAL PRODUCTS WITH ADDITIONAL REQUIREMENTS

3.2. Products requiring low temperature handling

3.3. Other products: (please specify here or make a reference to Annex 5) Immunological medicinal products Imunologiniai vaistiniai preparatai

*Art. 5 of Directive 2001/83/EC, Art. 83 of Regulation (EC) 726/2004 and Art. 110 of Regulation 2019/6.

Union Format for a Wholesale Distribution Authorisation	0968
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