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RTF Template

Health Products Regulatory Authority

UNION FORMAT FOR A WHOLESALE DISTRIBUTION AUTHORISATION

1. Authorisation Number	:	W11013/00001
2. Name of Authorisation Holder	:	Biofact Pharma Limited
3. Address(es) of Site(s)	:	Unit D17, M4 Interchange Park, Maynooth Road, Celbridge, Kildare, -, -, Ireland

4. Legally registered address of Authorisation Holder	:	Unit D17, M4 Interchange Park, Celbridge, Kildare, -, -, 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	:	2019-01-10
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: Biofact Pharma Limited

, Unit D17, M4 Interchange Park, Maynooth Road, Celbridge, Kildare, -, -, Ireland

1. MEDICINAL PRODUCTS

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

2. AUTHORISED WHOLESALE DISTRIBUTION OPERATIONS

2.1. Procurement

2.2. Holding

2.3. Supply

3. MEDICINAL PRODUCTS WITH ADDITIONAL REQUIREMENTS

3.1.2. Medicinal products derived from blood

3.1.3. Immunological medicinal products

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 products3.4.2 Medicinal products for general sale3.4.3 Over the counter medicinal products for sale through pharmacies only3.4.12 Exempt medicinal products3.4.13 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	W11013/00001
	Page 1

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