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Information Messages

The WDA has been withdrawn, withdrawn date is: 2024-11-15

RTF Template

Chief Pharmaceutical Inspectorate

UNION FORMAT FOR A WHOLESALE DISTRIBUTION AUTHORISATION

1. Authorisation Number	:	GIF-N-411/699/MSH/13
2. Name of Authorisation Holder	:	TEVA OPERATIONS POLAND Spółka z ograniczoną odpowiedzialnością
3. Address(es) of Site(s)	:	44C, Kopytów, Błonie, mazowieckie, 05-870, Poland

4. Legally registered address of Authorisation Holder	:	Emilii Plater 53, Warszawa, mazowieckie, 00-113, 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	:	2013-04-10
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

, 44C, Kopytów, Błonie, 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

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, 3.4.7

Any restrictions or clarifying remarks (for all users): Asortyment ograniczony do produktów leczniczych nabywanych przez TEVA Operations Poland sp. z o.o. od wytwórców i przedsiębiorców posiadających zezwolenie na prowadzenie hurtowni farmaceutycznej z grupy kapitałowej TEVA oraz produktów leczniczych, dla których podmiotem odpowiedzialnym lub przedstawicielem podmiotu odpowiedzialnego jest podmiot z grupy kapitałowej Teva, oraz produktów wytwarzanych przez Teva Operations Poland sp. z o.o.

*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

Reason for Withdrawing:

Zezwolenie wygaszone z dniem 9.10.2024/WDA withdrawn on 9 October 2024.

Union Format for a Wholesale Distribution Authorisation	GIF-N-411/699/MSH/13
	Page 1

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