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1.Signed on November 20, 2019 and September 23, 2019 Entered into force on December 04, 2019

 
The EU Official Control Authority Batch Release (OCABR) Network
for vaccines for human use and medicinal products derived from
human blood and plasma as represented by the European
Directorate of the Quality of Medicines and HealthCare (EDQM) of
the Council of Europe, is hereinafter referred to as ‘ the
Human OCABR Network ’

The Taiwan Food and Drug Administration is hereinafter referred
to as TFDA.

The TFDA and the Human OCABR Network are hereinafter jointly
referred to as ‘ the Participants ’.

Recognising that the Participants share a common goal to protect
health and safety by assessing the quality of vaccines for human
use and medicinal products derived from human blood and plasma
(Biological Medicinal Products) through physical analysis of
batches of these Biological Medicinal Products.

Recalling that the TFDA is an observer of the European
Pharmacopoeia Commission and officially recognises the European
Pharmacopoeia as a standard and that they are an associate
member of the General European OMCL Network (GEON) and share in
common the principles of the GEON and comply with the GEON
definition of an Official Medicines Control Laboratory (OMCL);

The Participants have reached the following understanding:
I.PURPOSE
1) This Memorandum of Understanding (MOU) establishes an
arrangement between TFDA and the Human OCABR Network for
collaboration and exchange of information related to the
evaluation of batches of Biological Medicinal Products as
conducted by the Human OCABR Network and as conducted by TFDA
during the course of their regulatory activity.
2) This MOU does not modify existing cooperative activities nor
does it preclude entering into separate arrangements for
specific activities that can be handled more efficiently by
special arrangements.
II. A) DEFINITIONS
Biological Medicinal Products: In the context of this
document means vaccines and sera for human use and medicinal
products derived from human blood and plasma which are
subject to OCABR.
Mutually recognised partner: In the context of this document
refers to countries which have signed a formal legal
agreement with the EU which includes batch release activity
e.g a Mutual Recognition Agreement or Agreement on
Conformity Assessment and Acceptance of Industrial Products.
Official Control Authority Batch Release: a codified system
in the EU for control of biological medicinal products batch
by batch before they are placed on the market as defined in
EU Directive 2001/83/EC as amended by 2004/27/EC and
detailed in the current Administrative Procedure for OCABR
in the EU.
Official Medicines Control Laboratory: an independent
laboratory which carries out analytical analysis of
medicinal products which fits the definition of an OMCL in
the current Terms of Reference of the General OMCL Network.
Outside partners: Organisations or countries outside of the
Human OCABR network, its Mutually Recognised partners and/or
MOU partners.
II. B) ABBREVIATIONS
COE: Council of Europe
EDQM: European Directorate of the Quality of Medicines and
HealthCare
EU: European Union
GEON: General European OMCL Network
MOU: Memorandum of Understanding
OCABR: Official Control Authority Batch Release
OMCL: Official Medicines Control Laboratory
III. SCOPE
The following outlines the agreed scope of the exchange.
Part A: Exchange of Information
A.1 The Human OCABR network will:
1) Allow TFDA to participate in the blood, vaccine and common
OCABR sessions of the Human OCABR Network annual meeting.
2) Provide TFDA with timely access to annual reports of OCABR
blood and vaccine activity from the network prior to the
annual meeting in accordance with the EU Administrative
Procedure for OCABR and to all documents distributed to
participants at such a meeting.
3) Provide notice to TFDA of confidential information relating
to the status of a batch of medicinal product derived from
human blood and plasma and vaccines, such as OCABR notice of
non-compliance or withdrawal from parallel testing, when it
arises, using the information exchange tools in the EU
Administrative Procedure for OCABR (e.g. Annexes IIe, VI, VII
and VIII). As a result it will include TFDA as an observer in
Annex III blood/vaccine contacts of the EU Administrative
Procedure for OCABR.
4) Provide TFDA with access to internal procedures and documents
of the Human OCABR network.
A.2 TFDA will:
1. Agree, in attending the annual meeting of OCABR blood,
vaccine and common sessions, to limit its involvement to
comment on the meeting documents or material provided to all
participants; that it will not have any decision-making
capacity nor right to vote respecting the adoption of
documents or other forms of information provided for that
purpose; and that it will not have the right to vote in
elections for members of the Advisory Group.
2. Provide, in advance of the annual meeting of the Human OCABR
network, a report on its activity concerning medicinal
products derived from human blood and plasma and vaccines
similar to the OCABR activity including technical details on
batches tested using the annual report format (Annex V of the
EU Administrative Procedure for OCABR) as far as possible.
3. Provide notice to the Human OCABR network of confidential
information regarding the status of batches of medicinal
products derived from human blood or plasma and vaccines,
when there are concerns related to quality, as the
information becomes available. If appropriate, the
information exchange tools in the EU Administrative Procedure
for OCABR (e.g. Annexes VI and VII) should be used.
4. Provide the Human OCABR network with access to internal
procedures and documents of their batch release related
activity as needed.
Part B: Use of Information
1) The information shared or exchanged will only be used for the
purposes of this MOU and in the context of batch control
activity for the OMCLs/National regulatory authority(ies) and
related activity concerning license assessment and inspection
activity by the control authorities.
2) Information exchanged under this MOU may contain confidential
information exempt from public disclosure under the laws and
regulations of Taiwan (R.O.C) and the Council of
Europe/European Union Member States. Information that is
exempt from public disclosure will only be shared according
to the procedures and policies of the Participants as
permitted by their respective laws and regulations. Neither
TFDA nor the Human OCABR Network will divulge confidential
information including but not limited to trade secret
information and personal information to outside partners
without the consent of the provider of such information.
IV. ROLES
1) The Participants acknowledge that the administration of this
MOU, including management of issues arising from the
application of the MOU and the evaluation and communication
of the application of the MOU, will rest with the
administrator of each Participant. Administrators will be:
a) For the Human OCABR Network, the person holding the
position of Director EDQM; and
b) For TFDA, the person holding the position of Director
General
2) The Participants acknowledge that written requests for
information and documentation should be made to the
identified contact person for each Participant. The contact
person will carry out the day-to-day operations and monitor
the application of the MOU. The contact person will be:
a) For the Human OCABR Network, the person holding the
position of Head of the Department for Biological
Standardisation, OMCL Network and HealthCare or the Deputy
Head; and
b) For TFDA, the person holding the position of section chief
3) The Participants acknowledge that they will establish a
mechanism for communication on an annual or as needed basis
as a means of facilitating the application and functioning of
this MOU.
4) The Participants acknowledge that they will notify each other
of changes in their respective legislation, regulations,
operational practices, policies and procedures relating to
matters covered by this MOU which might impact on their
ability to cooperate as intended by this MOU.
5) The Participants acknowledge that if any information or
documentation is provided to the other, it will be free of
charge.
V. COMMENCEMENT, REVIEW, AMENDMENT AND TERMINATION
1) This MOU will come into effect 10 working days after it is
signed by the last Participant.
2) The MOU will be reviewed yearly by the OCABR Advisory Group
on the occasion of the first OCABR Advisory group meeting
after the annual meeting of a given year.
3) The MOU may be amended at any time with the written consent
of the Participants. Any such amendment will come into effect
on the date determined by the Participants.
4) Either Participant may terminate this MOU by written notice
to the other Participant. The MOU will then terminate 30
calendar days after receipt of the notice to terminate.

Signed in duplicate on 23/09/19 in Strasbourg, France(initials)

Signed in duplicate on 20/11/19 in Taipei, Taiwan(initials)


___________________ ___________________
Dr. Shou-Mei Wu Dr. Susanne Keitel

Director General Director
Taiwan Food and Drug The European
Administration Directorate for the
Quality of Medicines
and HealthCare of the
Council of Europe for
the Human OCABR
Network
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