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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	:	A010/19/H/001/2019
2. Name of Authorisation Holder	:	MTPH - Pharmaceutical, Lda.
3. Address(es) of Site(s)	:	Quinta do Pinheiro, n.º 1, Vila Franca de Xira, 2615-001 Alverca do Ribatejo, Portugal

4. Legally registered address of Authorisation Holder	:	Avenida D. João II, n.º 50, Edifício Mar Vermelho, Parque das Nações, Lisboa, 1990-095 Lisboa, 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	:	2019-07-02
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: MTPH - Pharmaceutical, Lda.

, Quinta do Pinheiro, n.º 1, Vila Franca de Xira, 2615-001 Alverca do Ribatejo, 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

3.1.1. Narcotic or psychotropic products

3.1.3. Immunological medicinal products

3.3. Cold chain products(requiring low temperature handling)

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

*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	A010/19/H/001/2019
	Page 1

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