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Information Messages

The WDA has been withdrawn, withdrawn date is: 2026-03-11

RTF Template

Chief Pharmaceutical Inspectorate

UNION FORMAT FOR A WHOLESALE DISTRIBUTION AUTHORISATION

Human medicinal products

1. Authorisation Number	:	GIF-N-411/199/1-12/TL/15
2. Name of Authorisation Holder	:	Aristo Pharma Sp. z o.o. (ORG-100002937 / LOC-100012973)
3. Address(es) of Site(s)	:	Józefów 9, Kutno, ŁÓDZKIE, 99-300, Poland

4. Legally registered address of Authorisation Holder	:	Ul. Baletowa 30, Warsaw, 02-867
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	:	2023-12-21
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

, Józefów 9, Kutno, ŁÓDZKIE, 99-300, 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

2.4. Export

3. MEDICINAL PRODUCTS WITH ADDITIONAL REQUIREMENTS

3.4. Other products: 3.4.2,

Any restrictions or clarifying remarks (for all users): Obrót hurtowy ograniczony do produktów leczniczych, dla których podmiotem odpowiedzialnym jest Aristo Pharma sp. z o.o., Polfarmex S.A., Aristo Pharma GmbH, Aflofarm Farmacja Polska sp. z o.o., GEMI Przedsiębiorstwo Produkcji Farmaceutycznej Nowakowski Grzegorz, Sun Pharmaceutical Industries Europe B.V., Ranbaxy (Poland) Sp. z o.o. oraz Przedsiębiorstwo Produkcji Farmaceutyczno - Kosmetycznej Profarm Sp. z o.o. W zakresie działalności wskazanym w pkt. 3.4.2 przedsiębiorca prowadzi obrót wyłącznie łatwopalnymi produktami leczniczymi w postaci lakierów do paznokci.

Reason for Withdrawing:

This WDA authorisation is no longer valid. It has been withrawn by decision of competent authority.

To zezwolenie nie jest już aktualne. Zostało wycofane decyzją organu kompetentnego.

Union Format for a Wholesale Distribution Authorisation	GIF-N-411/199/1-12/TL/15
	Page 1

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