I SS UE NO 1 8 May – August 2004
MEDICINAL PRODUCTS
MAY – AUGUST 2 01 0 Issue No. 36
IRISH MEDICINES BOARD, KEVIN O’MALLEY HOUSE, EARLSFORT CENTRE, EARLSFORT TERRACE, DUBLIN 2 TEL: 01 676 4971 FAX: 01 6767836 EMAIL: FOI@IMB.IE
GENERAL
CONTENTS
S IGN ING O F MEMORANDUM 2010 by Dr. Rohan Hammett, National
O F U NDERS TAN DING BETW EEN Manager of the TGA, and Mr. Pat General
O’Mahony, Chief Executive of the IMB. • Signing of Memorandum of
THE THERAP EUTIC GOO DS
The purpose of the memorandum is Understanding between The
ADMINIS TRATIO N OF to promote an understanding of both Therapeutic Goods Administration
AU S TRAL IA AN D THE IMB parties’ framework, requirements and of Australia and the IMB 1
processes, to facilitate the exchange of • Herbal medicines on the Irish Market
2010 1
W ith the view of establishing a
framework for cooperation in the
area of the regulation of therapeutic
information and documentation, to
encourage collaborative activities and
to enhance the parties’ ability to
• Authorisation or registration
numbering system 2
goods, a Memorandum of Understand- provide efficient services relating to or
ing between the Therapeutic Goods in connection with public health while Human Medicines
Administration (TGA) of Australia and meeting the needs of their respective • Project to update the legal status of
the IMB was signed in Dublin on 8 June population. centrally authorised medicinal
products 2
• Change in the procedure for
requesting Ireland to act as Reference
Member State (RMS) in a
Decentralised Procedure for a Human
Medicinal Product 3
Veterinary Medicines
• Collection of data on veterinary
consumption of antimicrobials 3
• Update on status of flukicides
without MRL for milk 3
• Staff changes 3
Compliance
• Requirements for QP declarations for
inclusion of third-country contract
manufacturers / testing facilities for
IMP authorisation 3
• Meeting of the PIC/S Expert Circle
on active substances 4
• Persistent Organic Pollutants
Regulations 2010, S.I. No. 235 of
2010 (‘POPs Regulations’) 4
• Reporting of quality defects 5
Mr. Pat O’Mahony, Chief Executive of the IMB and Dr. Rohan Hammett, National Manager of the TGA, Dublin, • Micronisation of active substances 5
8 June 2010 • Controlled Drugs – Update to Misuse
of Drugs Regulations 2010 5
• Use of small volume cold chain
HERB AL MEDIC INES ON THE which were on the market at that time insulated shippers 5
IRIS H MARK ET 20 10 can remain on the market provided an • Cosmetics update 6
application is made for registration • Joint inspections with the US FDA
(notice reprinted from EMA website)
U nder the provisions of the Medici-
nal Products (Control of Placing on
the Market) Regulations 2007, S.I. 540
under the Traditional Herbal Medicinal
Products (THMP) registration scheme
and registration is issued by the Irish
• GMP and market compliance
information day
6
6
of 2007, as amended, no new herbal Medicines Board by 30 April 2011.
medicinal product can be placed on the After this time, a herbal medicinal
market after July 2007 without the product may not remain on the Irish
prior approval of the IMB. Products market legally without a marketing §
I S SUE NO 3 6 May – August 2010 PAGE 2
authorisation or THMP registration. Products containing such herbs AUTHORIS ATION OR
Further details of the authorisation and take the form of tablets, capsules, REGISTRATION NUMB ERIN G
traditional registration schemes for other solid and liquid dosage forms
SYSTEM
herbal medicinal products may be and the dried herbs themselves or
found on the IMB’s website. teas made from these herbs. However,
As of mid-2010, the number of ap-
plications for the THMP registration
where concentrated extracts or tinc-
tures are used or other parts of the
T he IMB has received queries about
the format of the numbering system
on the licence and on the IMB website.
scheme has been disappointingly plant, safety for use in food cannot For PA, PPA, DPR, HNR, HOR, and TR
small in comparison with the num- necessarily be guaranteed and poten- numbers, the number displayed on the
ber of products actually on the mar- tial users are recommended to con- website takes the format e.g.
ket. In order to facilitate the sult the IMB on individual cases. PA0123/004/005, consisting of three
registration process and give greater In regard to the above, it should distinct sections of 4 digits, 3 digits and
clarity to companies, some of which be understood that in order for 3 digits respectively. This format is due
are continuing to place herbal me- herbal substances to be included in a to the numbering generated automati-
dicinal products on the market inap- food supplement, no medicinal cally from our IT systems. When
propriately as food supplements, the claim can be made for the product putting the number on packaging
IMB has proposed to publish two lists on its packaging or associated litera- materials there is no requirement to
of herbal substances. ture. These two lists should not be include the preceding zeros, i.e. PA
The first list is a list of herbal sub- considered exhaustive and will be 123/4/5 may be used.
stances which are not considered to be added to or deleted from as experi-
suitable for inclusion in food supple- ence is gained. Any queries on the
ments. These herbal substances are con- contents or the usage of these lists or
sidered to be potentially toxic or have any comments should be addressed
potent pharmacological action which to herbalmedicines@imb.ie. The two
makes them medicinal substances draft lists can be accessed on the
under the definition given in Article 1 IMB’s website.
of Directive 2001/83/EC as amended.
HUMAN MEDICINES
P RO J ECT TO U PDATE THE ‘Guideline on Legal Status for the the restrictions outlined in Regula-
L EGAL S TATU S O F CENTRAL LY Supply of Centrally Authorised Prod- tion 7 of the Medicinal Products (Pre-
ucts’, the sub-categories of non-re- scription and Control of Supply)
AU THO RIS ED MEDICINAL
newable (S1A) and renewable (S1B) Regulations. In general, if a substance
P RO DU CTS may be used at a national level in is listed in Schedule 1 of these Regu-
Member States. The guideline may be lations as renewable (S1B), the classi-
T he IMB is currently undertaking a
project to update the legal status
(method of sale, supply and promo-
found on the EMA website.
In order to comply with the legis-
fication of a centrally-authorised
product containing that substance
lation and EMA guidance, centrally- will not be changed unless it has
tion) for centrally-authorised medicinal authorised products are designated as been deemed ‘restricted’ and/or ‘spe-
products (authorisation granted by the S1A or S1B, with S1A having more re- cial’ by the EMA, whereby the status
European Commission under Regula- strictions with regard to dispensing. of that particular product will change
tion (EEC) 2309/93 or Regulation (EC) In general, all parenterals (excluding to non-renewable (S1A). Each prod-
No. 726/2004). This information is insulin) are classified as S1A. For uct will be considered on an individ-
published on our website. products subject to medical prescrip- ual basis.
The classification of the method tion, where the EMA has assigned ad- The IMB is updating its website to
of sale, supply and promotion of cen- ditional sub-categories of ‘restricted’ include the legal status of centrally-
trally-authorised medicinal products and/or ‘special’ these are generally authorised products. Marketing
is determined by the Committee for classified by the IMB as S1A. A pre- authorisation holders of centrally-au-
Medicinal Products for Human Use scription for a product that is non-re- thorised products are currently receiv-
(CHMP) and annexed to the Opinion newable (S1A) may be dispensed on ing notification of the legal status of
at the time of the marketing authori- more than one occasion subject to their products and are encouraged to
sation. Currently all centrally-autho- review them and revert if they wish to
rised products default to S1B seek clarification.
according to Regulation 7(10) (b) of Any queries regarding this project
the Medicinal Products (Prescription should be submitted (by email) to
and Control of Supply) Regulations customerservice@imb.ie clearly mark-
(S.I. No. 540 of 2003) as amended. ed as ‘Method of Sale, Supply & Pro-
However, according to the EMA motion project’.
I S SUE NO 3 6 May – August 2010 PAGE 3
CHANGE IN THE PROCEDURE FOR for the IMB to act as RMS for human
REQUESTING IRELAND TO ACT AS medicinal products. The window for
requests will open at certain periods
REFERENCE MEMBER STATE (RMS)
during the year and all requests
IN A DECENTRALISED PROCEDURE received will be considered. Successful
FOR A HUMAN MEDICINAL requests will be allocated a dedicated
PRODUCT slot for assessment of their application.
Guidance will be published on our
T he IMB would like to inform appli-
cants of its plan to introduce a new
‘window’ system for managing requests
website shortly and the first window
for requests is due to open in Septem-
ber 2010.
VETERINARY MEDICINES
C O LLEC TIO N O F DATA ON UP DATE ON STATUS OF wholesaler after 31 July 2010. Prod-
V ETERINARY C O NSUMPTION OF FLUK ICIDES WITHOUT MRL ucts with literature which have not
been changed are liable to be seized
AN TIMICROBIALS FOR MIL K
by the Department of Agriculture,
Fisheries and Food from that date.
T he Veterinary Medicines Department
has begun the task of requesting
marketing authorisation holders
S takeholders will be aware of the
action taken by the IMB in February
to update the Summary of Product
The IMB has separately initiated
Article 9 procedures under Regulation
(MAHs) to complete the template as Characteristics of flukicidal products 470 EC 2009 requesting the European
required under the European Surveil- for cattle which did not have a Medicines Agency (EMA) to establish
lance of Veterinary Antimicrobial maximum residue limit (MRL) estab- MRLs for milk for the substances in-
Consumption (ESVAC) project. The IMB lished in milk. This action was to clarify volved. This is the first time this par-
has populated a number of the required that the products in question were not ticular procedure has been used. At the
fields in the template with data from its permitted for use in animals producing end of June, the EMA confirmed their
own database and has forwarded the milk for human consumption, includ- acceptance of the eligibility of the sub-
template to MAHs for their input. The ing pregnant animals intended to stances closantel, nitroxynil, rafox-
completed information should be produce milk for human consumption. anide and triclabendazole for this
returned to the IMB before 24 Septem- All involved marketing authorisa- procedure which is now underway.
ber 2010, preferably by electronic tion holders submitted the required
STAFF CHANGES
means (michelle.sinnott@imb.ie). The variation applications to amend the
necessary data, once received by the
IMB, will be sent to the European
Medicines Agency (EMA) for aggrega-
product literature thus facilitating the
IMB’s response to the situation. Prod-
uct in old livery should not be re-
M s. Katarina Dankova left the
Veterinary Medicines Department
on 19 August. The IMB wishes her well
tion with those of other Member States. leased from the manufacturer or in her new career.
COMPLIANCE
REQ U IREMEN T FOR QP circumstances that can arise and are re- agreement is relevant to the product
DECL ARATIO NS FO R ferred to below... in question. In the absence of an
b) Product imported directly from a 3rd MRA, the Qualified Person should
INCLUSION OF THIRD-COUNTRY
country: the duties are laid down in determine that equivalent standards
C O N TRAC T MAN UFACTURERS / article 13.3(b) of Directive of Good Manufacturing Practice
TES TIN G FAC IL ITIES FO R IMP 2001/20/EC. Where investigational apply through knowledge of the qual-
AU THO RIS ATIO N medicinal products are imported ity system employed at the manufac-
from a 3rd country and they are sub- turer. This knowledge is normally
U nder EU GMPs
paragraph 39,
Annex 13, ject to arrangements concluded be-
tween the Community and that
country, such as a Mutual Recogni-
acquired through participation in
audit of the manufacturer’s quality
systems. In either case, the Qualified
The duties of the Qualified Person in re- tion Agreement (MRA), equivalent Person may then certify on the basis
lation to investigational medicinal prod- standards of Good Manufacturing of documentation supplied by the 3rd
ucts are affected by the different Practice apply provided any such country manufacturer. §
I S SUE NO 3 6 May – August 2010 PAGE 4
In cases where an authorised IMP No 850/2004 on persistent organic
manufacturer is intending to submit a pollutants,1 as amended (‘Regulation
variation to include a third-country 850/2004’). The objective of Regulation
contract manufacturing site or contract 850/2004 is to protect human health
testing site and where no MRA exists and the environment from POPs by
with this third country, such variation prohibiting, phasing out, or restricting
applications should include a declara- the production, placing on the market
tion that the QP is satisfied that the site and use of specified POPs. It is intended
operates in accordance with a standard that this will be achieved by minimis-
equivalent to EU GMP at the time of ing, with a view to eliminating where
submission of the application. feasible, releases of such substances,
This determination by the QP and by establishing provisions regard-
should be based upon knowledge of the ing waste consisting of, containing or
quality system employed at the contaminated by any of these
manufacturer. This knowledge is substances.
normally acquired through participa- The Environmental Protection
days of the meeting were held at the
tion in an audit of the manufacturer’s Agency (EPA) is the competent author-
Institute of Technology, Tallaght, and
premises and quality system. ity for the purposes of the POPs Regula-
the IMB is particularly appreciative of
The QP making the declaration tions. The IMB is specified in the POPs
the Institute’s assistance which, in
should have sufficient knowledge of Regulations as the ‘public authority
addition to the conference facilities,
the processes concerned and documen- concerned’ for ‘persistent organic pollu-
included a tour of the Institute’s pilot
tary evidence should be available to tants used or intended for use in medicinal
scale manufacturing unit and laborato-
support this. It is on the understanding or veterinary applications’.2 As such, the
ries.
that the declaration accompanying IMB is required to have regard to the
The feedback from the meeting
such applications affirms that the site requirements of the POPs Regulations
delegates was, in general, favourable.
operates in compliance with EU GMP and Regulation 850/2004 in the
Tangible outputs from the meeting
that such variations are approved and exercise of its powers, functions and
included a series of questions and
the site is named on the IMP manufac- duties. The IMB is required to co-
answers on the distribution of APIs
turer’s authorisation. The IMP authori- operate with the EPA. Provision is made
which will be proposed for publication
sation holder should have a procedure for the EPA to enter into arrangements
on the PIC/S website. In addition, the
in place describing the requirements with the IMB regarding the implemen-
draft quality risk management tool
for submission of such a declaration. tation of and compliance with the
developed by the PIC/S expert circle on
The IMB reserves the right to POPs Regulations and Regulation
Quality Risk Management (QRM) was
inspect any such third-country sites 850/2004. These may include obliga-
evaluated for application to the inspec-
and also to request copies of audit tions on the provision of awareness
tion of existing API sites and new API
reports to support such variation appli- programmes, public information and
sites. The feedback and conclusions
cations. training, as well as monitoring and
from this discussion will be outlined to
reporting. The IMB may bring
the QRM Expert Circle.
MEETIN G O F THE P IC/ S EXP ERT summary proceedings for an offence
under the POPs Regulations.
C IRC L E O N AC TIVE PERSISTENT ORGANIC Many of the substances described in
S UB S TANCES P OLL UTANTS REGUL ATIO NS Regulation 850/2004, Annex I, Part A
are pesticides. There are restrictions
T he Third Meeting of the PIC/S
Expert Circle on Active Pharmaceu-
tical Ingredients was hosted by the IMB
201 0, S.I. NO. 23 5 OF 20 10
(‘P OP S REGU LATIONS’)
within the EU Guide to GMP regarding
the processing of pesticides in facilities
used for the manufacture of active
in Dublin on 26 – 28 May. This Expert
Circle is focused on training of inspec-
tors and development of guidance for
T here is worldwide concern at the
continuing release of persistent
organic pollutants (POPs) into the
pharmaceutical ingredients or medici-
nal products.
inspection of APIs. Sixty-nine partici- environment. These chemical Subject to any arrangement with
pants from 27 national agencies for substances are transported across inter- the EPA, IMB inspections may in future
medicines or international organisa- national boundaries far from their include monitoring for POPs during
tions attended the meeting. sources and they persist in the environ- routine inspections of those sites where
The main subjects of the meeting ment, bio-accumulate through the chemicals that are classified as POPs
were supply chain management and food web, and pose a risk to human may be used for processing or for non-
quality risk management for inspection health and the environment. The aim process applications. It is envisaged
planning. The format of the meeting of the POPs Regulations (effective from that any such activity will be incorpo-
consisted of a small number of presen- 31 May 2010) is to give effect to rated into existing voluntary and
tations and workshops. The first two relevant provisions of Regulation (EC) mandatory inspections.
1 Regulation (EC) No 850/2004 of the European Parliament and of the Council of 29 April 2004 on persistent organic pollutants and amending Directive
79/117/EEC
2 Persistant Organic Pollutants Regulations, Art 7(1)(b)
I S SUE NO 3 6 May - August 2010 PAGE 5
REP O RTIN G O F QUALITY micronisation process (and site where the Misuse of Drugs Regulations into
DEF EC TS the activity takes place, if different) is which these have been placed, are set
considered to fall within the scope of out within the following statutory
In 2009, the IMB investigated 614
reports of quality defects, of which 98
resulted in recall action on the Irish
the GMP declaration for the active
substance supplied by the Qualified
instruments:
• Misuse of Drugs Act 1977
Person in support of the marketing
market. A total of 164 were classified as • (Controlled Drugs) (Declaration)
authorisation application.
minor and posing minimal risk to • Order 2010 (S.I. No. 199 of 2010)
Where micronisation is arranged by
patient safety. Following review of the • Misuse of Drugs (Amendment)
the medicinal product manufacturer,
regulatory oversight requirement, the • Regulations 2010 (S.I. No. 200 of
the site performing micronisation
IMB will shortly publish guidance on 2010)
should be named as a contract
the occasions when it will not be neces- manufacturer on the manufac- This new legislation is of interest to
sary for some of these minor defects to turer’s/importer’s authorisation (MIA) medicinal product manufacturers and
be reported to the IMB. This guidance held by the medicinal product wholesalers as it introduces control
note is intended to help stakeholders to manufacturer. This would be a techni- under Misuse of Drugs Acts for the
identify the quality defects that should cal variation to the MIA and should be following active pharmaceutical ingre-
be reported. These stakeholders include supported by documentary evidence dients: remifentanil, zolpidem and
marketing authorisation holders, that the micronisation site has under- ketamine. The IMB has already
manufacturers and wholesalers. gone a successful GMP inspection by communicated with the relevant
The document will cover: an EU authority in relation to this sectors of those industries directly
• Guidance on how to classify quality activity. impacted by the changes. However, it
defects; is important that, within the wider
• Criteria to use to determine if a industry, those manufacturers and
quality defect is reportable or not; wholesalers which may have future
• The IMB’s expectations of stake- business interest involving these
holders when a quality defect is not substances are also kept informed of
reported to the IMB; the new controls now applicable to
• Examples of quality defects which these substances, and can consider, in
should be reported to the IMB; advance, the impact of these changes
• How to report quality defects to the on their proposed activities.
IMB. If you require any further clarifica-
tion or information regarding the legis-
The document will be published in late lation update, please do not hesitate to
September and will be available on the contact deirdre.ryan@imb.ie.
IMB website. CONTROL LED DRUGS
The guidance note will be covered – UP DATE TO MISUSE OF USE OF SMALL VOLUME C OL D
at the GMP and Market Compliance
Information Day on 14 October 2010, DRUGS REGU LATIO NS 20 10 CHAIN INSULATED SHIP P ERS
under the agenda topic ‘New IMB
Guidance Note – How to Determine if a
Quality Defect Should be Reported to the
N ew legislation to control a range of
drugs and substances was intro-
duced under the Misuse of Drugs Acts
D uring recent wholesale inspections,
a number of deficiencies have been
cited relating to the use of insulated
IMB’. on 11 May 2010. A primary focus of shippers to transport small volumes of
this legislation was to place control on product requiring 2-8°C storage and, in
MIC RO N IS ATIO N OF ACTIV E certain synthetic cannabinoids, BZP particular, the validation of these
derivatives, mephedrone and related shippers.
S UB S TANCES Wholesalers are reminded that all
cathinones, so called ’legal highs’
which were being supplied in ‘head deliveries using cold chain shippers
M icronisation of active substances
may be carried out by an active
substance manufacturer before supply
shops’ in Ireland.
However, the legislation has also
should be completed within the time
period for which the shippers were
of a material to an authorised medici- controlled a number of other drugs and validated. To ensure this, the time of
nal product manufacturer or, alterna- substances (see below) including some packing should be included on delivery
tively, arrangements may be made by used in medicines, under the Misuse of documentation along with the
the medicinal product manufacturer to Drugs Acts. These were already maximum validated time for the
have the material micronised. In all controlled under the UN Conventions shippers.
cases, micronisation of an active on Narcotic Drugs and Psychotropic Should any material changes be
substance should be an activity which Substances. The new legislation has made to the validated shipper (e.g.
is covered within the marketing autho- brought Ireland’s control measures in change in box, type or size of
risation dossier for the product. line with existing international chill/frozen packs, change in assem-
Where the active substance is controls. bly/configuration etc), the transporta-
Should the wholesaler believe that §
supplied in micronised form by the The drugs and substances now tion system should be revalidated.
active substance manufacturer, the covered, including the Schedules under
I S SUE NO 3 6 May – August 2010 PAGE 6
a revalidation is not required, America (US FDA – see website)
documented justification should be continue to seek potential candidate
available to an IMB inspector. In this companies for a joint GMP inspection
regard wholesalers should also take into pilot programme for manufacturers of
account the impact of use and ’wear- medicinal products. Companies that
and-tear’ on the continued validated have submitted in parallel two equiva-
status of the delivery system. This lent marketing authorisation applica-
should also include periodic assessment tions for the same medicinal product to
of the need to replace the system or both the EMA and the US FDA can
component parts. tion day are available on our website, request to participate in the pilot
Wholesalers should note that the as well as additional guidance on notifi- programme for joint pre-approval
temperature at which a chill/frozen cation requirements, complying with inspection should such an inspection
pack is chilled/frozen will significantly the legislation and how to apply for be considered necessary by both
impact on the temperature within the certificates of free sale. agencies.
shipper. Therefore, it should be ensured Once the legislation is in place, the The overall objective is to see
that the temperature within the refrig- IMB will carry out the functions of the whether greater international collabo-
erator/freezer is the same as when the Competent Authority for cosmetics, ration can help to distribute inspection
shipper was originally validated. The including: capacity allowing more manufacturing
duration for which chill/ice packs • the maintenance of a notification sites to be monitored and reducing
should be refrigerated/frozen should database of cosmetic product unnecessary duplication.
also be defined and validated. Refriger- manufacturers and importers; Companies can also participate in
ators/freezers used for this purpose • establishment of a market surveil- the pilot exercise by hosting a single
should be validated and the tempera- lance system involving market joint re-inspection (routine surveil-
ture of these routinely monitored. sampling and analysis and review of lance) where both the EMA and the US
Information is available from the product information files; FDA have separately planned routine
guidance document ‘Guide to Control • enforcement of the legislation, surveillance inspections (re-inspec-
and Monitoring of Storage and Trans- together with our partners in the tions) to take place within a similar
portation Temperature Conditions for HSE; time period at a manufacturing site of a
Medicinal Products and Active • generation of certificates of free sale; medicinal product authorised in the
Substances’, available on the IMB’s and participation in international USA and centrally authorised in the
website. activities, including relevant EU European Union.
working groups. Companies that wish to partici-
C O S METIC S UPDATE The cosmetics function has been pate should contact either
CDERInternationalGMP@fda.hhs.gov.
integrated into the Healthcare Products gmp@ema.europa.eu and/or
I t is intended that legislation to trans-
fer the Competent Authority role for
cosmetics to the IMB from the Depart-
Distribution Section within the
Compliance Department. For specific
queries relating to manufacturing or
ment of Health and Children is placing cosmetic products on the GMP AND MARK ET
planned to come into effect in quarter market, please contact the Compliance COMP LIANCE INFORMATIO N
four 2010. Department at compliance@imb.ie. DAY
On 15 September, the IMB hosted
an information day, with the participa-
tion of key stakeholders involved in
JOIN T INSPECTIONS WITH THE
US FDA (NOTICE REPRINTED
T his Information Day will take place
on 14 October 2010 in the Crown
Plaza Hotel in Santry. Further informa-
cosmetics control, in order to provide
an overview of the transfer of the FROM EMA WEBSITE) tion on the agenda and on how to
Competent Authority role for cosmet- register for this event are available on
ics as well as some practical aspects of ‘11/08/2010 - The European Medicines the IMB website. Please note that the
compliance with the legislation. Agency (EMA) and the Food and Drug closing date for registration is
All presentations from the informa- Administration of the United States of 30 September 2010.
The IMB no longer publishes product statistics in this newsletter. The status of authorisations are updated regularly on our
website, please use the link below for the most up to date details.
http://www.imb.ie/EN/Medicines/HumanMedicines/HumanMedicinesListing.aspx
http://www.imb.ie/EN/Medicines/VeterinaryMedicines/VeterinaryMedicinesListing.aspx
This Bulletin is designed by Ashfield Press Publishing Services for
IRISH MEDICINES BOARD , KEVIN O ’ MALLEY HOUSE , EARLSFORT CENTRE , EARLSFORT TERRACE , DUBLIN 2
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