Sat 14 Nov 2026 18:25:14 BST

Search Company

OMS Organisation Identifier:

OMS Location Identifier:

NCA Reference Key:

Address:

Country:

Active Substance

New Active Substance

Search Site

Create Site

Update Site

Current data stored in EudraGMDP database

Current data stored in OMS

DUNS Number:

NCA Reference Key:

Site Name:

OMS Organisation Identifier:

OMS Location Identifier:

Address Line 1:

Address Line 2:

Address Line 3:

Address Line 4:

City:

County:

Postcode:

Country:

Additional Details on Units Inspected

Site under Compliance Management:

Compliance Management comments:

Characters remaining:4000/4000

Overwrite with current OMS data.:

New Active Substance Importation

Active Substance*

Active Substance (English):
Active Substance (NL):
NCA Reference Key:

3rd Country Manufacturer

3rd Country Manufacturer	OMS Location Identifier	OMS Organisation Identifier	Legal Address	NCA Reference Key	Confidential	Edit	Delete
No records found.

3rd Country Distributor

3rd Country Distributor	OMS Location Identifier	OMS Organisation Identifier	Legal Address	NCA Reference Key	Confidential	Edit	Delete
No records found.

RTF Template

Chief Pharmaceutical Inspectorate

UNION FORMAT FOR A WHOLESALE DISTRIBUTION AUTHORISATION

Human medicinal products

1. Authorisation Number	:	GIF-N-411/829/MSH/14
2. Name of Authorisation Holder	:	Bausch Health Poland Sp. z o.o. (ORG-100004636 / LOC-100055722)
3. Address(es) of Site(s)	:	Ul. Kosztowska 21, Myslowice, 41-409, Poland

4. Legally registered address of Authorisation Holder	:	Ul. Przemyslowa 2, Rzeszow, 35-105, Poland
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	:	2024-09-18
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: Bausch Health Poland Sp. z o.o.

(ORG-100004636 / LOC-100042453)

, Ul. Kosztowska 21, Myslowice, 41-409, Poland

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

3.2.2. Other temperatures: (please specify) od 8 do 15 °C

3.3. Other products: (please specify here or make a reference to Annex 5) 3.4.1 Cytotoxic medicinal products, 3.4.2 Dangerous medicinal products, 3.4.4 Medicinal products with very strong effect

Any restrictions or clarifying remarks (for all users): Pkt 3.4.2 z wyłączeniem produktów leczniczych żrących.
Obrót produktami leczniczymi ograniczony do produktów, dla których podmiotem odpowiedzialnym lub przedstawicielem podmiotu odpowiedzialnego jest podmiot z grupy kapitałowej Bausch Health. Hurtownia prowadzi także obrót produktami leczniczymi, dla których posiadaczami pozwolenia na dopuszczenie do obrotu są następujące podmioty: Alkaloid AD Skopje, Amicus Pharma d.o.o., Bausch & Lomb Swiss AG, Bionorica SE, Blue Bio Pharmaceuticals Ltd., Bradex S.A., Casen Recordati S.L., Curatis AG, Cyathus Exquirere Pharmaforschungs GmbH, DEMO S.A. Pharmaceutical Industry, EFFIK, Exeltis Poland Sp. z o.o., Grünenthal GmbH, Helsinn Birex Pharmaceuticals Ltd., Ipsen Consumer HealthCare, Ipsen Pharma, Ipsen Pharma Gmbh, Kyowa Kirin Holdings B.V., Lomapharm GmbH, Noridem Enterprises Ltd., Orexigen Therapeutics Ireland Limited, Photocure ASA, Promedika d.o.o., Recordati Ireland Ltd., Recordati S.p.A., Serb S.A.S."

*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	GIF-N-411/829/MSH/14
	Page 1

Loading, please wait