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RTF Template

Finnish Medicines Agency

UNION FORMAT FOR A WHOLESALE DISTRIBUTION AUTHORISATION

Human medicinal products

1. Authorisation Number	:	FIMEA/2020/004496
2. Name of Authorisation Holder	:	HSP Pharma Oy (ORG-100019496 / LOC-100058169)
3. Address(es) of Site(s)	:	Puutarhatie 26 A 22, Vantaa, Uusimaa, 01300, Finland

4. Legally registered address of Authorisation Holder	:	Puutarhatie 26 A 22, Vantaa, Uusimaa, 01300
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	:	2020-08-18
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: HSP Pharma Oy

(ORG-100019496 / LOC-100058169)

, Puutarhatie 26 A 22, Vantaa, Uusimaa, 01300, Finland

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*

2. AUTHORISED WHOLESALE DISTRIBUTION OPERATIONS

2.1. Procurement

2.2. Holding

Any restrictions or clarifying remarks (for all users): Procurement is limited to purposes of photographing and calibration of dose dispensing equipment.
Holding is limited to medicinal products that are not used in human or animal.

*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	FIMEA/2020/004496
	Page 1

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