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RTF Template

Swedish Medical Products Agency

UNION FORMAT FOR A WHOLESALE DISTRIBUTION AUTHORISATION

Human medicinal products

1. Authorisation Number	:	SE-H-WDA-24-004894
2. Name of Authorisation Holder	:	Orifarm Generics AB (ORG-100005764 / LOC-100086883)
3. Address(es) of Site(s)	:	Klara Sodra Kyrkogata 1, Stockholms Domkyrkofors., Stockholm, 111 52, Sweden

4. Legally registered address of Authorisation Holder	:	P. O. Box 56048, Stockholm, 102 17
5. Scope of authorisation	:	ANNEX 1
6. Legal basis of authorisation	:	Art. 77(1) of Directive 2001/83/EC
7. Name of responsible officer of the competent authority of the member state granting the wholesale distribution authorisation	:	Confidential, Confidential
8. Signature	:
9. Date	:	2025-05-12
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: Orifarm Generics AB

(ORG-100005764 / LOC-100088966)

, Klara Sodra Kyrkogata 1, Stockholms Domkyrkofors., Stockholm, 111 52, Sweden

Human medicinal products

1. MEDICINAL PRODUCTS

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

2. AUTHORISED WHOLESALE DISTRIBUTION OPERATIONS

2.1. Procurement

2.3. Supply

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): Secondary business name: Orifarm Healthcare

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

Union Format for a Wholesale Distribution Authorisation	SE-H-WDA-24-004894
	Page 1

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