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RTF Template

Chief Pharmaceutical Inspectorate

UNION FORMAT FOR A WHOLESALE DISTRIBUTION AUTHORISATION

Human medicinal products

1. Authorisation Number	:	NOH.5100.30.2018.1112.MP.1
2. Name of Authorisation Holder	:	Pierre Fabre Dermo-Cosmetique Polska Sp. z o.o. (ORG-100038477 / LOC-100060478)
3. Address(es) of Site(s)	:	Ul. Stefana Batorego 1, Pass, Blonie, 05-870, Poland

4. Legally registered address of Authorisation Holder	:	Ul. Belwederska 20/22, Warsaw, 00-762, Poland
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	:	2018-04-04
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: Pierre Fabre Dermo-Cosmetique Polska Sp. z o.o.

(ORG-100038477 / LOC-100093174)

, Ul. Stefana Batorego 1, Pass, Blonie, 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

3. MEDICINAL PRODUCTS WITH ADDITIONAL REQUIREMENTS

3.4. Other products: 3.4.2, 3.4.6

Any restrictions or clarifying remarks (for all users): Obrót produktami leczniczymi i wyrobami medycznymi, dla których podmiotem odpowiedzialnym lub wytwórcą jest właściwy podmiot z Grupy Pierre Fabre. W zakresie 3.4.2 produkty lecznicze niebezpieczne, w tym łatwopalne, lotne i żrące (Dangerous medicinal products) asortyment ograniczony wyłącznie do produktów leczniczych: Alopexy (Minoxidilum) oraz Clarelux (Clobetasoli propionas), które nie wymagają szczególnych warunków przechowywania.

*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.5100.30.2018.1112.MP.1
	Page 1

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