National Authority of Medicines and Health Products, I.P.
UNION FORMAT FOR A WHOLESALE DISTRIBUTION AUTHORISATION
1. Authorisation Number
:
A044/99/H/005/2021
2. Name of Authorisation Holder
Disfaport - Distribuidora de Produtos Farmacêuticos, S.A.
3. Address(es) of Site(s)
Parque Empresarial da Granja-Vialonga, n.º 17, 18, 19 e 20, Casal do Bagulho - Granja de Alpriate, Vila Franca de Xira, 2625-607 Vialonga, Portugal
4. Legally registered address of Authorisation Holder
Parque Empresarial da Granja-Vialonga, n.º 18, Casal do Bagulho - Granja de Alpriate, Vila Franca de Xira, 2625-607 Vialonga, 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
2021-05-28
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: Disfaport - Distribuidora de Produtos Farmacêuticos, S.A.
, Parque Empresarial da Granja-Vialonga, n.º 17, 18, 19 e 20, Casal do Bagulho - Granja de Alpriate, Vila Franca de Xira, 2625-607 Vialonga, Portugal
1.1. with a Marketing Authorisation in EEA country(s)
1.2. without a Marketing Authorisation in the EEA and intended for EEA market
1.3. without a Marketing Authorisation in the EEA and intended for exportation
2.1. Procurement
2.2. Holding
2.3. Supply
2.4. Export
3.1.1. Narcotic or psychotropic products
3.1.2. Medicinal products derived from blood
3.1.3. Immunological medicinal products
3.3. Cold chain products(requiring low temperature handling)
3.4. Other products: Herbal and Homeopathic medicinal products.
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 and 3 PL (Third Party Logistics Providers).Updating of the Annex 1 regarding the inclusion of the Narcotic or psychotropic products. The Authorisation number A044/99/H/005/2021 replaces the previous one with the Authorisation number A044/99/H/004/2020, of 2020-05-19.
Reason for Withdrawing:
Updating the Authorisation Number, regarding a renewal of the latest Inspection Date of the Certificate of GDP Compliance.
Union Format for a Wholesale Distribution Authorisation
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