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RTF Template

The Chief Pharmaceutical Inspectorate

UNION FORMAT FOR A WHOLESALE DISTRIBUTION AUTHORISATION

1. Authorisation Number	:	GIF-N-411/1029/1-3/TL/16
2. Name of Authorisation Holder	:	Janssen-Cilag Polska sp. z o.o.
3. Address(es) of Site(s)	:	Stefana Batorego 1, Pass, MAZOWIECKIE, 05-870, Poland

4. Legally registered address of Authorisation Holder	:	Iłżecka 24, Warszawa, MAZOWIECKIE, 02-135, Poland
5. Scope of authorisation (complete for each site under 4)	:	ANNEX 1
6. Legal basis of authorisation	:
7. Name of responsible officer of the competent authority of the member state granting the wholesaling authorisation	:	Confidential, Confidential
8. Signature	:
9. Date	:	2016-11-07
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 1, Pass, MAZOWIECKIE, 05-870, Poland

1. MEDICINAL PRODUCTS

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

1.2. without a Marketing Authorisation in the EEA and intended for EEA market

2. AUTHORISED WHOLESALE DISTRIBUTION OPERATIONS

2.1. Procurement

2.2. Holding

2.3. Supply

2.5. Other activities(s): Przechowywanie i dystrybucja produktów leczniczych dla Krajowego Centrum ds. AIDS

3. MEDICINAL PRODUCTS WITH ADDITIONAL REQUIREMENTS

3.3. Cold chain products(requiring low temperature handling)

3.4. Other products: 3.4.1, 3.4.4, 3.4.6

Any restrictions or clarifying remarks (for all users): Hurtownia prowadzi obrót produktami leczniczymi, dla których podmiotami odpowiedzialnymi są:
1. JANSSEN-CILAGINTERNATIONAL NV, BELGIA
2 JANSSEN BIOLOGICS B.V., HOLANDIA
3. UAB JOHNSON&JOHNSON LITWA
4. GRUNENTHAL GMBH, NIEMCY
5. BIOGEN IDEC LTD, WIELKA BRYTANIA.

*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	GIF-N-411/1029/1-3/TL/16
	Page 1

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