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Information Messages

The WDA has been withdrawn, withdrawn date is: 2026-11-03

RTF Template

National Centre For Public Health And Pharmacy

UNION FORMAT FOR A WHOLESALE DISTRIBUTION AUTHORISATION

Human medicinal products

1. Authorisation Number	:	HU-D-TEVA
2. Name of Authorisation Holder	:	Teva Gyogyszergyar Zrt. (ORG-100000650 / LOC-100062772)
3. Address(es) of Site(s)	:	Vasút u. 11. (Shark Park) SPH4 és SPH5 Raktárépület, 2-14. kapuk, Budaörs, 2040, Hungary

4. Legally registered address of Authorisation Holder	:	Sph4 Es Sph5 Raktarepulet 2-14 Kapuk, Vasut Utca 11, Budaors, 2040
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	:	2026-05-11
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: Teva Gyógyszergyár Zrt.

, Vasút u. 11. (Shark Park) SPH4 és SPH5 Raktárépület, 2-14. kapuk, Budaörs, 2040, Hungary

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) Homeopathic medicinal products, Materials for preparation of „magistral formula" (human medicinal

Any restrictions or clarifying remarks (for all users): Other authorized products with additional requirements:
2.2 Holding
2.2.1 Room temperature (15-25°C) store-house
2.2.2 Cool temperature (8-15°C) warehouse SHP5, room C29A; warehouse SHP5, room C29B
2.2.3 Materials for preparation of „magistral formula" (2-8°C)
3. Other permitted medicinal products
3.3.1. Homeopathic medicinal products
3.3.2. Materials for preparation of „magistral formula" (human medicinal products)

Additional provisions based on national requirements:
Responsible Person is: diploma No is:
Dr. Alapi Anikó 1/1990 (pharmacist)
Dr. Nagy-Kolláth Krisztina Julianna 50/2001 (pharmacist)

*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.

Reason for Withdrawing:

Administration error.

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

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