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RTF Template

Chief Pharmaceutical Inspectorate

UNION FORMAT FOR A WHOLESALE DISTRIBUTION AUTHORISATION

Human medicinal products

1. Authorisation Number	:	GIF-N-411/609/1-5/MSH/12
2. Name of Authorisation Holder	:	Sanofi Sp. z o.o. (ORG-100001972 / LOC-100090253)
3. Address(es) of Site(s)	:	Ul. Stefana Batorego 1, Pass, Blonie, 05-870, Poland

4. Legally registered address of Authorisation Holder	:	Ul. Marcina Kasprzaka 6, Warsaw, 01-211, Poland
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	:	2024-11-29
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: Sanofi Sp. z o.o.

(ORG-100001972 / LOC-100071474)

, Ul. Stefana Batorego 1, Pass, Blonie, 05-870, Poland

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

2.3. Supply

3. MEDICINAL PRODUCTS WITH ADDITIONAL REQUIREMENTS

3.2. Products requiring low temperature handling

3.2.1. Temperatures between 2 to 8 °C

3.3. Other products: (please specify here or make a reference to Annex 5) 3.1.2 Immunological medicinal products, 3.4.1 Cytotoxic medicinal products, 3.4.4 Medicinal products with very strong effect

Any restrictions or clarifying remarks (for all users): Hurtownia prowadzi obrót produktami leczniczymi, dla których posiadaczami pozwolenia na dopuszczenie do obrotu są podmioty odpowiedzialne: Sanofi-Aventis Deutschland GmbH, Sanofi Belgium, Sanofi Sp. z o. o., Regeneron Ireland Designated Activity Company, Ablynx N.V., CHEPLAPHARM Arzneimittel GmbH, Opella Healthcare Poland Sp. z o.o., Opella Healthcare Commercial Ltd., Sanofi Winthrop Industrie, Sanofi B.V., neuraxpharm Arzneimittel GmbH, Sanofi Pasteur, Sanofi Pasteur Europe, The Simple Pharma Company Limited.
W przypadku dopuszczenia do obrotu produktu leczniczego na podstawie art. 4 Ustawy Prawo Farmaceutyczne, hurtownia prowadzi obrót produktami leczniczymi dla których posiadaczami pozwolenia na dopuszczenie do obrotu są wyżej wymienione podmioty oraz inne niż wyżej wymienione podmioty odpowiedzialne.

*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	GIF-N-411/609/1-5/MSH/12
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