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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	:	A022/10/H/003/2024
2. Name of Authorisation Holder	:	Propec Farmaceutica Lda. (ORG-100030819 / LOC-100088731)
3. Address(es) of Site(s)	:	Avenida Bufo Real N. 1065, Zona Industrial De Porto De Mos, Porto De Mos, 2480-407, Portugal

4. Legally registered address of Authorisation Holder	:	Avenida Bufo Real N. 1065, Zona Industrial De Porto De Mos, Porto De Mos, 2480-407, Portugal
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	:	2024-11-12
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: Propec Farmaceutica Lda.

(ORG-100030819 / LOC-100088731)

, Avenida Bufo Real N. 1065, Zona Industrial De Porto De Mos, Porto De Mos, 2480-407, Portugal

Human medicinal products

1. MEDICINAL PRODUCTS

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

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

1.3. without a Marketing Authorisation or registration 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. Narcotic or psychotropic products**

3.2. Products requiring low temperature handling

3.2.1. Temperatures between 2 to 8 °C

3.3. Other products: (please specify here or make a reference to Annex 5) Immunological; Radiopharmaceuticals (including radionuclide kits) and Cytotoxic 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 and a toponymy change in the legal address of the Authorisation Holder and in the Address of the Site.

*Art. 5 of Directive 2001/83/EC, Art. 83 of Regulation (EC) 726/2004 and Art. 110 of Regulation 2019/6.

**Without prejudice to further authorisations as may be required according to national legislation.

Union Format for a Wholesale Distribution Authorisation	A022/10/H/003/2024
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