National Authority of Medicines and Health Products, I.P.
UNION FORMAT FOR A WHOLESALE DISTRIBUTION AUTHORISATION
1. Authorisation Number
:
A075/14/H/004/2022
2. Name of Authorisation Holder
Gide Farma Produtos Farmaceuticos Lda.
(ORG-100002350 / LOC-100001291)
3. Address(es) of Site(s)
Rua Dos Tractores N 647, Jardia, Alto Estanqueiro-Jardia, 2870-607, Portugal
4. Legally registered address of Authorisation Holder
Estrada Do Casal Do Canas 6, Carnaxide, 2790-007
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
2022-02-07
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
SCOPE OF WHOLESALE DISTRIBUTION AUTHORISATION
Name and address of the site: Gide Farma Produtos Farmaceuticos Lda.
(ORG-100002350 / LOC-100065079)
, Rua Dos Tractores N 647, Jardia, Alto Estanqueiro-Jardia, 2870-607, Portugal
Human medicinal products
1.1. with a Marketing Authorisation in EEA country(s)
2.1. Procurement
2.2. Holding
2.3. Supply
2.4. Export
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 Authorised Site, regarding a toponymy change in the Address of the Site.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
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