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Information Messages

The WDA has been withdrawn, withdrawn date is: 2025-07-03

RTF Template

National Authority of Medicines and Health Products, I.P.

UNION FORMAT FOR A WHOLESALE DISTRIBUTION AUTHORISATION

1. Authorisation Number	:	A015/11/H/003/2021
2. Name of Authorisation Holder	:	Teva Pharma - Produtos Farmacêuticos, Lda.
3. Address(es) of Site(s)	:	Rua dos Tractores, n.º 647, Terminal 1 e 4, Alto do Estanqueiro-Jardia, Montijo, 2870-607 Montijo, Portugal

4. Legally registered address of Authorisation Holder	:	Lagoas Park, Edifício 5 A, Piso 2, Oeiras, 2740-245 Porto Salvo, Portugal
5. Scope of authorisation	:	ANNEX 1
6. Legal basis of authorisation	:
7. Name of responsible officer of the competent authority of the member state granting the wholesale distribution authorisation	:	Confidential, Confidential
8. Signature	:
9. Date	:	2021-10-06
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: Teva Pharma - Produtos Farmacêuticos, Lda.

, Rua dos Tractores, n.º 647, Terminal 1 e 4, Alto do Estanqueiro-Jardia, Montijo, 2870-607 Montijo, Portugal

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

3. MEDICINAL PRODUCTS WITH ADDITIONAL REQUIREMENTS

3.1.1. Narcotic or psychotropic products

3.1.3. Immunological medicinal products

3.3. Cold chain products(requiring low temperature handling)

Any restrictions or clarifying remarks (for all users): National legal basis of authorisation: Art. 94.º of Decree-law 176/2006, of 30th August.

WDA scope activity - Wholesale Distributor.

Updating of the Authorised Site, regarding a toponymy change in the Address of the Site.

The Authorisation number A015/11/H/003/2021 replaces the previous one with the Authorisation number A015/11/H/002/2021, of 2021-04-01.

Reason for Withdrawing:

Updating WDA, regarding a a renewal of the latest Inspection Date of the Certificate of GDP Compliance.

Union Format for a Wholesale Distribution Authorisation	A015/11/H/003/2021
	Page 1

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