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RTF Template

Chief Pharmaceutical Inspectorate

UNION FORMAT FOR A WHOLESALE DISTRIBUTION AUTHORISATION

Human medicinal products

1. Authorisation Number	:	NOH.5100.28.2018.1110.MP.3
2. Name of Authorisation Holder	:	Alfasigma Polska Sp. z o.o. (ORG-100001529 / LOC-100008131)
3. Address(es) of Site(s)	:	Szyszkowa 20, Warszawa, MAZOWIECKIE, 02-285, Poland

4. Legally registered address of Authorisation Holder	:	Ul. Aleje Jerozolimskie 96, Warsaw, 00-807
5. Scope of authorisation (complete for each site under 4)	:	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 wholesaling authorisation	:	Confidential, Confidential
8. Signature	:
9. Date	:	2018-04-19
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: Hurtownia farmaceutyczna

, Szyszkowa 20, Warszawa, MAZOWIECKIE, 02-285, Poland

Human medicinal products

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

Any restrictions or clarifying remarks (for all users): Hurtownia farmaceutyczna Alfasigma Polska Sp. z o.o. prowadzi obrót produktami leczniczymi, dla których podmiotami odpowiedzialnymi są: Alfasigma Polska Sp. z o.o., Alfasigma S.p.A. lub Chemische Fabrik Kreussler & Co. GmbH.

*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	NOH.5100.28.2018.1110.MP.3
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