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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	:	A036/13/H/006/2023
2. Name of Authorisation Holder	:	Labesfal Farma Produtos Farmaceuticos Lda. (ORG-100002939 / LOC-100043432)
3. Address(es) of Site(s)	:	Avenida Doutor Afonso Costa 1370, Campo De Besteiros, 3465-051, Portugal

4. Legally registered address of Authorisation Holder	:	Rua Dom Luis De Noronha 4 7, Lisbon, 1050-072
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	:	2023-02-08
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: Labesfal Farma Produtos Farmaceuticos Lda.

(ORG-100002939 / LOC-100000244)

, Avenida Doutor Afonso Costa 1370, Campo De Besteiros, 3465-051, Portugal

Human medicinal products

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

3.1.3. Immunological medicinal products

3.3. Cold chain products(requiring low temperature handling)

3.4. Other products: Herbal and Homeopathic medicinal products

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

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

Updating of the Annex 3 regarding a change of the Responsible Person.

*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	A036/13/H/006/2023
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