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RTF Template

National Public Health And Pharmaceutical Centre

UNION FORMAT FOR A WHOLESALE DISTRIBUTION AUTHORISATION

Human medicinal products

1. Authorisation Number	:	HU-D-MEEK
2. Name of Authorisation Holder	:	Medinspect Kft. (ORG-100018739 / LOC-100027531)
3. Address(es) of Site(s)	:	Csipanyok Utca 2, Fot, 2151, Hungary

4. Legally registered address of Authorisation Holder	:	Csipanyok Utca 2, Fot, 2151
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	:	2024-05-06
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: Medinspect Kft.

(ORG-100018739 / LOC-100027531)

, Csipanyok Utca 2, Fot, 2151, Hungary

Human medicinal products

1. MEDICINAL PRODUCTS

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

1.2. without a Marketing Authorisation in the EEA and intended for EEA market

1.3. without a Marketing Authorisation 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

3.1.1. Narcotic or psychotropic products

3.1.3. Immunological medicinal products

3.1.4. Radiopharmaceuticals (including radionuclide kits)

3.3. Cold chain products(requiring low temperature handling)

3.4. Other products: see in the remark

Any restrictions or clarifying remarks (for all users): 2. Authorised Wholesale Distribution Operation
2.2 Holding
2.2.1. Room temperature (15-25°C) store-house
2.2.2. Cold chain (2-8°C) store-house

3.Medicinal products with additional requirements
3.4. Other Products
3.4.1. Radiopharmaceuticals delivered frozen in a refrigerated packaging containing dry ice and should be stored frozen at ≤ -18°C

Name(s) of responsible person(s):
Dr. Pereczes János 77/2000(pharmacist)
Dr. Bába Orsolya 1/2021/GY (pharmacist)

*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

Union Format for a Wholesale Distribution Authorisation	HU-D-MEEK
	Page 1

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