National Authority Of Medicines And Health Products
UNION FORMAT FOR A WHOLESALE DISTRIBUTION AUTHORISATION
1. Authorisation Number
:
A011/24/H/001/2024
2. Name of Authorisation Holder
Canapac Lda.
(ORG-100050257 / LOC-100087723)
3. Address(es) of Site(s)
Rua 3b Lote 48, Zona Industrial De Cantanhede, Cantanhede, 3060-197, Portugal
4. Legally registered address of Authorisation Holder
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
2024-06-19
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: Canapac Lda.
, Rua 3b Lote 48, Zona Industrial De Cantanhede, Cantanhede, 3060-197, Portugal
Human 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
2.1. Procurement
2.2. Holding
2.3. Supply
2.4. Export
Any restrictions or clarifying remarks (for all users): WDA scope activity - Wholesale Distributor.Updating of the Annex 5 regarding the inclusion of Substances and preparations based on cannabisplant for medicinal purposes approved as finished products.
Reason for Withdrawing:
Updating the Annex 1 of the WDA regarding a change in the WDA scope activity.
Union Format for a Wholesale Distribution Authorisation
Page 1
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