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RTF Template

Bulgarian Drug Agency

UNION FORMAT FOR A WHOLESALE DISTRIBUTION AUTHORISATION

Human medicinal products

1. Authorisation Number	:	BG/WDA/MP-0591
2. Name of Authorisation Holder	:	Alta Pharmaceuticals Ltd. (ORG-100021579 / LOC-100066641)
3. Address(es) of Site(s)	:	Building 2 And Building 1, Bulevard Slivnitsa 578, Vrabnitsa District, Sofia, Oblast Sofia Grad, 1331, Bulgaria Bulevard Nikola Petkov 52, Stara Zagora, Oblast Stara Zagora, 6009, Bulgaria Potsdam Bulevard 11, Ruse, 7005, Bulgaria Olimpi Panov 17, Lozishte Area, Slivnitsa, 2200, Bulgaria

4. Legally registered address of Authorisation Holder	:	Building 2 And Building 1, Bulevard Slivnitsa 578, Vrabnitsa District, Sofia, Oblast Sofia Grad, 1331
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	:	2025-09-23
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: Alta Pharmaceuticals Ltd.

(ORG-100021579 / LOC-100066641)

, Building 2 And Building 1, Bulevard Slivnitsa 578, Vrabnitsa District, Sofia, Oblast Sofia Grad, 1331, Bulgaria

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

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

3.3. Other products: (please specify here or make a reference to Annex 5) medicinal products derived from blood, immunological medicinal products

Name and address of the site: Alta Pharmaceuticals Ltd.

(ORG-100021579 / LOC-100089702)

, Bulevard Nikola Petkov 52, Stara Zagora, Oblast Stara Zagora, 6009, Bulgaria

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

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) medicinal products derived from blood, immunological medicinal products

Name and address of the site: Alta Pharmaceuticals Ltd.

(ORG-100021579 / LOC-100089703)

, Potsdam Bulevard 11, Ruse, 7005, Bulgaria

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

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) medicinal products derived from blood, immunological medicinal products

Name and address of the site: Alta Pharmaceuticals Ltd.

(ORG-100021579 / LOC-100099273)

, Olimpi Panov 17, Lozishte Area, Slivnitsa, 2200, Bulgaria

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

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) medicinal products derived from blood, immunological medicinal products

*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	BG/WDA/MP-0591
	Page 1

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