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Information Messages

The WDA has been withdrawn, withdrawn date is: 2024-10-24

RTF Template

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

UNION FORMAT FOR A WHOLESALE DISTRIBUTION AUTHORISATION

1. Authorisation Number	:	A008/17/H/001/2017
2. Name of Authorisation Holder	:	Nayeris - Trade and Logistics, 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	:	Estrada Nacional, n.º 120, Sítio do Bemparece, Aljezur, 8670-440 Aljezur, Portugal
5. Scope of authorisation (complete for each site under 4)	:	ANNEX 1
6. Legal basis of authorisation	:
7. Name of responsible officer of the competent authority of the member state granting the wholesaling authorisation	:	Confidential, Confidential
8. Signature	:
9. Date	:	2017-03-17
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: Nayeris - Trade and Logistics, 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

3.1.2. Medicinal products derived from blood

3.1.3. Immunological medicinal products

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.

*Art 5 of Directive 2001/83/EC or Art 83 of Regulation EC/726/2004

**Without prejudice to further authorisations as may be required according to national legislation

Reason for Withdrawing:

Updating of the WDA Header regarding a change in the legal address of the Authorisation Holder.

Transfer of Facilities.

Union Format for a Wholesale Distribution Authorisation	A008/17/H/001/2017
	Page 1

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