Joint NRG/Interested Parties meeting on Invented names Invented Name Review Group 2005-2006 Zaide FRIAS Zaide FRIAS Chairperson NRG Chairperson NRG Regulatory Affairs and Organisational Regulatory Affairs and Organisational support support 11 September 2006 11 September 2006 European Medicines Agency 1 1
Agenda Topics • Introduction • Introduction • NRG Composition/checking procedure • NRG Composition/checking procedure • Criteria addressing safety concerns • Criteria addressing safety concerns • Issues of qualifiers and bad connotation • Issues of qualifiers and bad connotation • Fixed combinations, extensions and pro- -drug drug • Fixed combinations, extensions and pro • INN/INN stem health concerns • INN/INN stem health concerns • Product specific concerns • Product specific concerns • A.O.B • A.O.B European Medicines Agency 2 2
1 – Introduction and scope European Medicines Agency 3 3
Reasons for Revision of I N guideline � Update in line with new Community legislation � Update in line with new Community legislation � Single invented name requirement in Centralised Single invented name requirement in Centralised � procedure and definitions of name of a medicinal procedure and definitions of name of a medicinal product and common name product and common name � Clarify specific aspects related to the to Clarify specific aspects related to the to ‘ ‘non non- - � prescription’ ’ and and ‘ ‘generic/hybrid/similar biological generic/hybrid/similar biological’ ’ prescription medicinal products. [see disclaimer] [see disclaimer] medicinal products. � Update taking into account practice and experience � Update taking into account practice and experience gathered within the NRG since revision 4 gathered within the NRG since revision 4 � Complexity within enlarged EU Complexity within enlarged EU � � Increased transparency measures � Increased transparency measures European Medicines Agency 4 4
IN Guideline Update legal basis Article 6 of Regulation (EC) No 726/2004 , Article 6 of Regulation (EC) No 726/2004 , • “each application for the authorisation of a medicinal each application for the authorisation of a medicinal • “ product (… …), otherwise than ), otherwise than in exceptional cases relating in exceptional cases relating product ( to the application of the law on trade marks, shall include , shall include to the application of the law on trade marks the use of a single name for the medicinal product.” the use of a single name for the medicinal product. ” Article 1(20) of Directive 2001/83/EC , as amended: Article 1(20) of Directive 2001/83/EC , as amended: • ‘the name of the medicinal product the name of the medicinal product may be either an may be either an • ‘ invented name not liable to confusion with the common invented name not liable to confusion with the common name, or a common name or scientific name name, or a common name or scientific name accompanied by a trade mark or the name of the accompanied by a trade mark or the name of the marketing authorisation holder” ”. . marketing authorisation holder European Medicines Agency 5 5
IN Guideline - Single name rule - CURRENT CURRENT Derogation by EC in exceptional cases where Derogation by EC in exceptional cases where • the proposed trade mark has been the proposed trade mark has been • cancelled, opposed or objected to under cancelled, opposed or objected to under invented name law in a Member State invented name law in a Member State • Sufficient evidence is given by MAH Sufficient evidence is given by MAH • • Not introduce partitioning of the EU market Not introduce partitioning of the EU market • European Medicines Agency 6 6
IN Guideline - Single name rule - EC INITIATIVE EC INITIATIVE - acknowledge impact of enlargement in terms of acknowledge impact of enlargement in terms of - finding acceptable names across EU finding acceptable names across EU - reason to re reason to re- -assess application of derogation in a assess application of derogation in a - way that increases the options available way that increases the options available - invited EMEA to reflect on workable solution by invited EMEA to reflect on workable solution by - review of various parameters incl. review of various parameters incl. - Number of member states objecting on trade mark Number of member states objecting on trade mark - grounds grounds - Resulting number of names for a single product Resulting number of names for a single product - - Degree of similarity/difference between the names Degree of similarity/difference between the names - - Standard of proof of objections on trademark Standard of proof of objections on trademark - grounds grounds European Medicines Agency 7 7
Invented Name Guideline - - Revision 4 Revision 4 Invented Name Guideline Disclaimer: Disclaimer: EMEA will endeavour to update and make publicly available EMEA will endeavour to update and make publicly available any new guidance or criteria for review of invented names new guidance or criteria for review of invented names any in a timely manner by means of updating regularly this in a timely manner by means of updating regularly this guideline or, if necessary separate or standalone EMEA guideline or, if necessary separate or standalone EMEA public statements. This will be the case for instance for public statements. This will be the case for instance for invented names for “ “non non- -prescription prescription” ” and and “ “generics generics” ” invented names for medicinal products for which further detailed guidance should medicinal products for which further detailed guidance should ….. .. … … be developed … be developed European Medicines Agency 8 8
2 – NRG Composition and Procedure for checking proposed invented names European Medicines Agency 9 9
NRG composition Romance Germanic Slavic Composition Composition Chair (EMEA) + MS representatives (contact points and participants) + European Commission + EMEA representatives + Experts (DK) + WHO Baltic Uralic Greek Semitic 10 Meeting participant
EMEA website -Transparency Info under CHMP – – Other associated groups Other associated groups Info under CHMP � Role � Role NEW NEW � Mandate, rules of procedure, work programme � Mandate, rules of procedure, work programme (not currently available) (not currently available) � Composition � Composition � Members (Attendees and Contact points) � Members (Attendees and Contact points) NEW NEW European Medicines Agency 11 11
NRG Procedure Checking invented names Flow Chart Flow Chart Invented Name Invented Name REJECTION REJECTION NRG NRG Submission Submission CHMP CHMP Consultation Consultation Discussion/ Discussion/ Applicant/MAH Applicant/MAH IN IN Adoption of Adoption of MS, WHO, EC MS, WHO, EC communication communication request NRG TOD request NRG TOD Outcome Outcome Invented Name Invented Name ACCEPTANCE ACCEPTANCE European Medicines Agency 12 12
NRG Procedure Checking invented names SUBMISSION of Invented names SUBMISSION of Invented names Submission Submission dates dates published Intended published Intended Invented name Invented name Preferably 4 - - 6 6 Preferably 4 Up to 4 to 4 Up (no August (no August � request form � multiple multiple request form months prior months prior NRG NRG invented NRG@emea.eu.int invented NRG@emea.eu.int applications applications meeting) meeting) MAA (max 12 MAA (max 12 names NEW names NEW if applicable applicable if months before) months before) European Medicines Agency 13 13
NRG Procedure Checking invented names CONSULTATION CONSULTATION with Member States, WHO, EC with Member States, WHO, EC Proposed invented name and Proposed invented name and background doc sent to NRG background doc sent to NRG contact points (MS, EC and contact points (MS, EC and WHO) WHO) NRG contact points to NRG contact points to Checking against authorised, Checking against authorised, provide objections/comments provide objections/comments applied for, suspended and applied for, suspended and on grounds of safety on grounds of safety revoked/withdrawn medicinal revoked/withdrawn medicinal concerns or other within 30 within 30 concerns or other products according to relevant products according to relevant days days national legislation national legislation European Medicines Agency 14 14
NRG Procedure Checking invented names Monday CHMP week Monday CHMP week NRG NRG Discussion/ Discussion/ Outcome Outcome Develop other Develop other Review of objections Review of objections recommendations Endorsement / recommendations Endorsement / Revise Revise received based received based rejection rejection on IN guideline on IN guideline Invented Name Invented Name of objections of objections Guideline Guideline European Medicines Agency 15 15
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