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RTF Template

Danish Medicines Agency

UNION FORMAT FOR A WHOLESALE DISTRIBUTION AUTHORISATION

Human medicinal products and Veterinary medicinal products

1. Authorisation Number	:	104423
2. Name of Authorisation Holder	:	Matas Operations A/S (ORG-100020296 / LOC-100029059)
3. Address(es) of Site(s)	:	Roermosevej 1, Alleroed, 3450, Denmark

4. Legally registered address of Authorisation Holder	:	Roermosevej 1, Alleroed, 3450, Denmark
5. Scope of authorisation	:	ANNEX 1
6. Legal basis of authorisation	:	Art. 77(1) of Directive 2001/83/EC Art. 99 of Regulation (EU) 2019/6
7. Name of responsible officer of the competent authority of the member state granting the wholesale distribution authorisation	:	Confidential, Confidential
8. Signature	:
9. Date	:	2025-03-14
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: Matas Operations A/S

(ORG-100020296 / LOC-100029059)

, Roermosevej 1, Alleroed, 3450, Denmark

Human medicinal products

Veterinary 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

2.2. Holding

2.3. Supply

2.4. Export

3. MEDICINAL PRODUCTS WITH ADDITIONAL REQUIREMENTS

3.3. Other products: (please specify here or make a reference to Annex 5) Homeopathic products

Any restrictions or clarifying remarks (for all users): 2.4: Distribution to Greenland: Herbal medicinal products, homeopathic products, high-dose vitamins and minerals. Distribution to the Faroe Islands: Herbal medicinal products, high-dose vitamins and minerals.

Union Format for a Wholesale Distribution Authorisation	104423
	Page 1

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