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RTF Template

Chief Pharmaceutical Inspectorate

UNION FORMAT FOR A WHOLESALE DISTRIBUTION AUTHORISATION

Human medicinal products

1. Authorisation Number	:	NOH.5100.61.2018.1121.MP.3
2. Name of Authorisation Holder	:	Galderma Polska Sp. z o.o. (ORG-100002608 / LOC-100032421)
3. Address(es) of Site(s)	:	Ul. Poludniowa 2, Oltarzew, Ozarow Mazowiecki, 05-850, Poland

4. Legally registered address of Authorisation Holder	:	Ul. Pulawska 145, Warsaw, 02-715
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	:	2025-08-20
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: Galderma Polska Sp. z o.o.

(ORG-100002608 / LOC-100069432)

, Ul. Poludniowa 2, Oltarzew, Ozarow Mazowiecki, 05-850, Poland

Human medicinal products

1. MEDICINAL PRODUCTS

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

2. AUTHORISED WHOLESALE DISTRIBUTION OPERATIONS

2.1. Procurement

2.2. Holding

2.3. Supply

3. MEDICINAL PRODUCTS WITH ADDITIONAL REQUIREMENTS

3.2. Products requiring low temperature handling

3.2.2. Other temperatures: (please specify) Poniżej 8 °C

3.3. Other products: (please specify here or make a reference to Annex 5) 3.4.4. Medicinal products with very strong effect

Any restrictions or clarifying remarks (for all users): Przedmiotem obrotu są produkty lecznicze, dla których podmiotem odpowiedzialnym jest Galderma Polska Sp. z o.o., lub Galderma International Francja oraz produkty lecznicze Azzalure, Alluzience i Relfydess, dla których podmiotem odpowiedzialnym jest Ipsen Pharma Francja.

Union Format for a Wholesale Distribution Authorisation	NOH.5100.61.2018.1121.MP.3
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