European Medicines Agency

Human Medicines Evaluation Unit

7 Westferry Circus, Canary Wharf, London, E14 4HB, UK
Tel. (44-20) 74 18 84 00 Fax (44-20)
E-mail: mail@emea.europa.eu http://www.emea.europa.eu
EMEA 2008 Reproduction and/or distribution of this document is authorised for non commercial purposes only provided the EMEA is acknowledged



London, 21 January 2008
Doc. Ref. EMEA/CHMP/25296/2008




OVERVIEW OF COMMENTS RECEIVED ON
DRAFT GUIDELINE ON THE ACCEPTABILITY OF NAMES FOR HUMAN PRODUCTS
PROCESSED THROUGH THE CENTRALISED PROCEDURE




Table 1: Organisations that commented on the draft Guideline as released for consultation

Add name followed by link to individual received comment (upon publication by Web Services)

Name of Organisation or individual Country
1 EFPIA (European Federation of Pharmaceutical Industries and Associations Belgium
2 AESPG (The Association of the European Self-Medication Industry) Belgium
3 EGA (European Generic medicines Association) Belgium
4 INTA (International Trademark Association) Worldwide
5 INSMPC (International Network of Safe Medicines Practice Centres) Worldwide
6 Prescrire France
7 EAEPC (European Association of Euro-Pharmaceutical Companies) Belgium
8 Novartis Switzerland
9 Roche Switzerland
10 SP Corp Belgium


Table 2: DISCUSSION OF COMMENTS

GENERAL COMMENTS - OVERVIEW
EFPIA:
As EFPIA, we welcome Revision 5 of the Guideline and the decision trees which aim to provide clear guidance to Regulators and companies on the acceptability of
invented names for new medicinal products and to increase the transparency of the review procedure, as was discussed at the joint Meetings of 11 September 2006.
The EU enlargement in May 2004 has resulted in increased difficulties in securing a single trade mark that is valid across the EU Member States. As feared, there
has been a drastic increase in the rejection rate in 2006 (up to 68%), although the rate recorded in the first quarter of 2007 is encouraging (50%). For this reason,
industry welcomes clear criteria for the review of proposed invented names to achieve a harmonized standard. We are grateful for the opportunity given to us to
comment. Our members had hoped, however, that the revised version would offer more novelty. Many of the new items represent common practice and therefore
the revision is not really seen as a major improvement compared with the previous version.
There is still a need for greater transparency of the process by which an invented name is checked by the NRG. Similarly, more detail of the objections themselves
plus feedback on company reports submitted to justify an invented name application are called for.
Moreover, our members regret that no reference is made to our proposal to submit minor variations with a view to solving difficulties with the single trade mark
issue in a simple way. We reiterate our proposal for increased flexibility through minor variations, the full details of which are set out in our letter to the
Commission of 6th November 2006. Improvements such as these would be of mutual interest and would in our opinion help to reduce the currently high number of
rejections.


EMEA 2008 Page 2/33

AESPG:
AESGP regards the draft Revision 5 of the Guideline on the acceptability of names for human medicinal products processed through the centralised
procedure as a step in the right direction. Important clarifications have been included to address the particularities of non-prescription medicines.

In light of previous debates and taking into account the current legal framework and its interpretation by the competent European bodies, AESGP would like to
make only a few remarks. While we still hope that, in the longer run, a more liberal system for invented names can be put in place, we feel that, at this point in time,
it does not make sense to re-open more fundamental issues and concerns. We would rather focus on more specific points to get the wording right and to allow the
adoption of Revision 5 within a reasonable timeframe. This is widely seen within the AESGP membership as an important element in deciding whether or not to use
of the centralised procedure for innovative non-prescription medicines.

Unrelated to the specific wording of the guideline, AESGP would like to suggest starting discussion of the following issues in the near future, which might
contribute towards a better functioning of the system in general:

1. Clear mandate for the NRG
In light of the fundamental importance of the NRG for product planning in many companies, it might be appropriate to define the mandate of the NRG in
clearer terms. This should take into account the public health and industrial policy perspectives related to the NRGs work.

2. In light of the above, it might also be useful to discuss the procedure for nominating the NRG membership with the objective of ensuring that the NRG
members are fully aware of their important role from a public health and industrial policy perspective and that they are well qualified to fulfil this role. It
might also be worthwhile considering having the NRG member nominated by the Head of the competent national authority so that his/her work gets appropriate
recognition and is in line with the strategic considerations of the Heads of Medicines Agencies.
For non-prescription medicines, pack design is not only important for the product presentation but also to differentiate between products. In order to contribute to
the objective of avoiding confusion between products, it might therefore be helpful to recognise the role of creative pack design.


EMEA 2008 Page 3/33

Prescrire:
Prescrire is an independent drug bulletin for healthcare professionals. It is totally funded by subscribers and published by Association Mieux Prescrire, a not-for
profit organisation dedicated to improving healthcare and serving patients interest.
Many medication errors are related to confusing trademarks in Europe, with citizens being exposed to preventable adverse effects, sometimes serious.
The risks related to drug trademarks are not acceptable because they are in many ways preventable: the use of drug trademarks is not mandatory; international non-
proprietary names (INN) should be systematically used as usual names and highlighted at all stages of drug treatment, on package leaflets, and both on inner and
outer product packaging (a concern not enough taken into account in the Draft Guideline on the readability of the label and package leaflet of medicinal products
for human use).
As the public body in charge of marketing authorisations through the centralised procedure, the EMEA is fully accountable for the safety of drug trademarks.
Therefore, the Guideline on the acceptability of names for human medicinal products processed through the centralised procedure must guarantee that the public is
not exposed to a risk of medication errors related to invented drug names.
Prescrire welcomes several improvement to the previous guideline (Revision 4), particularly the broadening of criteria assessing safety of proposed trademarks
( no.2.1.1), and encourages the EMEA to draw on experience from independent medication error reporting programmes for reinforcing pharmacovigilance
( no.4.2.6.2). Prescrire also calls on the EMEA:
- to respect its obligations regarding transparency ( no.5);
- to withdraw the new provisions concerning umbrella trademarks for non-prescription medicinal products ( no.2.4.4) , and concerning the rejection of proposed
names by the Name Review Group, even if exceptionally, ( no.4.2.5/4);
- not to change the current Guideline (Revision 4) regarding abbreviations and suffixes ( no.2.3.1), and names of fixed combination products ( no.2.3.5).


EMEA 2008 Page 4/33

INSMPC:
Committed to prevent medication errors and to contribute to safer care, the International Network of Safe Medication Practice Centres (INSMPC) aims to achieve
the essential objectives stated in the Salamanca Declaration to promote safe medication practices globally, to encourage and further the development of safe
medication practice centres in all countries and to facilitate cooperation amongst them: http://www.intmedsafe.net/SalamancaDeclarationINSMPC.pdf
The prevention of medication errors related to similar medicines names requires both pre- and post-marketing strategies and involves drug regulatory agencies,
pharmaceutical manufacturers, medication error reporting programmes, health care practitioners and patients. Pre-marketing strategies should aim at designing new
drug names, which do not pose a risk for confusion with existing names and assess new names in a systematic and standardised approach for a potential to be
confused with existing names. By this, medicines with a high risk of name confusion would not be placed on the market. Post-marketing strategies should aim at
minimising errors occurring with medicines that are already on the market and comprise the implementation of specific practices that prevent errors due to name
confusion and reporting and dissemination of experiences the aim of changing practices and thus reducing the risks of recurrence. Therefore the improvement of the
EMEAs Guideline on the acceptability of names for human medicinal products processed through the centralised procedure towards more patient safety is
welcomed by the INSMPC.
The International Network of Safe Medication Practice Centres considers that it is important to:
- update medicines regulations to require manufacturers to assess the risks of possible sound- or look-alike confusion between the new proposed proprietary names
and existing medicines. This evaluation should be carried out by a standardised procedure, which should include user testing of prescription in oral and written
communication, and an assessment by an expert panel using techniques based on failure mode and effect analysis.
- ensure that when medication errors are reported to the manufacturers and regulatory authorities, there is open disclosure, discussion and feedback regarding
previous similar incidents and error analysis to identify contributory factors, root causes, and an action plan to prevent a recurrence.
- promote sharing of medication error data handled by the medication error reporting systems in Europe with post-marketing monitoring centers, and establish a way
or mechanism through which to channel this information to the EMEA.
On the basis of these principles, the International Network of Safe Medication Practice Centres provides following comments on the Revision 5 of the EMEA
Guideline CPMP/328/98: (see relevant sections)
Roche
We refer to the comments made by EFPIA on April 20, 2007. We support these comments, particularly in view of what is said with regard to
(1) qualifiers not being used as part of the name of the medicinal product (guideline 2.3.1.),
(2) a list of acceptable qualifiers as annex to the guideline (2.3.1.),
(3) use of whole invented names as part of fixed combinations (2.3.5)
(4) meeting/teleconference/videoconference with NRG (4.2.4.)

We would like to add one suggestion as outlined below. (See section 5 transparency)


EMEA 2008 Page 5/33

EAEPC
As the representative body for parallel distribution of medicines in Europe we acknowledge the strong commitment for an integrated single market in medicines
expressed in the guidelines and hence the restrictive practice of granting derogations to single invented names for pharmaceutical products, so as to avoid artificial
partitioning of the market. The revised Directive, which had clearly the objective to further market integration in this area, should not be undermined at the first
occasion. This would be difficult to understand as, under the old regime, too many instances of separation of names have occurred, more than were strictly necessary
under linguistic or public health considerations and which, in combination with trademark law, have contributed to the partitioning of the market.
Already the practice, under the revised Directive, to allow the essentially identical medicine to be marketed under separate MAs with different brand names,
whereby one name is marketed in a given set of countries only, and the other in another group of countries, is unhelpful with respect to the objective of market
integration.
To quote some examples of unnecessary alternate names: those listed below are all current EMEA authorisations, but are not interchangeable for parallel importers,
as, although the same products, they have different EU marketing authorisation numbers:

Brand name Generic name Alternate

Aprovel irbesartan Karvea 3 presentations
Coaprovel irbesartan/hydrochlorothiazide Karvezide 2 presentations
Exelon rivastigmine Prometax 4 presentations
Mirapexin pramipexole Siffrol 3 presentations
Neoclarityn desloratidine Aerius/Azomyr 1 presentation
Plavix clopidrogel Iscover 1 presentation

The alternate names are usually to our knowledge authorised for all MS, but only exploited in a limited range.
For instance, Iscover (Plavix) is only used in Spain & Greece; Karvea (Aprovel) in Italy, Spain & Greece; Karvezide (Coaprovel) in Spain, Greece, Italy & Portugal;
Prometax (Exelon) in Spain, Italy & Portugal; Siffrol (Mirapexin) only in Austria & Germany; Aerius (Neoclarityn) in AU, FR, BE & POR; Azomyr (Neoclarityn)
only in POR. These are just a few examples - no doubt there are several more. What is common to this pattern is that the differentiation separates more or less what
is known as low-price from higher-price countries, as if linguistic capabilities and understanding were oddly connected with average price levels!
These products have been granted under the old regime, but that's just the point - we don't want this to recur, since there can be no re-boxing of eg Iscover to Plavix
as it is contrary to EMEA guidelines.
As concerns the ideas of Efpia, to grant a minor name variation under the same MA if and when linguistic considerations or the risk of confusion with an existing
name (in some countries) so require and public health could be compromised, we believe these are valid arguments.
We should, however, point at the consequences that in these cases, as a minor name variation would in the views of manufacturers be considered the same
invented name, trademark law should not stand in the way of considering such products as interchangeable for the purpose of parallel distribution, as the product
falls under the same MA, and therefore a parallel distributor should be in a position to market these products on grounds of patient safety under the name of the
product already known on the importing market.
Noting that trademark rules are not in the remit of EMEA, we would expect the Commission to make this explicitly clear in its eventual decision on this matter.
We would welcome if the Agency could, in addition, accept our request for being invited to the regular stakeholder meetings of the Name Review Group in respect
of the implementation of these guidelines; we have understood a next meeting to take place in October 2007.


EMEA 2008 Page 6/33


SPECIFIC COMMENTS ON TEXT

GUIDELINE SECTION TITLE
Line no.
1
+
paragraph
no.
Comment and Rationale Outcome
Add more rows as appropriate

1 INTRODUCTION
Line no. +
para no.
Comment and Rationale Outcome
2
nd
EFPIA
In order to remedy the situation where the Commission is of the opinion
that under the Commission Communication (J uly 1996) because the
reasons put forward by the applicant do not fall under Article 6(1) of
(EC) Regulation N726/2004 (Article 6-1) , there is room for a flexible
solution by the NRG. We encourage the EMEA to include the concept
of public health concern in one or a few Member States as ground for
granting a minor variation, in revision 5 of the Guideline.
In addition, we suggest to delete the sentence To obtain such
derogation, the M.A.H. shall provide enough evidence of its failed
efforts since language may give rise to ambiguity (What does enough
evidence mean? Which criteria would be used to confirm that efforts
failed?). Alternatively, we suggest to go back to the language used by
the Commission in its 1998 Communication (However, in exceptional
cases, in particular where the proposed brand name has been cancelled,
opposed or objected to under trademark law in a Member State,).
For proposed text in blue.
Proposed change: Based on Article 6-1 of Regulation (EC)
N726/2004, the centralised procedure therefore requires one single
invented name for the medicinal product to be authorised.
However, in exceptional cases, where the proposed trade mark has
been cancelled, opposed or objected to under trade mark law in a
Member State, the Commission may accept the existence of more




Minor variations not accepted by EC in the light of interpretation of the
Community legislation. Possibility offered to discuss the procedural
aspects of the request for derogations on trademark grounds.










1
Where applicable

EMEA 2008 Page 7/33

than one name for a single product, in order not to disadvantage
patients and their access to the concerned medicinal product in that
Member State.
Proposed text: Minor variations are considered as the same name
when the invented name has been objected to by the NRG because of
alleged public health concerns in a few Member States only.

2
nd
INTA
There seems to be no allowance for any exceptional cases beyond
where the trademark [registration] has been cancelled, opposed, or
[presumably the mark even if not registered] objected to under
trademark law in a Member State. Seems like this should be rewritten
as in exceptional cases, such as where the proposed trademark has
been cancelled, opposed or objected to . . . Adding such as would
open the door to potential other exceptional cases, whatever they may
be. For example, what if national health authorities (or other regulators)
object to a mark on other than trademark law grounds? Also consider
rewording to make it clear that cancellation and opposition applies to
registrations and applications, whereas objected to can presumably
apply to registered or unregistered marks.
Proposed change: "However, in exceptional cases, such as, where the
proposed trade mark."



Minor variations not accepted by EC in the light of interpretation of the
Community legislation. Possibility offered to discuss the procedural
aspects of the request for derogations on trade mark grounds.


3
rd
INTA
The use of standard accepted terminology is recommended when
referring to a trademark. This paragraph as well as the Guideline uses
the terms brand name, invented name, common name, scientific name,
trademark, name of the marketing authorization holder and international
non-proprietary name (INN), without any definition of these terms.
Invented name appears to be used in the document to mean trademark
and we recommend that trademark be used rather than invented
name.

NRG agreed to add relevant definitions, if available.

5
th
INTA
Although it is agreed that trademark registration is not a function of the
EMEA, it is necessary to give weight to the trademark process. Prior to
filing for trademark registration, trademark professionals do extensive
and thorough searching of prior trademark registrations and applications
as well as trademarks in use to ensure that these new trademarks will

NRG considers whether the invented name proposed for a medicinal
product could create a public-health concern or potential safety risk
independently from whether the proposed name is trademarked or not.

EMEA 2008 Page 8/33

not be confused with existing trademarks. Once applications are filed at
either national or regional trademark offices, these trademarks are
subjected to additional searching and examination by a Trademark
Examiner and the publication of pending applications for opposition by
third parties, including competitors. Therefore, trademarks that have
been through the registration process are unlikely to result in medication
errors and thus, registration status of trademarks be taken into account
as part of the EMEA review.

2 CRITERIA APPLIED WHEN REVIEWING THE ACCEPTABILITY OF PROPOSED INVENTED NAMES
2
nd
EFPIA
" When appropriate, detailed information addressing the above should
be provided within the invented name application form(s) or as part of a
justification for retaining the invented name".

It would be useful to clarify in which cases it would be appropriate to
supply detailed information about the invented name
More experience is required to provide further clarification.



2
nd
Prescrire
Asking for safety reviews of proposed names by pharmaceutical
companies.
According to this Guideline Revision 5, the EMEA expects from
pharmaceutical companies that they review the proposed invented
name, applying the criteria outlined in this guideline, before requesting
that an invented name(s) be considered and provide detailed
information addressing the above () within the invented name
application form(s) or as part of a justification for retaining the
invented name.
However, there are a variety of assessment methods for identifying
look- or sound-alike trademarks or non-proprietary names already
registered. These assessment methods comprise end-users tests by
experts, healthcare practitioners and patients, in real conditions of use.
No recommendation for selecting assessment methods is provided by
Revision 5.
Proposed change: To provide better background regarding assessment
methods for predicting risks of look-alike and sound-alike trademarks.







More experience is required to provide further clarification.
At present the NRG is not in a position to recommend specific
assessment methods.


To be considered when developing the NRG mandate and
workprogramme.

EMEA 2008 Page 9/33

With a view to transparency, the EMEA should:
- ensure scientific validation and reproducibility of assessment methods
for predicting the risks of confusion between trademark names of
medicinal products;
- explicitly indicate the recommended assessment methods for this
purpose;
- make publicly accessible those assessment methods employed by the
Name Review Group.
INSMPC
Safety reviews of proposed invented names by pharmaceutical
companies.
According to the project, the EMEA expects from pharmaceutical
companies that they review the proposed invented name, applying the
criteria outlined in this guideline, before requesting that an invented
name(s) be considered and provide detailed information addressing
the above () within the invented name application form(s) or as part
of a justification for retaining the invented name.
Although it is unclear which assessment method or which combination
of methods will be the most efficient to predicting risks of look-alike
and sound-alike medicines names, some indication for selecting
assessment methods should be provided in the guideline. The guideline
also fails to indicate how this evaluation should be carried out by the
agency groups.
There is a variety of assessment methods that may be applied to identify
look- or sound-alike commercial or non-proprietary medicines names
already registered which could be confused with a proposed new
invented name, but the most useful method comprises end-users tests by
healthcare practitioners and patients, in real world care-giving
situations.
In addition, once the possible similar names are identified, a systematic
evaluation by an expert panel should be carried out using procedures
based on failure mode and effect analysis, in order to evaluate the
possible risks of confusion, considering the factors that are actually
listed in section 2.1.1 of the guideline.
Proposed change: To provide better background regarding
assessment methods for predicting look-alike and sound-alike risks.
With a view to transparency, as a reference for auditing, and in order to






More experience is required to provide further clarification.
At present the NRG is not in a position to recommend specific
assessment methods.












EMEA 2008 Page 10/33

help pharmaceutical companies to anticipate the risk of confusing the
names of medicinal products, the EMEA should:
- ensure scientific validation and reproducibility of assessment methods
for predicting the risks of confusion between trademark names of
medicinal products, in order to further standardise them;
- explicitly indicate the recommended assessment methods for this
purpose.
Until the best method is established, it is important at least to include
the necessity of a test, with healthcare practitioners and patients, to look
for similarities of the invented names. In addition, a systematic
evaluation by an expert panel should be carried out using procedures
based on failure mode and effect analysis, in order to evaluate the
possible risks of confusion and the potential for harm taking into
account the factors listed in section 2.1.1.
- provide adequate support for research on previous above matters and
organise conferences to disseminate findings on the detection and
prevention of the risks of confusion between trademark names of
medicinal products;
- make publicly accessible those assessment methods employed by the
Name Review Group.










To be considered when developing the NRG mandate and
workprogramme.
2.1.1
8
th
bullet
EFPIA
"Orphan designation status" is listed as an aspect that is considered in
assessing the potential for confusion of invented names with existing
invented names. A clarification would be appreciated as to the
significance of orphan drug designation in the assessment of potential
confusion of invented names.
Is confusion more or less likely if one or both drugs being compared are
designated orphans?

To be developed further in a reflection paper on the basis of concrete
examples.

2.1.1
9
th
bullet
EFPIA
This bullet point should be clarified. It is not clear whether this will be
applicable for new products for which a new invented name is requested
or whether this will also be applicable for extension applications when a
new pharmaceutical form is introduced with or without a change in the
invented name.
Inclusion of the words "(Potential) New pharmaceutical forms "
It is applicable to both.
Consequences to patient in case of mix-ups with e.g. injectables
potentially more serious so development plans within same MA
important.

EMEA 2008 Page 11/33

creates confusion.
2.1.1
10
th
bullet
EFPIA
Please clarify whether the "patient" refers to all patients taking a
medicinal product or a specific group of patients within the intended
indication of the medicinal product concerned.
It is applicable in both cases. Overlap in patient population is of major
importance (i.e. where both medicines are likely to be prescribed for/used
by the same patient population or not)
2.1.1
EFPIA
The Guideline advises applicants to review their proposed names using
the same criteria as the competent authorities. Therefore, a good
understanding of the processes used by the NRG and the NCAs is
indispensable to allow applicants to conduct more appropriate research
before submission of proposed invented names.
NRG evaluates the names according to the invented name guideline and
ensures consistency in transmission of objections raised by Member
states.
2.2 EFPIA
We would be grateful if you would clarify the decision tree in Annex 1,
in particular with respect to the words not endorsed in the 2nd last
box on the left side
Where a proposed invented name includes an INN-stem as per the WHO
location, and that the medicinal product concerned is of the given
therapeutic class, the invented name would be accepted if NRG does not
identify any other public health concerns.
See revised Annex 1.
2.2 Prescrire
The Guideline Revision 4 stated: The EMEA will be monitoring
outcome of the above policy very closely and review it as appropriate
on a yearly basis.
The reasons for removing in Revision 5 the annual reviews of problems
related to the similarities with INN or their stems should be clarified.
The policy is reviewed and reported to WHO on a yearly basis.
Sentence has been reinstated.
2.2.2 We would be grateful if you would clarify the decision tree in Annex 1,
in particular with respect to the words not endorsed in the 2nd last
box on the left side
Please change the sentence to read: The NRG to the decision tree in
Annex 1.


Implemented.

2.3 Section 2.3 does no longer include the wording under 2.3.10 in the
Revision 4, which read as follows:
Invented names for annex II applications (Annex II to Commission
Regulation (EC) 1085/2003) should be the same as those of the existing
medicinal product apart from the justified qualifications/abbreviations
as mentioned in the above section 2.3.1. In case the applicant wants to
Reference made to the wording of the Variation regulation.



EMEA 2008 Page 12/33

file an extension of the application as a full stand-alone application, if
applicable according to the Legislation, a separate marketing
authorisation application must be submitted with a complete new
invented name.
The basic concept behind the wording under 2.3.10 is still valid and
should be re-introduced in the guideline.
2.3.1
1
st

EFPIA
We welcome the improvements made to this section compared to
version 4 of the Guideline, in particular the wording The invented
name should preferably consist of one word only The use of
qualifiers in principle be acceptable. The use of numbers may
also in certain cases be acceptableBut we would welcome
clarification as to the circumstances when numbers would be considered
acceptable.
It is the intention of the NRG to produce an Annex to this Guideline,
examples of qualifiers / abbreviations acceptable to the NRG.
We very much welcome the proposal to create a list of examples of
acceptable abbreviations / qualifiers.
It would be very valuable to receive this Annex as soon as possible in
order to be able to comment on it before finalisation of the revised
Guideline.

The inclusion of numbers should in principle be limited (e.g. insulin
mixtures, vaccines, ) to avoid confusion with strength and/or posology.


The inclusion of a list of acceptable qualifiers/abbreviations has been
abandoned.

2.3.1
1
st

INTA
We consider the restriction of an invented name to one word to be an
arbitrary and unjustified restriction on a trademark. A trademark
composed of more than one word is acceptable in almost all trademark
offices throughout the world, if there is no confusion with existing
trademarks. A trademark consisting of more than one word may also be
of assistance in preventing confusion. As the Guidance, uses the word
preferably, it would be appreciated if clarification could be given as to
when a trademark of more than one word would be acceptable.
This provision should also not be used to deny the use of a trademark on
a dosage form or device used in conjunction with a trademark used on
the pharmaceutical preparation. The use of a trademark for dosage
forms or devices allows consumers to distinguish effectively between
the different medicinal products and reduces the risk of confusion
The a priori restrictions on two-word names have been removed.





Agreed. See limitation described in Section 3.
2.3.1
1
st

Novartis
The invented name should preferably consist of one word only. The use
Agreed.

EMEA 2008 Page 13/33

of qualifiers/abbreviations by letters as part of the invented name
should in principle be acceptable. The use of numbers may also in
certain cases be acceptable, e.g. vaccines (see section 2.4.1.).
Novartis is pleased to see the revised wording in revision 5 (see
underlines) which alludes to NRGs flexibility to assess acceptability of
qualifiers/abbreviations on a case-by-case basis.
2.3.1
1
st

last sentence
Novartis
Novartis would welcome clarification as to the type of appropriate
justification for inclusion the NRG considers most appropriate
The a priori restrictions on two-word names have been removed.
The applicant may consider providing the NRG with an explanation for
their inclusion.
2.3.1
1
st


SP corp.
Overall, the revised text is an improvement over the current version,
primarily because the principle will now be that the use of
qualifiers/abbreviations by letters is acceptable (in the current guideline,
the principle is that the use of qualifiers/abbreviations by letters should
be avoided).
Nevertheless, the revised text is still lacking because (i) it does not
expressly accept secondary invented names or subject their refusal to
demonstrated public health reasons, (ii) the use of
qualifiers/abbreviations still has to be justified, and (iii) the
qualifiers/abbreviations should still have a meaning. The basic rule - a
single name for a same product - is not undermined by the use of a
qualifier that is an invented name or has no meaning as long as the same
qualifier is used through the Community (for instance, a line extension
with a specific pharmaceutical form). Similarly, the basic rule that the
protection of public health prohibits using confusing names is not
automatically undermined by the use of a qualifier that is an invented
name or has no meaning. Whether such qualifier is or may be harmful
to public health should be examined on a case by case basis. Thus,
qualifiers in the form of invented names or that have no meaning should
be accepted except demonstrated public health reason.
Proposed change: Add the following sentences at the end of the first
paragraph:
Qualifiers can be provided in the form of an invented name.
Qualifiers/abbreviations will be accepted unless there is a demonstrated
public health reason against that name.



The a priori restrictions on two-word names have been removed.
Identification of public health concerns lies with the NRG.




2.3.1 Novartis


EMEA 2008 Page 14/33

1
st
bullet Novartis recognizes that the list of characteristics provided is not
exhaustive, however encourages the inclusion of additional
characteristics as proposed at right in blue. All proposed names
(abbreviations or otherwise) must always be evaluated in the context of
use. Certain therapeutic areas have abbreviations which are more
commonly understood either through their use in medical education,
publications or market precedents.
For fixed combination medicinal products, the use of
qualifiers/abbreviations which provide information on the product
composition as part of the invented name can have two advantages.
First it can ease the identification of the product as being a fixed
combination (2 elements in the name; 2 elements in the product). In
addition, it increases transparency in the identification of drug
component parts. Increased transparency is preferred by medical
professionals as it assists in identifying the common denominator in
the medicinal product and the additional composition added without
having to remember a new invented name. This is of particular
importance as the number of fixed combinations in the future will
increase as more and more active substance will be available in the
public domain.
This comment should be red in conjunction with the comments on
section 2.3.5 and the justification document submitted in support of the
application for the invented name for [deleted] fixed combination,
pending approval.
Proposed change: [] (e.g. duration of action, devices, route of
administration, patient population, components) may []
















Composition added
2.3.1
1
st
bullet
SP corp.
The annex to the guidelines has not yet been provided so that it is still
unclear what categories of qualifiers/abbreviations are considered
relevant for prescription/selection purposes. Clearly, additional
information on the characteristics of a medicine is especially relevant
for prescription/selection purposes where it is marketed in several
pharmaceutical forms or several strengths.
Proposed change: Add the following sentence at the end of the first
bullet of the second paragraph:
Whether the qualifier/abbreviation provides further information on
characteristics of the medicinal product (e.g. duration of action, devices,
route of administration, patient population), which may help healthcare







EMEA 2008 Page 15/33

professionals and/or patients to prescribe/select the appropriate
medicinal product; the qualifier may also serve to identify, not
necessarily with a specific meaning, a specific form, strength, or route
of administration.
Partially implemented. See limitation described in section 3.
2.3.1
2
nd
bullet
Novartis
Qualifiers/abbreviations should be evaluated similar to the NRG
assessment sited in section 2.1.1 In the context of use - where other
factors (e.g. indication, patient populations, pharmaceutical forms,
routes of administration, strengths, setting of use, etc.) are factored in to
the assessment (see proposal in blue at right).
Proposed change: The NRG will systematically apply the criteria sited
in 2.1.1. when assessing the potential consequences to the patient and
risk to public health, in case of medication error potentially related to
the qualifier/abbreviation.
NRG does indeed apply the same criteria as described under section
2.1.1. to proposed invented names independently from the fact they
include or not a qualifier/abbreviation.

2.3.1
Last
EFPIA
proposed text: However, the applicant/MAH may include certain
qualifiers, not as part of the name of the medicinal product, but as one
of the particulars which may appear on the outer labelling in accordance
with Article 54 n) of Directive 2001/83/EC, which allows the inclusion
of instructions for use as applicable to non-prescription medicinal
products.
To designate special applications forms (e.g. OCAS), special
application devices (e.g. TURBOHALER, DISKUS) or similar features
which are specific for the respective medicinal products invented names
consisting of two invented names are acceptable as long as no safety
risk is caused by the combination of two invented names.
We had understood, at the September 2006 meeting, that it was agreed
that translations were not ruled out.
If qualifiers / abbreviations which require translations are not
acceptable, the benefit of the change introduced in the first paragraph
on page 4 under section 2.3.1 is of limited value.
Proposed change: Translations of qualifiers / abbreviations are
considered to be compliant with the single name rule so long as the
meaning of the translation is the same as the original
Article 54n) is limited to non-prescription medicines.


Mentioning of devices have indeed been allowed as part of section 2 of
the SPC, but this is not linked to Article 54n).

At the September 2006 meeting it was stated that the acceptability of
translation within a single name would be checked with EC. This was not
accepted and clarifications were introduced in rev 5.
The inclusion of a qualifier would require a separate application for that
form, strength, etc (see Section 3).
2.3.1 Prescrire
Risky amendments on abbreviations and suffixes
The current Guideline disapproves of the use of abbreviations and



EMEA 2008 Page 16/33

suffixes lacking univocal significance, and regards them as
unacceptable (See Revision 4 2.3.1). Possible exceptions, such as
the description of the route of administration (for example: IV, IM, SC),
must currently be precisely motivated by the applicant.
This draft considers that the use of qualifiers/abbreviations by letters as
part of the invented name should in principle be acceptable. Related to
the duration of action, devices, patient population, such abbreviations
and suffixes are officially intended to help the professionals of health
and/or the patients to prescribe/select the drug.
In fact they offer new avenues of publicity for pharmaceutical
companies. And the list of acceptable abbreviations and suffixes is not
yet established by the Name Review Group.
Because abbreviations and suffixes are likely to cause medication
errors, this change of position could be hazardous to European patients.
Proposed change: To control more strictly abbreviations and suffixes
of trademark names.
The EMEA should control more strictly abbreviations and suffixes of
trademark names of medicinal products because they are a frequent
cause of medication errors.
The draft guideline introduces potentially risky modifications. It is
therefore necessary to go back to a more restrictive approach regarding
use of abbreviations and suffixes.
At least, no change should be introduced to the current Guideline
(Revision 4) for safety reasons.





The NRG is aware of public health concerns in relation to the use of
qualifiers and abbreviations but is of the opinion that the proposed
revisions ensure a more balanced approach.
If, in the opinion of the NRG, the proposed name does not pose any risk
to public health there is no problem.

2.3.1 INSMPC
New management of the abbreviations and suffixes
The version in force of the Guideline disapproves the use of
abbreviations and suffixes deprived of univocal significance, and
regards them as unacceptable (See Release 4 2.3.1). Possible
exceptions, such as the description of the route of administration (for
example: IV, IM, SC), must currently be the subject of a precise
motivation from the applicant.
At the opposite, the project considers that the use of
qualifiers/abbreviations by letters as part of the invented name should
in principle be acceptable. Related to the duration of action, devices,
patient population, such abbreviations and suffixes are officially
intended to help the professionals of health and/or the patients to


If, in the opinion of the NRG, the proposed name does not pose any risk
to public health there is no problem.

EMEA 2008 Page 17/33

prescribe/select the drug.
The example list of the acceptable abbreviations and suffixes is not yet
established by the Name Review Group. Therefore, it is difficult to
appreciate up to which point the European Medicine Agency intends to
satisfy the recurring requests of the manufacturers who asked for this
modification.
Because the abbreviations and the suffixes may lead to confusion and
medication errors, this change of position could be hazardous to
European patients.
Proposed change: To address the need for safer abbreviations and
suffixes as part of the commercial names of medicinal products.
The EMEA should control more strictly the abbreviations and the
suffixes as part of the commercial names of medicinal products because
they are a frequent cause of medication errors.
No change should be introduced to the current Guideline (Release 4) for
safety reasons.
2.3.2 EFPIA
Why has the example been removed? May we assume that "Plus" is
now acceptable?
With respect to qualifiers, we refer you to our comments on Section
2.3.1. above.
It would be appreciated if specific guidance could be given and
discussed with industry as to what is considered to be a promotional
message.
For example, EFPIA believes that the use of legal symbols or
would not be considered in all circumstances as introducing a
promotional message. Use of the or logo after the trademarked
invented name is not promotional in nature, but rather a fundamental
aspect of intellectual property rights. As such, inclusion of the and
logos after the first reference to an invented name cannot constitute
advertising or promotion.
The examples have been removed as the proposed qualifiers will be
reviewed on a case-by-case basis.




Agreed.
2.3.3 EFPIA/INTA
Since no cooperation between EMEA and OHIM exists on the decision
Noted.

EMEA 2008 Page 18/33

making from NRG, it is difficult to see the relevance of this request.
Further what is the consequence if there is a discrepancy?
Clarification is required as to the relationship of the proposed/approved
trademark registration and the use of upper-case letters. Trademarks are
registered in all block letters and such registrations provide the right to
use such trademarks with all block letters or with initial capitals.
Additionally, as the Introduction to the Guidance states that [t]he
review of trademarks is not under the EMEA remit since other
authorities are responsible for such procedure both at the National and
European level, a requirement solely related to the trademark
registration lacks consistency.

In the opinion of the NRG the use of capitals may in certain
circumstances put emphasis on part of the name and consequentially be
considered promotional.
As this is rather to be assessed in the context of mock-ups specimen
review by QRD, the NRG proposes to delete this criterion from this
Guideline.

2.3.4 EFPIA
Applicants may do so as long as no substantial safety risk is caused by
such insertion. This should be made clear.
Combination names should be treated as any other names from an
assessment perspective. We would welcome a discussion on how
EMEA analyses and determines health and safety risks in combination
product invented names.
If the whole name is included this increases the likelihood for the wrong
medicine to being selected from computer listings in electronic
prescriptions. The consequential potential harm to the patient should be
evaluated.
NRG believes current wording is appropriate. Company may justify
deviation from the Guideline.
2.3.4
Novartis
1
st
sentence: Novartis is pleased to see the revised wording in revision 5
(see underline) which alludes to NRGs flexibility to assess
acceptability of proposed combination product names on a case-by-case
basis.
If the whole name is included this increases the likelihood for the wrong
medicine to being selected from computer listings in electronic
prescriptions. The consequential potential harm to the patient should be
evaluated.
NRG believes current wording is appropriate. Company may justify
deviation from the Guideline.
2.3.4 Novartis
2
nd
sentence: Combination product names should be evaluated the same
way as the NRG assessment sited in section 2.1.1 In the context of use
- where other factors (e.g. indication, patient populations,
pharmaceutical forms, routes of administration, strengths, setting of use,
etc.) are factored in to the assessment. Novartis therefore believes that
the applicant should have the opportunity to insert the whole invented
name of the individual active substance(s) in the proposed invented
name for the fixed combination if he can justify that overall the name of
the combination is sufficiently different (e.g. by use of adequate
qualifier/abbreviation)
In addition, this statement refers to the spelling of the name only what
Names for fixed combinations are assessed as any other name, but
including the whole name implicitly makes them potentially confusing
with each other.


Work in progress. Workshop with patients, HCP and industry might be
considered in the future. Wording allows for flexibility.



EMEA 2008 Page 19/33

might have limited value. For example rosiglitazone is registered as a
monotherapy with the invented name AVANDIA and as fixed
combination with metforin with the invented name of
AVANDAMET. Novartis does not believe that a name such as
AVANDIAMET (not allowed according to this paragraph) would
convey more risk than AVANDAMET (the approved name for the
combination) on the basis that it contains all the letters of the original
brand name.
Overall we believe that the more information a proposed combination
product invented name can convey about the product composition the
better. This increases transparency in identification of the drug
component parts. Increased transparency is preferred by medical
professionals as it assists in identifying the common denominator in
the medicinal product and the additional composition added without
having to remember an entirely new invented name. Patient compliance
may also be improved as patients familiar with a mono-therapy brand
will have a familiarity with the combination product brand already
through this link.
Therefore Novartis recommend that the second paragraph of section
2.3.5 is deleted in the favour of the first paragraph.







2.3.4 Prescrire
Still more errors in the pipeline with trademark names of fixed
combination medicinal products
Because EMEA has been reported medication errors on these type of
medicinal products, trademarks of fixed combination products had to
be in Revision 4 completely different from the combination of the
trademark name borne by the individual active substances of the fixed
combination.
Surprisingly, this concern has been removed from Revision 5 with the
only requirement that combination trademarks be sufficiently different
from these trademark names or those of other combinations.
In the absence of evaluation by end-users in situations of care, this
provision is extremely likely to lead the firms to propose commercial
names strongly evoking those already known to prescribers.
As fixed combinations often have little therapeutic interest, exposing
patients to additional risks of medication errors would be unacceptable.



Work in progress. Workshop with patients, HCP an Industry might be
considered in the future.

EMEA 2008 Page 20/33

Proposed change: To control more strictly the trademark names of
fixed combination medicinal products.
The EMEA should control more strictly the trademark names of fixed
combination medicinal products because they are a frequent cause of
medication errors.
At least, no change should be introduced to the current Guideline
(Revision 4).
2.3.4 INSMPC
Proposed invented names of fixed combination medicinal products
Because EMEA has been reported medication errors on these type of
medicinal products, the proposed invented names of fixed combination
medicinal products were asked in Release 4 to be completely different
from the combination of the commercial name borne by the individual
active substances of the fixed combination.
This concern has been removed from the Release 5 with the result that
from now it will be enough that they are sufficiently different from
these trademark names or those of other associations comprising them.
This may provoke additional risks of medication errors.
Proposed change: To control more strictly the proposed invented
names of fixed combination medicinal products.
The EMEA should control more strictly the trademark names of fixed
combination medicinal products because they are a frequent cause of
medication errors.
At least, no change should be introduced to the current Guideline
(Release 4), less permissive.



Work in progress. Workshop with patients, HCP and industry might be
considered in the future.
2.4.1 EFPIA
The treatment of the description of serotypes appears inconsistent with
the treatment of other qualifiers/abbreviations in Section 2.3.1. where
the need for translation will lead to a rejection. Please clarify.
The Guideline refers to when different types of antigens are added.
Clarification is requested as to whether this would cover a situation
where the source of the antigens is switched.
This is a product specific concern which should not be looked at together
with other types of qualifiers.

2.4.4 EFPIA
For non-prescription medicinal products, we will refer to any comments
Noted.

EMEA 2008 Page 21/33

you may receive from AESGP, as interested party.
2.4.4 AESGP
In light of the definition of non-prescription medicines, this paragraph
seems to be worded in a too negative manner. The legal status should be
better recognised and should reflect the current legislation. According to
Article 71.1 of Directive 2001/83/EC, as amended:
Medicinal products shall be subject to medical prescription where
they:
- are likely to present a danger either directly or indirectly, even
when used correctly, if utilized without medical supervision, or
- are frequently and to a very wide extent used incorrectly, and as a
result are likely to present a direct or indirect danger to human
health, or
- contain substances or preparations thereof, the activity and/or
adverse reactions of which require further investigation, or
- are normally prescribed by a doctor to be administered
parenterally.

According to Article 72, the remainder are non-prescription.
This means that the normal classification status is non-prescription
unless the medicine meets one of the four above-mentioned criteria.
For non-prescription medicinal products, due account should be
given to the specific legal status of these medicinal products as defined
in Articles 71 and 72 of Directive 2001/83/EC as amended. Because of
the absence of a prescription and/or the intervention by a healthcare
professional, the The (invented) name should aid selection/identification
of the product by the patient and should minimise the risk of
inappropriate use. In view of the above considerations, the specific
criteria described under sections 2.3.1, 2.3.2 and 2.3.5 may not apply
here. An appropriate justification in this regard should be provided to
the NRG for consideration. Qualifiers/abbreviations which are normally
not understood outside a specific language area (e.g. English) and which
therefore require translation to be understood in the respective a wide
range of EU Member States are not acceptable as part of the (invented)
name since this would be incompatible with the single name rule of
Article 6(1) of Regulation (EC) Nr 726/2004. However, the











Implemented.



Reference to section 2.3.2 has been replaced by acknowledging that it is
acceptable for an invented name to have a positive connotation or to be
informative.

Implemented, slightly reworded

EMEA 2008 Page 22/33

applicant/MAH may justify inclusion of certain qualifiers to be
translated, not as part of the name of the medicinal product, but as one
of the particulars which may appear on the outer labelling in accordance
with Article 54 n) of Directive 2001/83/EC, which allows the inclusion
of instructions for use in case of non-prescription medicinal products.
The relevance of such inclusion will be assessed by the CHMP during
the evaluation process.
2.4.4 Prescrire
Unacceptable endorsement of umbrella trademarks for non-
prescription drugs
Prescrire is strongly opposed to umbrella names covering several
medicinal products of different compositions, which do not allow
patients to identify clearly the substances they use.
Revision 5 not only facilitates derogations to the use of abbreviations
and suffixes (see also our comment no.2.3.1) or of fixed combinations
(see also our comment no.2.3.5) for trademarks that are directly
advertised to the general public, but it provides for additional terms to
be included in trademarks, alleging that it should be considered as
instructions for use to be introduced in the commercial name.
These instructions for use are particulars to be printed on the outer
packaging, according to Article 54(n) of Directive 2004/27/EC. Nothing
allows the applicant to incorporate them in the commercial name.
Failing to consider Article 54(n) of Directive 2004/27/EC, the EMEA
implicitly endorses umbrella names for non-prescription medicinal
products.
Proposed change: To withdraw exemptions for umbrella trademark
names and restrict their use in non-prescription medicinal products
The EMEA should consider that an umbrella trademark name used for
different medicines, each of them with one or several active
pharmaceutical ingredients having different effects, can lead to
confusion. Patients and professionals may not be aware of the
difference, which may give rise to potentially serious errors.
Therefore, the EMEA must:
- withdraw these exemptions from the standard rules for trademarks of
non-prescription medicinal products due to the medication errors which
This aspect is not addressed in the proposed text of the IN guideline.
More experience is needed.








The legislation does not prohibit two- word invented names either.











EMEA 2008 Page 23/33

they might induce;
- launch an in-depth evaluation of the risks related to umbrella names of
non-prescription medicinal products within the European Union, in
order to better appraise the possibility of restricting or banning their use.
2.4.4 INSMPC
Proposed invented names for non-prescription medicinal products
The addition of complementary terms in the trademark name will be
allowed, alleging that it should be considered as instructions of
employment to be introduced in the commercial name.
However, these instructions of employment constitute only one of the
labelling mentions to be made on the outer packaging in this precise
case, according to Article 54(n) of Directive 2004/27/EC. Nothing
authorizes the applicant to incorporate them in the commercial name.
This new disposition will contribute to widespread umbrella names,
which, under the same name, expose the patients to medicinal products
of different compositions and do not allow them any more to identify
clearly the substances that they use.
Proposed change: To withdrawn rules favouring umbrella
trademark names
The European Medicine Agency should consider that an umbrella
trademark name for a different combination of medicines with several
active pharmaceutical ingredients might lead to confusion. Patients and
professionals may not be aware of the difference, which may give rise
to errors that can lead to unexpected consequences.
Therefore, the European Medicine Agency is urged to withdraw these
exemptions, not consistent with Directive 2004/27/EC, for non-
prescription medicinal products from the standard evaluation of the
proposed invented names of medicinal products, due to the medication
errors, which they might induce.
This aspect is not addressed in the proposed text of the IN guideline.
More experience is needed.

2.4.6
1
st
bullet
EFPIA
We assume that this paragraph will allow for the use of modified INN
names recommended by WHO (e.g., sodium, maleate).
Would it be acceptable to use an official shortened version of corporate
identity within the name of the medicinal product, as was done for the
Agreed

Agreed

EMEA 2008 Page 24/33

EMEA approvals of irbesartan BMS or caspofungin MSD?


2.4.6 EGA
The name of the MAH within the name of the medicinal product
should correspond to the official name of the MAH as presented in the
proof of establishment of the applicant/MAH.
This is a narrow interpretation, and in some member states it has been
accepted that shortened forms of the company name exists as part of the
product name. An example is the German Company CT-Arzneimittel
has always been shortened to CT, this is used for marketing products
in Germany and is well-known there. The legal entity (e.g. S.A, SPRL,
Ltd etc.) of the MAH never appears in the name of the medicinal
product either.
Proposed change: The name of the MAH within the name of the
medicinal product should be all or part of the official name of the MAH
as presented in the proof of establishment of the applicant/MAH

Agreed.






Implemented.

3 REGULATORY ASPECTS RELATED TO THE ACCEPTABILITY OF PROPOSED INVENTED NAMES
1
st
EFPIA
Revision 4 of the Guideline specified that for extension of applications
a different qualifier could be used.
We propose to keep this possibility clearly stated in this section.
Indeed, section 2.3.1 highlights the benefit of the use of a qualifier as
follows:
[] the qualifier/abbreviation provides further information on
characteristics of the medicinal product (e.g. duration of action, devices,
route of administration, patient population), which may help healthcare
professionals and/or patients to prescribe/select the appropriate
medicinal product
This is particularly true for extension of applications, for example to
highlight 2 different populations, for example adult and paediatric,
targeted with 2 different dosages.
Proposed change: Invented names for variation/extension applications
should be the same as those of the existing medicinal product apart
from the justified qualifications/abbreviations as mentioned in the
Reference is made to the wording of the Variation Regulation.






EMEA 2008 Page 25/33

above section 2.3.1.

4 COMPOSITION AND EMEA PROCEDURE FOR CHECKING PROPOSED NAMES
1
st
, 2
nd
and
3
rd

EFPIA
The EMEA operates a procedure to ensure that objections raised by
National Competent Authorities against the (invented) name of a
medicinal product due to potential safety risks or other criteria as
defined in section 2 of this document are identified at an early point.
The practical experience of the EMEA to date has shown that this early
intervention and checking of the invented name(s) has permitted
marketing authorisations to be granted without delays related to
invented name issues.
The procedure for review of invented names can be subdivided into
various phases, namely submission, consultation, discussion/adoption
or rejection, and communication/clarification and follow-up.
Proposed text: The NRG ensures that the safety risk assessment
concerning invented names is conducted at an early point and with
sufficient flexibility in order to avoid safety risks while endeavouring to
reduce the current high rate of rejection.
There is no clear mention in the guideline of the possibility to justify the
rejected preferred invented name while back-up names initially
submitted have been accepted.
Room should be given for the possibility to justify retaining the 1
st

invented name if rejected without automatic selection of an acceptable
back-up name.
We propose to identify such scenario in Section 4.2.5 Rejection by
NRG/CHMP of a proposed invented name 2/:
In case preferred name has been rejected but a back-up name accepted,
this does not lead to automatic selection of the acceptable back-up
name; it is still possible to justify retaining the preferred invented name
addressing specifically all the objections raised.










Objections are based on public health grounds and process allows
companies to overturn these with suitable justifications, independently of
it being a preferred or back-up name.
4.2.2 INTA
The Guidance states that..."It should be noted that invented names(s)
may be checked against authorized, applied for, suspended and
revoked/withdrawn medicinal products in the different Member States
according to the relevant national legislation."






EMEA 2008 Page 26/33

Although we agree that similarity to recently suspended, revoked or
withdrawn products may be of significance, there should be a specific
time frame as to the number of years that products no longer in the
marketplace will be considered. For the sake of predictability for the
applicants of marketing authorizations and to avoid unnecessary
rejection of names on the basis of very old inactive marketing
authorizations, EMEA should only consider names used in
revoked/withdrawn marketing authorizations for a defined period of
time following the date of revocation/withdrawal. Article 19 of The
World Trade Organizations Agreement on Trade-related Intellectual
Property Rights proposes that three years of non-use should have
occurred before cancellation of a trademark can take place.
Consequently, three years non-use of a trademark is now recognized in
national trademark law as sufficient basis for a cancellation action. We
recommend the adoption of three years as the defined time period.
However, even if three years is not an acceptable period to EMEA, a
defined period is recommended.
Under discussion.







4.2.3 EFPIA
Could clarification be given on the process used by the NRG to evaluate
the confusing similarity between trade marks? What analyses are
performed to determine sound-alike and look-alike similarity and who
carries out the analyses?
If databases are used, which names do they contain? Are they publicly
available?

NRG ensures consistency of transmission of objections raised and this is
independent on which methods are applied at the national level.

Compilation of websites and retrievable information in progress.
4.2.4 EFPIA
For the applicant to be able to prepare a justification for retaining an
invented name after initial non-acceptance by the NRG it is necessary to
have the full information concerning possible confusions.
We therefore request that more detailed outcome feedback be sent to the
applicant. In particular this concerns exact information regarding where
confusing products (products identified by the NRG as liable to cause
confusion) are registered and a list of the concerned languages where
confusion occurs.

The level of information provided has already been increased recently.
The aim of the NRG is to further increase the details on objections over
time.




4.2.5 EFPIA
In the event the name is rejected a meeting/


EMEA 2008 Page 27/33

teleconference/videoconference provide the best forum for a more
thorough and quicker resolution of the issues (better than can be
conducted in writing).
An opportunity to hold such meeting
meeting/teleconference/videoconference with the NRG should therefore
be provided to further discuss the justification for retaining a proposed
invented name.
Proposed additional text:
Following non-acceptance of an invented name the applicant may
request to join a meeting/teleconference/videoconference with the NRG
(for their agenda item only) to discuss justification of the proposed
invented name and their concerns.
To be discussed in the context of NRG mandate and rules of procedure.
4.2.5
Last
EFPIA
The possibility for engaging the CHMP in the discussion is welcomed.
However, some further guidance is required in order to address the
following questions:
- will the issues to the CHMP be addressed in writing or in an oral
explanation
- who will decide whether an issue will be brought forward to the
CHMP ?
at what stage will CHMP be involved (after 1
st
rejection, after
submission of justification?).
What are the formal steps which the CHMP will follow in the
procedure?
This has always been the case even if not acknowledged in the IN
guideline
The company is to request this can be orally and/or in writing.

To be discussed in the context of NRG mandate and rules of procedure.
4.2.5
Item 4/
Novartis
Novartis would like to request clarity on this point: Is this a kind of
arbitration procedure? What exactly happens at the CHMP? Who
presents the case? What are the timelines for the process and final
decision?

To be discussed in the context of NRG mandate and rules of procedure.
4.2.5
Item 4/
Prescrire
Rejection by NRG/CHMP of a proposed invented name
Revision 5 provides for pharmaceutical companies who do not have
their proposed trademark names accepted by the Name Review Group
to ask the CHMP to reconsider the proposal. This new provision,
although presented as exceptional, weakens the decisions of the Name
.




EMEA 2008 Page 28/33

Review Group.
Proposed change: To reinforce authority of the Name Review Group
Paragraph no.4.2.5/4 must be withdrawn in order to respect the
prerogatives and the mission of the Name Review Group
To be discussed in the context of NRG mandate and rules of procedure.
4.2.6.2 Prescrire
Reporting of medication errors due to trademark names
The pharmacovigilance system and Periodic Safety Update Reports
(PSUR) are the current EMEA tolls for medication errors due to the
trademark names of medicinal products.
However, as specified in the recommendations, medication errors due to
trademark names do not necessarily result in adverse effects (ADR),
therefore they are not reported to the pharmacovigilance system.
Since Revision 5 introduces particular rules on trademark names of non-
prescription medicinal products directly advertised to the general public
(see no.2.4.4), patients should be allowed to report medication errors
due to trademark names directly to the EMEA.
In order to promote European-wide standards for safe medication
practices, the Council of Europe recommends to share and disseminate
data and strategies for prevention and risk reduction* and to ensure
that all medication error reports related to its relevant missions, such
as naming, labelling, packaging, advertising of medicinal products, are
shared with the European Medicine Agency by European medication
error reporting system**.
Proposed change: To facilitate reporting of medication errors due to
the trademark names
Healthcare professionals and patients should be encouraged to report
medication errors due to trademark names, even if they do not result in
adverse effects.
Procedures and specific reporting forms should be established by the
EMEA in order to provide a better insight on this type of medication
error.
EMEA should draw on experience from voluntary and independent
medication error reporting programmes as recommended by the Council
of Europe. The Name Review Group should pay special attention to the















To be discussed in the context of NRG mandate and rules of procedure.


EMEA 2008 Page 29/33

results of thorough analysis of medication errors reported to the safe
medication practices centres, together with their proposals for
prevention,
* Council of Europe Recommendation Rec (2006)7 of the Committee
of Ministers to member states on management of patient safety and
prevention of adverse events in health care adopted 24 May 2006.
** Council of Europe Expert Group on Safe Medication Practices
Creation of a better medication safety culture in Europe: Building up
safe medication practices Preliminarily version available as from 19
March 2007: 257 pages.
4.2.6.2 INSMPC
Report of medication errors due to invented names of medicinal
products.
The pharmacovigilance system and Periodic Safety Update Reports
(PSUR), are the current sources for the European Medicine Agency on
medication errors due to the invented names of medicinal products.
However, as specified in the recommendations, medication errors due to
the trademark names do not necessarily result in adverse effects (ADR),
therefore they are not reported to the pharmacovigilance system.
In order to promote Europe-wide standards for safe medication
practices, the Council of Europe recommends to share and disseminate
data and strategies for prevention and risk reduction* and to ensure
that all medication error reports related to its relevant missions, such
as naming, labelling, packaging, advertising of medicinal products, are
shared with the European Medicine Agency by European medication
error reporting system**.
* Council of Europe Recommendation Rec(2006)7 of the Committee
of Ministers to member states on management of patient safety and
prevention of adverse events in health care adopted 24 May 2006.
** Council of Europe Expert Group on Safe Medication Practices
Creation of a better medication safety culture in Europe: Building up
safe medication practices Preliminarily version available as from 19
March 2007: 257 pages.
Proposed change: To facilitate reporting of medication errors due to



















EMEA 2008 Page 30/33

the trademark names
Procedures and specific reporting forms should be established by the
EMEA in order to provide a better insight on this type of medication
error.
EMEA should draw on experience from voluntary and independent
medication error reporting programmes as recommended by the Council
of Europe. The Name Review Group should pay special attention to the
results of thorough analysis of medication errors reported to the safe
medication practices centres, together with their proposals for
prevention.
To be discussed in the context of NRG mandate and rules of procedure.

5 EFPIA
Proposed addition: If available the NRG shall also publish, on an annual
basis, statistical and qualitative information on the outcome of the
national name clearance processes in the EU member states in order to
benchmark its flexible and reasonable checking approach.

This is at discretion of national authorities.
5 Roche
Apart from publishing statistical information on the outcome of review
procedures we feel that it would be helpful to publish also the results of
discussions on safety issues arising from similarity of the proposed
mark with prior marks. Such publications will create more reliable
guidance for applicants than abstract rules and they will contribute to
the consistency of the decision practice of the NRG / CHMP.
In the evaluation of conflicts under trademark law jurisprudence of the
relevant courts plays an essential role for trademark practitioners. A
similar system would equally work well in the regulatory field.
Proposed text: Insert as third paragraph of chapter 5:
If during NRG/CHMP review safety issues were debated which arose
from similarity between the submitted name and cited name(s) the
outcome will be published as far as it is a matter of public interest. The
publication shall include
(1) the submitted name
(2) the cited name(s)
(3) a short reasoning why the safety risk was considered as

To be discussed in the context of NRG mandate and rules of procedure.

EMEA 2008 Page 31/33

acceptable or not acceptable, referring to the criteria of section
2.1.1
5 Prescrire
Transparency is inadequately addressed, in contradiction with
Article 126(c) of Directive 2004/27/EC
The monthly CHMP report only includes statistical information on the
outcome of the NRG review of proposed names, but information on the
trademark names prone to confusion is lacking.
One can understand that the names suggested by the companies are not
revealed for commercial reasons, but there is no reason to hold secret
the known medication errors due to confusions between trademark
names.
Implementing transparency requirements in Article 126(c) of Directive
2004/27/EC (7) is not the only issue. Indeed, failure to disclose
information about a known risk of confusion between drug names may
be harmful to European citizens. It means deliberately exposing them to
known risks, which goes against the public health mission of the
EMEA.
Proposed change: To make known risks of confusion between
trademark names publicly available
As part of postmarketing surveillance, public health protection and
respect of Article 126(c) of Directive 2004/27/EC on transparency,
requires that:
- medication errors due to confusion between trademark names of
medicines be reported in the minutes of CHMP monthly reports;
- a routinely updated list of pairs of trademark names leading to
medication errors in all EU countries be set up;
- this list be made accessible on the EMEA web site;
- safety alerts be circulated whenever adverse effects result from
medication errors due to confusion between trademark names.
To be discussed in the context of NRG mandate and rules of procedure.
5 INSMPC
Transparency should be more aggressively addressed
The monthly CHMP report only includes statistical information on the

To be discussed in the context of NRG mandate and rules of procedure.

EMEA 2008 Page 32/33


EMEA 2008 Page 33/33
outcome of the NRG review of proposed names, but information on the
trademark names prone to confusion is lacking.
One can understand that the names suggested by the companies are not
revealed for commercial reasons, but there is no reason to hold secret
the known medication errors due to confusions between trademark
names.
Implementing transparency requirements in Article 126(c) of Directive
2004/27/EC (7) is not the only issue. Indeed, failure to disclose
information about a known risk of confusion between drug names may
be harmful to European citizens. It means deliberately exposing them to
known risks, which goes against the public health mission of the
EMEA.
Proposed change: To make public the known risks of confusion
between invented names of medicinal products.
As part of post marketing surveillance, public health protection and the
respect of Article 126(c) of Directive 2004/27/EC on transparency,
require:
- to report medication errors due to confusion between trademark names
of medicines in the minutes of CHMP monthly reports;
- to set up and permanently update a list of pairs of trademark names
leading to medication errors in all European Union countries;
- to make this list accessible on the EMEA web site;
- and to circulate safety alerts whenever adverse effects result from
medication errors due to confusion between trademark names.
EFPIA
Please clarify what is meant by "not endorsed" in the 2nd last box.
Should it be no public health concern?
See revised INN decision trees.