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Information Messages

The WDA has been withdrawn, withdrawn date is: 2025-06-01

RTF Template

National Authority Of Medicines And Health Products

UNION FORMAT FOR A WHOLESALE DISTRIBUTION AUTHORISATION

Human medicinal products

1. Authorisation Number	:	A009/16/H/007/2023
2. Name of Authorisation Holder	:	Helm Portugal Unipessoal Lda. (ORG-100004498 / LOC-100075893)
3. Address(es) of Site(s)	:	Rua Dos Tractores, Jardia, Alto Estanqueiro-Jardia, 2870-607, Portugal

4. Legally registered address of Authorisation Holder	:	Avenida Vitor Figueiredo N 4 Piso 1, Carnaxide, 2790-255
5. Scope of authorisation	:	ANNEX 1
6. Legal basis of authorisation	:	Art. 77(1) of Directive 2001/83/EC National legal basis of authorisation: Art. 94.º of Decree-law 176/2006, of 30th August.
7. Name of responsible officer of the competent authority of the member state granting the wholesale distribution authorisation	:	Confidential, Confidential
8. Signature	:
9. Date	:	2023-01-16
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: Helm Portugal Unipessoal Lda.

(ORG-100004498 / LOC-100007299)

, Rua Dos Tractores, Jardia, Alto Estanqueiro-Jardia, 2870-607, Portugal

Human medicinal products

1. MEDICINAL PRODUCTS

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

1.3. without a Marketing Authorisation in the EEA and intended for exportation

2. AUTHORISED WHOLESALE DISTRIBUTION OPERATIONS

2.1. Procurement

2.2. Holding

2.3. Supply

2.4. Export

3. MEDICINAL PRODUCTS WITH ADDITIONAL REQUIREMENTS

3.1.1. Narcotic or psychotropic products

3.3. Cold chain products(requiring low temperature handling)

Any restrictions or clarifying remarks (for all users): WDA scope activity - Wholesale Distributor.

Updating of the WDA Header regarding a change in the legal address of the Authorisation Holder.

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

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	A009/16/H/007/2023
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