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RTF Template

Chief Pharmaceutical Inspectorate

UNION FORMAT FOR A WHOLESALE DISTRIBUTION AUTHORISATION

1. Authorisation Number	:	NOH.5100.97.2018.1142.TK.7
2. Name of Authorisation Holder	:	HENRY KRUSE SP. Z O.O.
3. Address(es) of Site(s)	:	Okólna 40, Marki, mazowieckie, 05-270, Poland

4. Legally registered address of Authorisation Holder	:	Kolejowa 3, Bielany Wrocławskie, dolnośląskie, 55-040, Poland
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	:	2019-07-04
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

, Okólna 40, Marki, mazowieckie, 05-270, Poland

1. MEDICINAL PRODUCTS

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

2. AUTHORISED WHOLESALE DISTRIBUTION OPERATIONS

2.1. Procurement

2.2. Holding

3. MEDICINAL PRODUCTS WITH ADDITIONAL REQUIREMENTS

3.4. Other products: 3.4.2

Any restrictions or clarifying remarks (for all users): W Zastrzeżeniach w Aneksie nr 1 zawarty jest wykaz produktów leczniczych w formie tabeli, która zawiera listę 48 pozycji produktów leczniczych.
Szczegółowa lista 48 pozycji jest możliwa do zweryfikowania u przedsiębiorcy posiadającego Zezwolenie w formie papierowej oraz w tutejszym urzędzie.

*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.5100.97.2018.1142.TK.7
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