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Warning Messages

The site AJ Vaccines A/S is under Compliance Management : This GMP certificate covers BCG Vaccine (filling and lyophilization in building 88). The certificate is issued with administrative action described within the procedure for compliance management in the Compilation of Union Procedures. The certificate is valid for 18 months from the date of inspection.

RTF Template

Danish Medicines Agency

UNION FORMAT FOR A WHOLESALE DISTRIBUTION AUTHORISATION

Human medicinal products and Veterinary medicinal products

1. Authorisation Number	:	105268
2. Name of Authorisation Holder	:	AJ Vaccines A/S (ORG-100007001 / LOC-100011316)
3. Address(es) of Site(s)	:	Artillerivej 5, Copenhagen S, 2300, Denmark

4. Legally registered address of Authorisation Holder	:	Artillerivej 5, Copenhagen S, 2300
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	:	2026-05-08
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: AJ Vaccines A/S

(ORG-100007001 / LOC-100011316)

, Artillerivej 5, Copenhagen S, 2300, Denmark

Human medicinal products

Veterinary 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

3.2. 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) Investigational medicinal products

Any restrictions or clarifying remarks (for all users): Medicinal products received from third countries must only be held at bonded warehouses with a valid WDA and must only be exported to third countries

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

Union Format for a Wholesale Distribution Authorisation	105268
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