(logo) SÚKL

State Institute for Drug Control

Šrobarova 48, 100 41 Prague 10
Tel: +420 272 185 111
Fax: +420 271 732 377
E-mail: posta@sukl.cz
Web: www.sulk.cz

ACCORD HEALTHCARE POLSKA Sp. z o.o.

Taśmowa 7
02-677 Warsaw
Poland
Delivery address:
ACCORD HEALTHCARE LIMITED
Sage House, 319 Pinner Road
HA1 4HF North Harrow - Middlesex
United Kingdom

Reference Number
sukls353801/2018
Handled/Department
Dr. rer. Nat. Marcela Rybínová, Ph.D. / 643
Date
3.4.2019

NOTIFICATION
regarding the approval of the notified change to the registration of the medicinal product

The State Institute for Drug Control, with its headquarters in Prague 10 at Šrobárova 48 (hereinafter
referred to as the "Institute"), acting as the competent authority in accordance with Section 13(2)(a)(1) of
Act No. 378/2007 Coll., on Pharmaceuticals and Amendments to Some Related Acts (referred to as the
"Pharmaceuticals Act"), as amended, hereby approves the notified change to the registration of the
medicinal product based on the mutual recognition procedure of registration conducted by the Member
States under No. NL/H/4569/001/P/001, in compliance with Article 61(3) of Directive 2001/83/EC of the
European Parliament and of the Council on the Community code relating to medicinal products for
human use:
Name: ONDANSETRON ÁCCORD
Strength: 2MG/ML
Pharmaceutical form: inj/inf.sol.
Registration number: 20/176/10-C
Issued on: 23.10.2018
Holder of the registration decision:
ACCORD HEALTHCARE POLSKA Sp. z o.o., Taśmowa 7, 02-677 Warsaw, Poland
Represented by:
ACCORD HEALTHCARE LIMITED, Sage House, 319 Pinner Road, HA1 4HF North Harrow -
Middlesex, United Kingdom
The change consists of
1. Alterations in the labeling on the packaging of the medicinal product.
2. Adjustments in the package leaflet information unrelated to the summary of product
characteristics.

Justification
In compliance with Section 68(4) of Act No. 500/2004 Coll., the Administrative Procedure Code, as
amended, no justification is provided as the requests for registration change have been fully satisfied.

F-REG-010-132/1.1.2019 Accord Health Polska Sp. z o.o.

02-677 Warsaw, ul. Taśmowa 7
Tax Identification Number (NIP): 1070015415,
National Official Business Register Number (REGON): 142248997
KRS (National Court Register) Number: 0000347170
Along with this letter, the Institute is also sending:

Package Leaflet for the medicinal product and handling instructions.

Information provided on the packaging of the medicinal product.

Ing. Irena Lukáčová

Head of the Department of Administrative and Procedural Support

F-REG-010-132/1.1.2019 Accord Health Polska Sp. z o.o.

02-677 Warsaw, ul. Taśmowa 7
Tax Identification Number (NIP): 1070015415,
National Official Business Register Number (REGON): 142248997
KRS (National Court Register) Number: 0000347170
Confirmation of conversion of the document into physical paper format by an
official authorized party
I hereby certify, under serial number 117540604-130864-190404120505, that this document in paper
form, which was created by converting from a document contained in a data message consisting of 2
pages, corresponds to the content of the document from which it was converted. The authorized
conversion of the document does not confirm the accuracy and truthfulness of the information contained
in the document or its compliance with legal regulations.

The incoming document contained in the data message was signed by a qualified electronic signature.
The serial number of the qualified certificate 00AF24DA was issued by the accredited certification
services provider I.CA Qualified 2 CA/RSA 02/2016 for the signing person (identifying person)
SN=Lukáčová, G=Irena, State Institute for Drug Control, Ing. Irena Lukáčová, CZ.

The electronic signature was marked with a valid time stamp based on a qualified certificate issued by an
accredited certification services provider. The validity of the time stamp was verified on 4th April 2019 at
11:02:45. Details of the time stamp: date and time: 3rd April 2019 at 9:18:20, serial number of the
qualified time stamp 00AE83B8, qualified time stamp was issued by the accredited certification services
provider "První certifikační autorita, a.s.", I.CA Qualified 2 CA/RSA 02/2016, CZ.

The entity that performed the authorized conversion of the document:

State Institute for Drug Control
Date of preparation of the verification certificate:
04.04.2019
Name, surname, and signature of the person who performed the authorized conversion of the
document:
Eva Šedivá - Department of Administrative Support
Official stamp imprint:

Note:
This verification certificate can be verified through the central registry of verification documents, enabling remote verification at the address
https://www.czechpoint.cz/overovacidokladu.

Accord Health Polska Sp. z o.o.

02-677 Warsaw, ul. Taśmowa 7
 Tax Identification Number (NIP): 1070015415,
National Official Business Register Number (REGON): 142248997
KRS (National Court Register) Number: 0000347170
State Institute for Drug Control
Šrobárova 48
100 41 Prague 10
Czech Republic
(114)
(emblem)

State Institute for Drug Control

Šrobarova 48, 100 41 Prague 10
Tel: +420 272 185 111
Fax: +420 271 732 377
E-mail: posta@sukl.cz
Web: www.sulk.cz

Recipient
Accord Healthcare Limited
Sage House, 319 Pinner Road
HA1 4HF North Harrow
Middlesex
United Kingdom

Delivery address

Ing. Ludmila Nováková

Pod Kesnerkou 39
150 00 Prague 5

Reference Number
Sukls113320/2012
Handled/Department
Dr. rer. Nat. Marcela Rybínová, Ph.D. / 643
Date
3.5.2017

DECISION

DECISION
The State Institute for Drug Control, located in Prague 10, Šrobárova 48 (hereinafter referred to as the
"Institute"), acting as the competent authority in accordance with Section 13(2)(a)(1) of Act No. 378/2007
Coll., on Pharmaceuticals and Amendments to Some Related Acts (referred to as the "Pharmaceuticals
Act"), as amended, in compliance with Section 67 and subsequent provisions of Act No. 500/2004 Coll.,
the Administrative Procedure Code (referred to as the "Administrative Procedure Code"), in proceedings
concerning the extension of the validity of the registration of a medicinal product through the mutual
recognition procedure of registrations by member states (referred to as the "mutual recognition
procedure") conducted pursuant to Section 34 of the Pharmaceuticals Act, regarding the application for
extension of the validity of the registration of a medicinal product submitted on the 7th of May, 2012:

Accord Healthcare Limited, Sage House, Pinner Road 319, HA1 4HF North Harrow, Middlesex,
United Kingdom
represented by: Ing. Ludmila Nováková, Pod Kesnerkou 39, 150 00 Prague 5
(hereinafter referred to as the "Participant in the Proceedings")

Therefore:

1. The Institute, based on the mutual recognition procedure conducted under No.
UK/H/1250/001/R/001, extends the validity period of the registration of the medicinal
product:
Name: ONDANSETRON ACCORD 2MG/ML INJECTION/INFUSION SOLUTION
Strength: 2MG/ML
Pharmaceutical form: Inj/inf.sol.
Registration number: 20/176/10-C

indefinitely.

2. The Institute, in compliance with Section 93e of the Pharmaceuticals Act, places the
following obligations on the participant in the proceedings as the holder of the registration
decision:

 To periodically provide the Institute with updated safety reports regarding the medicinal product,
as stipulated in Section 93e of the Pharmaceuticals Act, adhering to the deadlines established for
such reports in the reference member state.
 F-REG-010-07Z/19.12.2016 Accord Health Polska Sp. z o.o.
02-677 Warsaw, ul. Taśmowa 7
Tax Identification Number (NIP): 1070015415,
National Official Business Register Number (REGON): 142248997
KRS (National Court Register) Number: 0000347170
Justification
Justification is not provided in accordance with Section 68(4) of the Administrative Procedure Code, as
the requests for extension of registration validity have been fully met.

Notification of appeal
A challenge to this decision can be filed with the Institute as per Section 81 and following provisions of
the Administrative Procedure Code within 15 days from the date of its receipt. The Ministry of Health
will adjudicate the appeal.

Imprint of the official stamp

Tomáš Boráň MD
Head of the Clinical Evaluation Division
within the Medicines Registration Department
 F-REG-010-07Z/19.12.2016 Accord Health Polska Sp. z o.o.
02-677 Warsaw, ul. Taśmowa 7
Tax Identification Number (NIP): 1070015415,
National Official Business Register Number (REGON): 142248997
KRS (National Court Register) Number: 0000347170
Confirmation of conversion of the document into physical paper format by an
official authorized party

I certify under the serial number 96402260-130864-170504124S57 that this document in paper form,
which originated from a document contained in the data message, consisting of 2 pages, corresponds to
the content of the document from which it was converted. The authorized conversion of the document
does not confirm the accuracy and truthfulness of the data contained therein and their compliance with
legal regulations.
The incoming document contained in the data message was signed by a qualified electronic signature.
The serial number of the qualified certificate 00AB3AEA was issued by the accredited certification
services provider I.CA Qualified 2 CA/RSA 0212016 for the signing person (designated person)
SN=Boráň, G=Tomáš, State Institute for Drug Control, CZ, MUDr. Tomáš Boráň.
The electronic signature was marked with a valid time stamp, based on a qualified certificate issued by
the accredited provider of certification services.
The validity of the time stamp was verified on 3.5.2017 at 14:57:24. Time stamp data: date and time
3.5.2017 14:57:24, qualified time stamp number 00AB2010, the qualified time stamp was issued by the
accredited provider of certification services "První certifikačni autorita, a.s.", I.CA Qualified 2
CA/RSA 02/2016, CZ.
The entity that performed the authorized conversion of the document:
State Institute for Drug Control
Date of issuance of the verification certificate:
04.05.2017
Name, surname, and signature of the person who performed the authorized conversion of the
document:
Eva Šedivá - Administrative Support Department.
Official stamp imprint:

Note:
This verification certificate can be verified through the central registry of verification documents, enabling remote verification at the address
https://www.czechpoint.cz/overovacidokladu.
 Accord Health Polska Sp. z o.o.
02-677 Warsaw, ul. Taśmowa 7
Tax Identification Number (NIP): 1070015415,
National Official Business Register Number (REGON): 142248997
KRS (National Court Register) Number: 0000347170