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RTF Template

Spanish Agency Of Medicines And Medical Devices

UNION FORMAT FOR A WHOLESALE DISTRIBUTION AUTHORISATION

Human medicinal products

1. Authorisation Number	:	AA-014-ES
2. Name of Authorisation Holder	:	Botiquin Sans S.L. (ORG-100020579 / LOC-100079391)
3. Address(es) of Site(s)	:	Calle Bergueda 16-18, Poligono Industrial Pla De La Brugera, Castellar Del Valles, Barcelona, 08211, Spain

4. Legally registered address of Authorisation Holder	:	Calle De Santa Virgilia No 20b, Madrid, 28033
5. Scope of authorisation	:	ANNEX 1
6. Legal basis of authorisation	:	Real Decreto 782/2013, de 11 de octubre
7. Name of responsible officer of the competent authority of the member state granting the wholesale distribution authorisation	:	Confidential, Confidential
8. Signature	:
9. Date	:	2025-12-17
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: Botiquin Sans S.L.

(ORG-100020579 / LOC-100079298)

, Calle Bergueda 16-18, Poligono Industrial Pla De La Brugera, Castellar Del Valles, Barcelona, 08211, Spain

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

2.5. Other activities(s): (please specify) Almacén de medicamentos bajo control o vigilancia aduanera/ Custom warehouse

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

Any restrictions or clarifying remarks (for all users): 3.1.1: Sólo almacena Psicótropos.

3.1.1: Sólo almacena Psicótropos.

*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	AA-014-ES
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