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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● 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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● 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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● 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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● 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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● 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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• 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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