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Information Messages

The WDA has been withdrawn, withdrawn date is: 2025-05-23

RTF Template

Competent Regional Authority. Dirección General de Farmacia y Productos Sanitarios. Comunidad Valenciana. España.

UNION FORMAT FOR A WHOLESALE DISTRIBUTION AUTHORISATION

1. Authorisation Number	:	V-31-AM
2. Name of Authorisation Holder	:	ORTOVAL, S.A.
3. Address(es) of Site(s)	:	Avenida Ausias March, 42, bajo, València, Valencia, 46026, Spain

4. Legally registered address of Authorisation Holder	:	AVENIDA AUSIAS MARCH, 42, 1º, VALENCIA, Valencia, 46026, Spain
5. Scope of authorisation	:	ANNEX 1
6. Legal basis of authorisation	:
7. Name of responsible officer of the competent authority of the member state granting the wholesale distribution authorisation	:	Confidential, Confidential
8. Signature	:
9. Date	:	2018-08-22
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: ORTOVAL, S.A.

, Avenida Ausias March, 42, bajo, València, Valencia, 46026, Spain

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

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

3.1.2. Medicinal products derived from blood

3.1.3. Immunological medicinal products

3.1.4. Radiopharmaceuticals (including radionuclide kits)

3.2. Medicinal gases

3.3. Cold chain products(requiring low temperature handling)

Reason for Withdrawing:

This authorisation has been withdrawn.

Esta autorización ha sido revocada.

Union Format for a Wholesale Distribution Authorisation	V-31-AM
	Page 1

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