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RTF Template

An tÚdarás Rialála Táirgí Sláinte

UNION FORMAT FOR A WHOLESALE DISTRIBUTION AUTHORISATION

1. Authorisation Number	:	W12471/00001
2. Name of Authorisation Holder	:	Earlsfort Regulatory Compliance Ltd T/A The Compliance Group
3. Address(es) of Site(s)	:	84 Venetian Hall, Killester, Dublin 5, -, D05 H519, Ireland

4. Legally registered address of Authorisation Holder	:	26 Upper Pembroke Street, Dublin 2, -, D02 X361, Ireland
5. Scope of authorisation (complete for each site under 4)	:	ANNEX 1
6. Legal basis of authorisation	:
7. Name of responsible officer of the competent authority of the member state granting the wholesaling authorisation	:	Confidential, Confidential
8. Signature	:
9. Date	:	2021-04-09
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: Earlsfort Regulatory Compliance Ltd T/A The Compliance Group

, 84 Venetian Hall, Killester, Dublin 5, -, D05 H519, Ireland

1. MEDICINAL PRODUCTS

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

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

2. AUTHORISED WHOLESALE DISTRIBUTION OPERATIONS

2.1. Procurement

2.3. Supply

2.4. Export

3. MEDICINAL PRODUCTS WITH ADDITIONAL REQUIREMENTS

3.4. Other products: Please see restrictions or clarifying remarks (for all users).

Any restrictions or clarifying remarks (for all users): 3.4.1 Prescription only medicinal products 3.4.2 Medicinal products for general sale 3.4.3 Over the counter medicinal products for sale through pharmacies only 3.4.4 Unauthorised medicinal products 3.4.12 Biological products

*Art 5 of Directive 2001/83/EC or Art 83 of Regulation EC/726/2004

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

Union Format for a Wholesale Distribution Authorisation	W12471/00001
	Page 1

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