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RTF Template

Chief Pharmaceutical Inspectorate

UNION FORMAT FOR A WHOLESALE DISTRIBUTION AUTHORISATION

1. Authorisation Number	:	GIF-N-4111/2/AR/10
2. Name of Authorisation Holder	:	GEDEON RICHTER POLSKA Sp. z o.o.
3. Address(es) of Site(s)	:	Graniczna 35 / magazyn nr 81, Grodzisk Mazowiecki, mazowieckie, 05-825, Poland

4. Legally registered address of Authorisation Holder	:	Poniatowskiego 5, Grodzisk Mazowiecki, mazowieckie, 05-825, 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	:	2010-01-08
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

, Graniczna 35 / magazyn nr 81, Grodzisk Mazowiecki, mazowieckie, 05-825, 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

2.5. Other activities(s): *Patrz Zastrzeżenia - Uwaga 2.5

3. MEDICINAL PRODUCTS WITH ADDITIONAL REQUIREMENTS

3.4. Other products: 3.4.6

Any restrictions or clarifying remarks (for all users): * Uwaga 2.5 Zakup, przechowywanie i wydawanie referencyjnych produktów leczniczych na potrzeby działalności Pionu Rozwoju Produktów Gedeon Richter Polska Sp. z o.o. oraz zakup, przechowywanie i sprzedaż referencyjnych produktów leczniczych na rzecz Chemical Works of Gedeon Richter Plc Budapest, Hungary (z przeznaczeniem na potrzeby Pionu Rozwoju R&D Gedeon Richter Plc).

Hurtownia Farmaceutyczna GEDEON RICHTER Polska Sp. z o.o. prowadzi obrót hurtowy wyłącznie produktami leczniczymi, dla których podmioty należące do grupy kapitałowej GEDEON RICHTER są podmiotami odpowiedzialnymi bądź przedstawicielami podmiotów odpowiedzialnych. Zastrzeżenie powyższe nie dotyczy produktów leczniczych nabywanych przez Hurtownia Farmaceutyczna GEDEON RICHTER Polska Sp. z o.o. na potrzeby działalności określonych w pkt.2 ppkt.2.5 niniejszego Zezwolenia.

*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-4111/2/AR/10
	Page 1

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