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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	:	A004/24/H/001/2024
2. Name of Authorisation Holder	:	Synthir Pharma Unipessoal Lda. (ORG-100050222 / LOC-100087672)
3. Address(es) of Site(s)	:	Parque Industrial De Vialonga 25, Granja, Vialonga, 2625-607, PORTUGAL

4. Legally registered address of Authorisation Holder	:	Parque Industrial De Vialonga 25, Granja, Vialonga, 2625-607
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	:	2024-02-20
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: Synthir Pharma Unipessoal Lda.

(ORG-100050222 / LOC-100087672)

, Parque Industrial De Vialonga 25, Granja, Vialonga, 2625-607, 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

3.1.2. Medicinal products derived from blood

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: Herbal, Homeopathic, Cytotoxic, Immunomodulators and Biological medicinal products.

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

Complete Legal Address: Parque Empresarial Vialonga-Granja, n.º 25, Casal do Bagulho, Granja de
Alpriate - 2625-607 Vialonga.

Complete Site Address: Parque Empresarial Vialonga-Granja, n.º 24, 25, 35 e 36, Casal do Bagulho,
Granja de Alpriate - 2625-607 Vialonga.

*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	A004/24/H/001/2024
	Page 1

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