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RTF Template

National Authority Of Medicines And Health Products

UNION FORMAT FOR A WHOLESALE DISTRIBUTION AUTHORISATION

Human medicinal products

1. Authorisation Number	:	A004/25/H/001/2025
2. Name of Authorisation Holder	:	Fracht Portugal Unipessoal Lda. (ORG-100052286 / LOC-100092077)
3. Address(es) of Site(s)	:	Rua Quinta Do Pinheiro 5, Alverca Do Ribatejo, 2615-184, Portugal

4. Legally registered address of Authorisation Holder	:	Aviz Trade Center, Rua Do Engenheiro Ferreira Dias No 924 - L3, Porto, 4100-246, Portugal
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	:	2025-02-03
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: Fracht Portugal Unipessoal Lda.

(ORG-100052286 / LOC-100093979)

, Rua Quinta Do Pinheiro 5, Alverca Do Ribatejo, 2615-184, Portugal

Human medicinal products

1. MEDICINAL PRODUCTS

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

2. AUTHORISED WHOLESALE DISTRIBUTION OPERATIONS

2.2. Holding

3. MEDICINAL PRODUCTS WITH ADDITIONAL REQUIREMENTS

3.2. Products requiring low temperature handling

3.2.1. Temperatures between 2 to 8 °C

Any restrictions or clarifying remarks (for all users): WDA scope activity – 3 PL (Third Party Logistics Providers).

Complete Site Address: Quinta do Pinheiro, n.º 5 - 2615-184 Alverca do Ribatejo.

Union Format for a Wholesale Distribution Authorisation	A004/25/H/001/2025
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