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Information Messages

The WDA has been withdrawn, withdrawn date is: 2025-01-15

RTF Template

National Authority of Medicines and Health Products, I.P.

UNION FORMAT FOR A WHOLESALE DISTRIBUTION AUTHORISATION

1. Authorisation Number	:	A001/17/H/002/2020
2. Name of Authorisation Holder	:	Kniphar - Produtos Farmacêuticos, Lda.
3. Address(es) of Site(s)	:	Rua Manuel Assunção Falcão, n.º 321 (Lote n.º 12), Maia, 4475-041 Maia, Portugal

4. Legally registered address of Authorisation Holder	:	Restelo Business Center, Avenida Ilha da Madeira, n.º 35 L - 4 A, Lisboa, 1400-203 Lisboa, 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	:	2020-06-17
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: Kniphar - Produtos Farmacêuticos, Lda.

, Rua Manuel Assunção Falcão, n.º 321 (Lote n.º 12), Maia, 4475-041 Maia, Portugal

1. 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. AUTHORISED WHOLESALE DISTRIBUTION OPERATIONS

2.1. Procurement

2.2. Holding

2.3. Supply

2.4. Export

3. MEDICINAL PRODUCTS WITH ADDITIONAL REQUIREMENTS

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: Cytostatic, Herbal, Homeopathic and Similar biological Medicinal Products - Immunomodulators

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.

The Authorisation number A001/17/H/002/2020 replaces the previous one with the Authorisation number A001/17/H/001/2017, of 2017-01-03.

Reason for Withdrawing:

Transfer of Facilities.

Union Format for a Wholesale Distribution Authorisation	A001/17/H/002/2020
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