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RTF Template

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

UNION FORMAT FOR A WHOLESALE DISTRIBUTION AUTHORISATION

1. Authorisation Number	:	A016/21/H/001/2021
2. Name of Authorisation Holder	:	Gameiros, Material Clínico, Lda.
3. Address(es) of Site(s)	:	Rua da Sismaria, Lote 26, Zona Industrial Cova das Faias, Marrazes, Leiria, 2415-809 Leiria, Portugal

4. Legally registered address of Authorisation Holder	:	Avenida Onze de Julho, n.º 650, Letra B, Memória, Vila Nova de Ourém, 2435-809 Espite, 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	:	2021-07-29
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: Gameiros, Material Clínico, Lda.

, Rua da Sismaria, Lote 26, Zona Industrial Cova das Faias, Marrazes, Leiria, 2415-809 Leiria, Portugal

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

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: Homeopathic and Herbal medicinal products

Any restrictions or clarifying remarks (for all users): National legal basis of authorisation: Art. 94.º of Decree-law 176/2006, of 30th August.

WDA scope activity - Wholesale Distributor.

*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	A016/21/H/001/2021
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