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Information Messages

The WDA has been withdrawn, withdrawn date is: 2024-10-22

RTF Template

Medicines Authority

UNION FORMAT FOR A WHOLESALE DISTRIBUTION AUTHORISATION

Human medicinal products

1. Authorisation Number	:	WL 014
2. Name of Authorisation Holder	:	Alfred Gera & Sons Ltd.
3. Address(es) of Site(s)	:	10 Triq Il-Masgar, Hal Qormi, QRM 3217, Malta 2 Nagoya Garage, Triq Il-Belt Valletta, Hal Qormi, QRM 3610, Malta

4. Legally registered address of Authorisation Holder	:	10, Triq il-Masgar, Qormi, QRM 3217
5. Scope of authorisation (complete for each site under 4)	:	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 wholesaling authorisation	:	Confidential, Confidential
8. Signature	:
9. Date	:	2022-08-11
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: Alfred Gera & Sons Limited

(ORG-100009575 / LOC-100016054)

, 10 Triq Il-Masgar, Hal Qormi, QRM 3217, Malta

Human medicinal products

1. MEDICINAL PRODUCTS

1.1. with a Marketing Authorisation 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

3.1.1. Narcotic or psychotropic products

3.1.2. Medicinal products derived from blood

3.1.3. Immunological medicinal products

3.3. Cold chain products(requiring low temperature handling)

Any restrictions or clarifying remarks (for all users): The two sites pertaining to this company are interconnected and operate as one.

Name and address of the site: Alfred Gera & Sons Limited

(ORG-100009575 / LOC-100070271)

, 2 Nagoya Garage, Triq Il-Belt Valletta, Hal Qormi, QRM 3610, Malta

Human medicinal products

1. MEDICINAL PRODUCTS

1.1. with a Marketing Authorisation 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

3.1.1. Narcotic or psychotropic products

3.1.2. Medicinal products derived from blood

3.1.3. Immunological medicinal products

3.3. Cold chain products(requiring low temperature handling)

Any restrictions or clarifying remarks (for all users): The two sites pertaining to this company are interconnected and operate as one.

*Art 5 of Directive 2001/83/EC or Art 83 of Regulation EC/726/2004

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

Reason for Withdrawing:

Adminsitartive change in legal address and site street address

Union Format for a Wholesale Distribution Authorisation	WL 014
	Page 1

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