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RTF Template

National Authority Of Medicines And Health Products

UNION FORMAT FOR A WHOLESALE DISTRIBUTION AUTHORISATION

Human medicinal products

1. Authorisation Number	:	A015/19/H/004/2023
2. Name of Authorisation Holder	:	Alphega Lda. (ORG-100036000 / LOC-100056973)
3. Address(es) of Site(s)	:	Rua Do Engenheiro Ferreira Dias 738, Porto, 4100-246, Portugal

4. Legally registered address of Authorisation Holder	:	Rua Do Engenheiro Ferreira Dias 728 3º Piso, Porto, 4149-014
5. Scope of authorisation (complete for each site under 4)	:	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 wholesaling authorisation	:	Confidential, Confidential
8. Signature	:
9. Date	:	2023-08-10
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: Alphega Lda.

(ORG-100036000 / LOC-100081040)

, Rua Do Engenheiro Ferreira Dias 738, Porto, 4100-246, Portugal

Human medicinal products

1. MEDICINAL PRODUCTS

1.1. with a Marketing Authorisation in EEA country(s)

2. AUTHORISED WHOLESALE DISTRIBUTION OPERATIONS

2.1. Procurement

2.2. Holding

2.3. Supply

3. MEDICINAL PRODUCTS WITH ADDITIONAL REQUIREMENTS

3.1.3. Immunological medicinal products

3.3. Cold chain products(requiring low temperature handling)

Any restrictions or clarifying remarks (for all users): WDA scope activity - Wholesale Distributor.

Complete Legal Address: Rua Engenheiro Ferreira Dias, n.º 728, 3.º Piso Sul - 4149-014 Porto

Complete Site Address: Rua Engenheiro Ferreira Dias, n.º 738 - 4149-014 Porto

Transfer of Facilities.

*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

Union Format for a Wholesale Distribution Authorisation	A015/19/H/004/2023
	Page 1

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