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RTF Template

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

UNION FORMAT FOR A WHOLESALE DISTRIBUTION AUTHORISATION

Human medicinal products

1. Authorisation Number	:	A018/20/H/003/2022
2. Name of Authorisation Holder	:	Therafuture Medical Lda. (ORG-100037143 / LOC-100068276)
3. Address(es) of Site(s)	:	Rua Quinta Do Pinheiro N 5, Alverca Do Ribatejo, 2615-184, Portugal

4. Legally registered address of Authorisation Holder	:	Avenida Da Republica 50, Lisbon, 1050-196
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	:	2022-02-16
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: Therafuture Medical Lda.

(ORG-100037143 / LOC-100062869)

, Rua Quinta Do Pinheiro N 5, Alverca Do Ribatejo, 2615-184, Portugal

Human medicinal products

1. MEDICINAL PRODUCTS

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

1.2. without a Marketing Authorisation in the EEA and intended for EEA market

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

3.1.3. Immunological medicinal products

3.1.4. Radiopharmaceuticals (including radionuclide kits)

3.3. Cold chain products(requiring low temperature handling)

3.4. Other products: Investigational medicinal products.

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

This Wholesale Distribution Authorisation does not cover the supply of medicines under the scope of article 2 of the Commission Delegated Regulation (EU) 2016/161 of 2 October 2015.

Complete Legal Address: Avenida da República, n.º 50, 2.º andar - 1050-196 Lisboa.

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

*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	A018/20/H/003/2022
	Page 1

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