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RTF Template

Chief Pharmaceutical Inspectorate

UNION FORMAT FOR A WHOLESALE DISTRIBUTION AUTHORISATION

Human medicinal products

1. Authorisation Number	:	NZOH.5100.48.2021.MG.4
2. Name of Authorisation Holder	:	Viatris Trade Sp. z o.o. (ORG-100037752 / LOC-100059586)
3. Address(es) of Site(s)	:	Stefana Batorego 4, Pass, mazowieckie, 05-870, Poland

4. Legally registered address of Authorisation Holder	:	Ul. Postepu 21b, Warsaw, 02-676
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	:	2024-04-12
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

, Stefana Batorego 4, Pass, mazowieckie, 05-870, 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

3. MEDICINAL PRODUCTS WITH ADDITIONAL REQUIREMENTS

3.1.3. Immunological medicinal products

3.3. Cold chain products(requiring low temperature handling)

3.4. Other products: 3.4.1 cytotoxic, 3.4.4 medicinal products with very strong effect cytostatyczne produkty lecznicze, produkty lecznicze bardzo silnie działające

Any restrictions or clarifying remarks (for all users): Asortyment ograniczony do następujących produktów leczniczych: (I) produktów leczniczych nabywanych przez Mylan EPD Sp. z o.o. od wytwórców i przedsiębiorców posiadających zezwolenie na prowadzenie hurtowni farmaceutycznej z grupy kapitałowej Viatris, (II) produktów leczniczych, dla których podmiotem odpowiedzialnym lub przedstawicielem podmiotu odpowiedzialnego jest podmiot z grupy kapitałowej Viatris
(III) produktów leczniczych, dla których podmiotem odpowiedzialnym spoza grupy kapitałowej Viatris jest Pharmaselect International Beteiligungs GmbH, Emst-Melchior-Gasse 20 A-1020 Wiedeń, Austria (IV) produktu leczniczego Phlebodia nabywanego przez Mylan EPD Sp. z o.o. od podmiotu odpowiedzialnego spoza grupy kapitałowej Viatris: Laboratoires Innothera 22 Avenue Aristide Briand 94110 Arcueil, Francja.

*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	NZOH.5100.48.2021.MG.4
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