National Authority of Medicines and Health Products, I.P.
UNION FORMAT FOR A WHOLESALE DISTRIBUTION AUTHORISATION
1. Authorisation Number
:
A008/03/H/002/2019
2. Name of Authorisation Holder
Vipfarma - Logística Farmacêutica, S.A.
3. Address(es) of Site(s)
Rua das Indústrias, n.º 18, Mafra, 2665-601 Venda do Pinheiro, Portugal
4. Legally registered address of Authorisation Holder
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
2019-12-12
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: Vipfarma - Logística Farmacêutica, S.A.
, Rua das Indústrias, n.º 18, Mafra, 2665-601 Venda do Pinheiro, 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
2.2. Holding
3.1.1. Narcotic or psychotropic products
3.1.2. Medicinal products derived from blood
3.1.3. Immunological medicinal products
3.1.4. Radiopharmaceuticals (including radionuclide kits)
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 - 3 PL (Third Party Logistics Providers).Updating of the WDA Header regarding a change in the legal name and in the legal address of the Authorisation Holder. The Authorisation number A008/03/H/002/2019 replaces the previous one with the Authorisation number A008/H/001/2003, of 2003-02-27.
Reason for Withdrawing:
Updating of the Annex 1 regarding the inclusion of the cytostatic; biological; Immunomodulators and investigational medicinal products.
Union Format for a Wholesale Distribution Authorisation
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