nrg guideline in europe new consultation · 2015-04-28 · draft guideline – section 6 limitation...
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NRG Guideline in Europe New consultation
PTMG conference – Vienna – Austria
2-4 October 2013
Joëlle SANIT-HUGOT
Senior Director Legal, Trade Mark
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INTRODUCTION
● New Draft Guideline on the acceptability of invented names for human
medicinal products – issued for comments on 7 June 2013 by European
Medicines Agency (EMA)
● Concerns medicinal products processed through the Centralised
procedure
● EMA set up the Committee for Medicinal Products for Human Use (CHMP)
which set up the Name Review Group (NRG) – Composed of
representatives of EU Member States – chaired by EMA Representative
(Isabelle Moulon)
● NRG to perform the review of Invented Names (IN)
● NRG to update the Guideline on the acceptability of Invented Names for
human medicinal products processed through the Centralised Procedure
INTRODUCTION
● Legal Basis : Guideline developed in accordance with :
● Art. 6 of Regulation (EC) N° 726/2004 (31 March 2004)
● Art. 1 (20) of Directive 2001 / 83 / EC (6 November 2001)
● 6th Update (First Guideline = 1998) – Deadline for comments : 30 August
2013
● Invented Names rejection rates
● 2009 = 53 % of all names submitted for approval were rejected
● 2010 = 56 %
● 2011 = 48 %
● 2012 = 43 %
● 2013 (until July) = 46 %
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INTRODUCTION
● Aim of new draft Guideline
● Refer to experience gathered since last Guideline (Rev. 5 - 2007)
● Provide further clarifications :
• With regard to the requirements for acceptability and submission of
proposed invented names of medicinal products
• With regard to specific aspects of the criteria applied by NRG when
reviewing the acceptability of proposed IN to address safety and
public health concerns, International Non-Proprietary Names (INN)
issues and product-specific concerns in proposed IN
● References to take into account
● New draft Guideline on Invented Names + NRG Position paper on re-use
of IN – 23 May 2011 – EMA/648795/2009
● EMA Pre-submission and Post-authorisation Guidance documents
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WHAT IS CONFIRMED ? BASICS
● Single Invented Name requirement
● IN valid (trademark, regulatory, linguistic standpoint) in 28 Member States
+ Iceland, Norway, Liechtenstein
● 24 languages in EU
● No flexibility to adjust an IN in a Member State except if Trademark
conflict
● No consideration for IP Rights / trademark registrations
● Purpose of Name review by EMA : protection of public health
● IN must not create a public-health concern or potential safety risks
● EMA to review all kinds of « Invented Names » / Clarification of the term
● Pure Invented Name – Ex. MULTAQ® (atrial fibrillation)
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WHAT IS CONFIRMED ? BASICS
● Combination of INN (International Non-Proprietary Name) / generic name /
common name or scientific name + Name of Marketing Authorisation
Holder / Applicant Company – Ex Irbesartan BMS (Hypertension)
● Combination of INN (International Non- Proprietary Name) / generic name /
common name or scientific name + Trademark
● IN cannot be a mixture of legally available options
● Qualifiers / Abbreviations (in use with IN) – Ex. PANTOLOC CONTROL
(gastroesophageal reflux) – ZYPREXA VELOTAB (Bipolar disorder – schizophrenia)
● By letters should in principle be acceptable - BUT use of a single letter or
number = potential issue / risk of confusion with strength / posology
● Should be understandable in all 24 languages of EU Member States
● Should not convey promotional message
● Non prescription-medicines : NRG to consider other elements such as
labelling and pack-design
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SUBMISSION OF INVENTED NAMES BY APPLICANT / MARKETING AUTHORISATION HOLDER Draft Guideline – Section 6
● Submission of electronic request form with Proposed Invented Names +
● Draft summary of products characteristics (SmPC) or product profile
● Submission of any other relevant information / all available supporting
documentation (results of research in connection to similar INs)
● Applicant to conduct its own review of Invented Names HOW ?
● No methodology validated by EMA
● Advantages / Drawbacks
● Reminder : IN reviewed by 28 Member States + European Commission +
World Health Organisation (WHO) on a case-by-case basis
• Analysis varies by Member States (checking performed with National
Compendiums / National Marketing Autorisation listings / Expert
Panel)
• No POCA (Phonetic Orthographic Computer Algorithm) analysis
• No Name simulation studies
Up to NRG to reach consensus among Member States
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SUBMISSION OF INVENTED NAMES BY APPLICANT / MARKETING AUTHORISATION HOLDER Draft Guideline – Section 6
● My Recommendation - Applicant should :
• Provide information on Name Screening
• Provide Safety testing / Regulatory Risk Assessment
• ▲ Expensive : EU = 28 Member States - not possible to cover all of
them
● Submission of Justifications : Ex. inclusion of a Qualifier, multiple
applications (for public health or co-marketing reasons), deviation from the
Guideline (similarity with INN), addition and description of a Medical
Device …)
● Early submission of IN
● When ? – Rev. 5 = « submission at the earliest 18 months prior to the
planned submission of Marketing Authorisation Application » = deleted
from new draft ?
• ▲ Only 6 meetings per year / Review Time = 2 – 3 months
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SUBMISSION OF INVENTED NAMES BY APPLICANT / MARKETING AUTHORISATION HOLDER Draft Guideline – Section 6
● Number of IN to be proposed for review per NRG session = ?
● Rev. 5 : Up to 4 names - reviewed simultaneously by NRG - can be
proposed (per Marketing Authorisation Application – MAA)
● Interpretation of Rev. 5 = Submission of 4 names per NRG session ?
● Current EMA Request Form = out of 4 names, 1 accepted IN allows 3 new
proposals ; 2 accepted IN allows 2 new proposals …
● New draft = ? – probably limited only up to 2 invented names
• More workload for Applicants and for NRG ?
● Reduction of the number of IN accepted by NRG per Marketing
Autorisation Application to only 2 IN
● Rev. 5 : Up to 4 invented names accepted per MAA
● New draft = only up to 2 invented names accepted per MAA
• Important change = Difficulties to achieve a global trademark
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SUBMISSION OF INVENTED NAMES BY APPLICANT / MARKETING AUTHORISATION HOLDER Draft Guideline – Section 6
● Limitation on the possibility for the Applicants to submit other names for
review
● When 2 IN are accepted for a MAA no new request for review of additional
names will be allowed by NRG
● ONLY on duly justified grounds (not defined in the draft guideline) NRG
may accept to assess other names
● Applicant to indicate which 2 IN are maintained for a given MAA
• Flexibility needed due to other Health Authorities’ concerns
• Freedom to operate ?
● Rejection of IN by NRG during the review process
● Applicant can submit new INs to NRG until 2 IN are accepted for the MAA
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SUBMISSION OF INVENTED NAMES BY APPLICANT / MARKETING AUTHORISATION HOLDER Draft Guideline – Section 6
● In case no IN is approved on time (one month prior to decision of CHMP
on the granting of Marketing Authorisation)
● IN imposed by CHMP will be common name or scientific name or INN +
Name of the Marketing Authorisation Holder
● ▲ IN to be endorsed by NRG prior to the final decision of CHMP
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SUBMISSION OF INVENTED NAMES BY APPLICANT / MARKETING AUTHORISATION HOLDER Draft Guideline – Section 4 + NRG Position Paper 23 May 2011
Draft Guideline – Reference to NRG Position Paper of 23 May 2011 (EMA/648795/2009) in force
since 1st January 2012
● Background : Invented Names accepted by NRG since 1996, held in NRG
database, BUT unused by Applicants
● Difficulties for Applicants to find new acceptable names (no disclosure of
unused names by NRG for confidentiality reason)
● Solutions required to clean EMA Database
● Introduction of a 3-year limit on acceptance of IN
● Starting from NRG’s final outcome of initial assessment of the
acceptability of IN
● One extension of time possible for further 3 years upon written request
from Applicant to NRG 3 months before expiry date (Applicant to monitor
the deadline)
● Further extension possible in exceptional cases upon justification by
Applicant (not defined)
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SUBMISSION OF INVENTED NAMES BY APPLICANT / MARKETING AUTHORISATION HOLDER Draft Guideline – Section 4 + NRG Position Paper 23 May 2011
● Removal by EMA of previously accepted IN from EMA Database
● Removal of all IN accepted by NRG before 31 december 2009
● For IN accepted after 1st january 2010 = Applicants to request
reconfirmation from NRG to preserve their IN beyond 2013
● Re-Use of Invented Names
● Applicable only to a name previously accepted by NRG
● Acceptability of an IN is strictly linked to a product profile
● Decision on re-use taken by NRG on a case-by-case basis
● Criteria applied for assessment
• Name used in a Marketing Authorisation Application
• MA not granted
• MA granted : product marketed ? / never marketed ?
• Name not used in a Marketing Authorisation Application
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SUBMISSION OF INVENTED NAMES BY APPLICANT / MARKETING AUTHORISATION HOLDER Draft Guideline – Section 4 + NRG Position Paper 23 May 2011
• Re-use for a product with same product profile
• Re-use for a product with different product profile
● ▲ Main concern for Applicants = public awareness of the IN on Internet
(publication by Applicant / EMA/ other stakeholders)
● « The re-use would only be deemed acceptable provided that the risks to
public health do not outweigh the benefit of facilitating the access of the
medicinal product to the market » (NRG Position Paper on Re-use)
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CRITERIA APPLIED BY NRG TO REVIEW INVENTED NAMES – Addressing safety and public health concerns Draft Guideline Section 4
● Main basis for review – Principle unchanged
● IN should not be liable to cause confusion in print, handwriting or speech
with the IN of another existing medicinal product
● Rejection rate based on similarity with other IN
• 2012 = 84 % / Until July 2013 = 82 %
● NRG to take into consideration Product profile (▲ overlapping
characteristics increase risk for name confusion)
● Scope of checking
Checking performed against authorised, applied for, suspended and revoked
/ withdrawn medicinal products / Marketing Authorisations in 28 Member
States whatever the route of authorisation (centralised / decentralised /
mutual recognition procedure)
● Withdrawn / revoked marketing authorisation : a period of 5 years should
have elapsed after the official invalidity of the Marketing Authorisation
according to national legislation
● 5 year period can be reduced or extended at NRG’s discretion
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CRITERIA APPLIED BY NRG TO REVIEW INVENTED NAMES – Addressing safety and public health concerns Draft Guideline Section 4
● Consideration to be given to phonetics and pronunciation of an IN
● No submission of IN similar to each other (e.g. differing in one character) –
▲increase of likelihood of confusion
● No submission of IN with offensive or bad connotation in any of the EU
languages (▲ no more information from NRG to the Applicant)
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CRITERIA APPLIED BY NRG TO REVIEW INVENTED NAMES - Addressing INN concerns Draft Guideline Section 4
● An Invented Name shall not be liable to cause confusion with the common
names / International Non-Proprietary Names (INNs) – 2 issues :
● Assessing the similarity between an IN and an INN referring to the
product itself OR a different INN (associated to another product)
● Assessing the inclusion of an INN stem into an IN (quid stem position ?)
Ex. cef- (antibiotics – INN = cefotaxime) / -prazole (antiulcer – INN =
lansoprazole)
● Simplification of New Draft Guideline : refers only to World Health
Assembly Resolution (WHA46.19)
● Applicant to review INN similarity / INN stem inclusion
● Withdrawal of Decision Trees annexed to Rev. 5 (IN similar to INN / IN
containing an INN stem) : to be re-integrated to help Applicant in the
analysis ?
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CRITERIA APPLIED BY NRG TO REVIEW INVENTED NAMES - Addressing INN concerns Draft Guideline Section 4
● Similarity with INN and inclusion of INN stems
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WITHDRAWN
CRITERIA APPLIED BY NRG TO REVIEW INVENTED NAMES - Addressing product-specific concerns Draft Guideline – Section 4
● Vaccines / Adding a new serotype
No longer necessary to include the pharmaceutical form to the IN / new
format of IN = IN + X (number of serotypes)
● Combination of INN + Name of Marketing Authorisation Holder / Applicant
OR INN + Trademark)
● No punctuation marks in between the INN and the name of the MAH /
Applicant OR Trademark (exception : fixed combination – multiple INNs to
be separated by « / »)
● Radiopharmaceutical products
Avoid inclusion of target organs in IN (to prevent misleading connotations in
case of extension of the indication including new target organs)
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CRITERIA APPLIED BY NRG TO REVIEW INVENTED NAMES - Addressing product-specific concerns Draft Guideline – Section 4
● Orphan drugs
Applicants to provide detailed information on the specific setting of
dispensation and on the target population
● Hybrid medicinal product
IN to be different from IN of the reference medicinal product when the hybrid
product differs in pharmaceutical form, strength, expression of active
substances and /or indication
● Multiple Applications
IN must be sufficiently different from each other to avoid confusion with each
other
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POST AUTHORISATION ACTIVITIES / PREVENTION OF MEDICATION ERRORS Draft Guideline – Section 6
● NRG to reinforce the prevention of medication errors by developing
collaboration with :
● Quality Review of Documents (QRD) Group – on the checking of mock-
ups and specimens
● Pharmacovigilance Risk Assessment Committee (PRAC) - on the review
of risk management plan
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FUTURE DEVELOPMENT
● Not mentioned in the Draft Guideline but existing rules to include ?
● Validity of IN = at the present point of time - ▲ last minute rejection +
objections may be raised at any time prior or after the granting of the MA
● Consultation on the draft Guideline
● Active Participation to consultation
● Pharmaceutical Associations (EU, National) and Companies have
commented the Draft – main concern = reduction of the number of IN per
MAA
● Comments to be published on EMA Website
● Outcome = ?
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Thank you for your attention!
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