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RTF Template

Danish Medicines Agency

UNION FORMAT FOR A WHOLESALE DISTRIBUTION AUTHORISATION

Human medicinal products and Veterinary medicinal products

1. Authorisation Number	:	104415
2. Name of Authorisation Holder	:	2Care4 ApS (ORG-100003780 / LOC-100092047)
3. Address(es) of Site(s)	:	Stenhuggervej 12, Esbjerg V, 6710, Denmark
3.a. Additional details on units inspected of site(s) address(es) (optional) (All authorised sites should be listed if not covered by separate authorisations)	:	Stenhuggervej 12/14, 6710 Esbjerg V

4. Legally registered address of Authorisation Holder	:	Stenhuggervej 12, Esbjerg V, 6710, Denmark
5. Scope of authorisation	:	ANNEX 1
6. Legal basis of authorisation	:	Art. 77(1) of Directive 2001/83/EC Art. 99 of Regulation (EU) 2019/6
7. Name of responsible officer of the competent authority of the member state granting the wholesale distribution authorisation	:	Confidential, Confidential
8. Signature	:
9. Date	:	2025-04-01
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: 2Care4 ApS

(ORG-100003780 / LOC-100092047)

, Stenhuggervej 12, Esbjerg V, 6710, Denmark

Additional details on units inspected of site(s) address(es) (optional) (All authorised sites should be listed if not covered by separate authorisations): Stenhuggervej 12/14, 6710 Esbjerg V

Human medicinal products

Veterinary medicinal products

1. MEDICINAL PRODUCTS

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

2. AUTHORISED WHOLESALE DISTRIBUTION OPERATIONS

2.1. Procurement

2.2. Holding

2.3. Supply

2.4. Export

2.5. Other activities(s): (please specify) Parallel trade and/or parallel distribution (Veterinary Medicnal Products)

2.5. Other activities(s): (please specify) Parallel import and/or parallel distribution (Human Medicinal Products)

3. MEDICINAL PRODUCTS WITH ADDITIONAL REQUIREMENTS

3.2. Products requiring low temperature handling

3.2.1. Temperatures between 2 to 8 °C

3.2.2. Other temperatures: (please specify) 15-25 °C

Union Format for a Wholesale Distribution Authorisation	104415
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