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RTF Template

Health Products Regulatory Authority

UNION FORMAT FOR A WHOLESALE DISTRIBUTION AUTHORISATION

Human medicinal products

1. Authorisation Number	:	W11288/00001
2. Name of Authorisation Holder	:	Cyclomedica Europe Limited (ORG-100026176 / LOC-100035451)
3. Address(es) of Site(s)	:	Unit A5 Block A, Calmount Park, Calmount Avenue, Dublin 12, D12 XA06, Ireland

4. Legally registered address of Authorisation Holder	:	Unit A5, Block A, Calmount Avenue, Ballymount, Dublin 12, D12 XA06
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	:	2024-12-10
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: Cyclomedica Europe Limited

(ORG-100026176 / LOC-100035451)

, Unit A5 Block A, Calmount Park, Calmount Avenue, Dublin 12, D12 XA06, Ireland

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

2.2. Holding

2.3. Supply

2.4. Export

3. MEDICINAL PRODUCTS WITH ADDITIONAL REQUIREMENTS

3.3. Other products: (please specify here or make a reference to Annex 5) Please see restrictions or clarifying remarks (for all users).

Any restrictions or clarifying remarks (for all users): 3.3.1 Prescription only medicinal products3.3.4 Unauthorised medicinal productsThe geographic address of the wholesaling site for Cyclomedica Europe Limited is A5 Calmount Business Park, Ballymount, Dublin 12, D12 XA06, Ireland.

Union Format for a Wholesale Distribution Authorisation	W11288/00001
	Page 1

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