MRP & DCP step by steb instructions how to apply and how the procedures are conducted
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1 MRP & DCP step by steb instructions how to apply and how the procedures are conducted 06 May 2013 Dubrovnik, Croatia Dr. Peter Bachmann Head of Unit Coordination Group European and International Affairs Federal Institute for Drugs (BfArM) and Chair CMDh c/o EMA, London
2 Federal Institute for Drugs European Pharmaceutical Legislation 2
3 EU / EEA (+ Iceland, Norway, Liechtenstein) United in Diversity Political union of 27 Member States 501 Mio inhabitants 23 official languages 3
4 Types of MA in the EU/EEA central national MA valid for the EU MA valid for a single EEA-MS 4
5 National Marketing Authorisation MRP and DCP Scope 5
6 Scope of MRP/DCP: National Marketing Authorisation - (1) new active substances (if not mandatory for the centralised procedure) known active substances under Article 8(3) biological medicinal products (incl. biosimilar) (if not mandatory for the centralised procedure) generic medicinal products to national (and centralised) authorised reference medicinal products well established use (WEU) ( bibliographic applications ) 6
7 Scope of MRP/DCP: National Marketing Authorisation - (2) cont. known active substances in new combination informed consent to national MA (line) extension applications to national authorisations homeopathics traditional herbal medicinal products 7
8 Where to apply for a national MA? Competent Authority (CA) of a Member State (MS) of the EU/EEA Who will grant a national MA? CA of the MS 8
9 Procedures for a MA-Application central national MRP/DCP single one MA valid for the EC more than one EEA-MS MA for only one EEA-MS 9
10 MRP and DCP 10
11 What is the Mutual Recognition Procedure (MRP) and the Decentralised Procedure (DCP)? Federal Institute for Drugs describes the procedure to get national MAs in MSs of the EEA for the same medicinal product mandatory procedures work sharing between MS 11
12 Article 17 of Directive 2001/83/EC Applications for marketing authorisations in two or more Member States in respect of the same medicinal product shall be submitted in accordance with Articles 27 to Where a Member State notes that another marketing authorisation application for the same medicinal product is being examined in another Member State, the Member State concerned shall decline to assess the application and shall advise the applicant that Articles 27 to 39 apply. 12
13 Article 18 of Directive 2001/83/EC Where a Member State is informed in accordance with Article 8(3)(1) that another Member State has authorised a medicinal product which is the subject of a marketing authorisation application in the Member State concerned, it shall reject the application unless it was submitted in compliance with Articles 27 to
14 Same medicinal product? Federal Institute for Drugs If and and Same qualitative and quantitative active ingredient There may be the differences in excipients provided that there is no impact on safety and efficacy Same pharmaceutical form, but Link between companies all legal entities all license holders companies who have agreed to act in a concerted action = MRP/DCP (Commission Communication July 1998) 14
15 MRP and DCP - (1) Two routes to receive a MA for the same medicinal product 1. Mutual recognition procedure (MRP) where the medicinal product has already received in a MS a MA at the time of application 2. Decentralised procedure (DCP) where the medicinal product has not received in a MS a MA at the time of application or MRP & DCP
16 MRP and DCP (2) MRP Interpretation (RMS): (with regard to the medicinal product and duplicate application ) 1. You have to use the first national MA for the MRP or 2. You need a national MA to start the MRP, but you don t have to use an existing MA (submission of an updated copy -application for DCP) 16
17 MRP and DCP - (3) Federal Institute for Drugs CMDh Recommendations on Multiple/Duplicate Applications in Mutual Recognition and Decentralised Procedures (Rev 3, June 2007) CMDh Q&A No 1: The CMDh has agreed that a duplicate application of a medicinal product authorised via the Mutual Recognition Procedure can be accepted via the Decentralised Procedure, provided that the same Reference Member State is used. 17
18 MRP and DCP DCP (= Decentralised Procedure) DCP/MRP BAH-WiDi
19 DCP - Overview 1. Pre-procedural Step scientific/regulatory advice validation 2. Assessment step I 120 days incl. clock-stop 3. Assessment step II 90 days 4. National step to grant MA 30 day incl. Public AR DCP/MRP BAH-WiDi
20 DCP - flow chart - (1) Revision 4, March Pre-procedural Step Before Day - 14 Pre-submission discussions between Applicant and RMS Day - 14 Submission of the dossier to RMS and CMSs Validation of the application DCP/MRP BAH-WiDi
21 Pre-submission discussions. S L O T S!!!!!! tool for workplanning two models currently in use/discussion continium quantum 21
22 22
23 23
24 current problems high number of cancellations or delays 54 % - with 34 % total cancellation ongoing discussion with trade associations 24
25 Validation (1) Administrative validation (!) therefore no validation of the content of the application Reduction of national requirements a lot of effort but not totally sucessful Still additional national requirements for some of the MSs 25
26 National requirements Federal Institute for Drugs NO YES 26
27 Validation (2) Federal Institute for Drugs Validation issues 27
28 Application not received/modules are missing Missing/incorrect fee Application form/cover letter not signed/not signed with original signature The application form is incorrect (eg. information missing, incorrect type of procedure, legal basis incorrect, incorrect reference medicinal product, reference to an European reference medicinal product although there is a nationally authorised medicinal product) Documents in accordance with NtA, vol. 2B are missing or absence not justified (eq. Braille, Consultation with Target Patient Groups, Pharmacovigilance System, Environmental Risk Assessment, Specific Requirements for Different Application Types, Paediatric Regulation(where applicable)) Annexes to the application form are missing or absence not justified (eg Declaration from the QP, TSE certificates for excipients of animal origin) Manufacturing licenses, GMP certificates and/or import licenses have not been updated or are missing. Proposed batch releaser is situated outside the EEA ASMF and/or letter of access to ASMF missing or incorrect version of the ASMF has been submitted Confirmation that identical dossiers are submitted in both RMS and the CMS is missing.... DCP/MRP BAH-WiDi
29 progress Federal Institute for Drugs Two categories validation issues which prevent the start (closed list!) e.g. only national requirements which are published on the CMDh website procedure can be started, but non-validation issues has to be solved with day 60 response (MRP) or day 106 response (DCP) at latest 29
30 DCP - flow chart - (2) 2. Assessment step I 120 days Day 0 RMS starts the procedure and the assessment of the dossier Day 70 RMS forwards PrAR, SmPC, PL and labelling to CMSs and Applicant Day 100 CMSs send comments to RMS and Applicant RMS may consult CMS to close procedure Day 105 RMS close the procedure or stops the clock DCP/MRP BAH-WiDi
31 DCP - flow chart - (3a) Clock-off period recommended period of 3 months, which could be extended for further 3 months and if justified DCP/MRP BAH-WiDi
32 Reasons for long clock-stop on request from the applicant!!! new or additional BE-study/studies missing studies GMP / GCP inspection wait for the outcome of ongoing discussions Don t Submit Premature Dossiers! Improve Quality of the Dossier! 32
33 DCP - flow chart - (3b) Clock-off period recommended period of 3 months, which could be extended for further 3 months and if justified Applicant send draft response to RMS if not letter to RMS about the submission date of the final response Applicant agree with the RMS the date of submission of the final response Applicant submit final response document to MS DCP/MRP BAH-WiDi
34 DCP - flow chart - (4) Day 106 valid submission of the response of the applicant received = Restart of the procedure RMS updates PrAR to prepare draft AR (DAR), draft SmPC, draft PL and draft labelling Day 120 if consensus RMS close procedure if consensus not reached DCP/MRP BAH-WiDi
35 DCP - flow chart - (5) 3. Assessment step II 90 days Day 120 RMS sends draft AR, draft SmPC, draft PL and draft labelling to CMSs and Applicant Day 145 CMSs send (final) comments on draft AR,... Day 150 if consensus RMS close procedure no consensus RMS to dicuss items with applicant (and CMS) and prepare of a report on outstanding issues to the CMD (until Day 180) Day 195 Break-out Session CMSs send final comments DCP/MRP BAH-WiDi
36 DCP - flow chart - (6) Day 210 closure of the procedure mutual approval or disagreement and referral to the Coordination Group (CMDh) (based on potential serious risk to public health ) 36
37 DCP - flow chart - (7) 4a. National step to grant MA 30 days Day 215 (95) Applicant sends national translations of SmPC, PL and labelling Day 240 (120) granting of the national MA This timeframe of 30 days is equally valid for the CMS in the MRP!!! DCP/MRP BAH-WiDi
38 MRP and DCP MRP RU-MRP (Repeat Use MRP) DCP/MRP BAH-WiDi
39 MRP - flow chart - (1) 1. Validation Before Day - 14 Submission of Dossier by Applicant to CMS Submission of Assessment Report to CMS (and Applicant) Day - 14 Start of the Automatic Validation Def. automatic : not against is in agreement DCP/MRP BAH-WiDi
40 Why Validation Issues? - (1) CMDh Procedural Advice on Repeat-Use (Rev. 7, July 2011) Granted MA are with proofen safety and efficacy, but new application in the CMS!!!! is the dossier still up-todate changed Guidelines (e.g. bioequivalence) new legislation (e.g. pharmacovigilance) science still state of the art? status of the SmPC/PL? are the indications state of the art? patient consultation? 40
41 Why Validation Issues? - (2) cont. all (national) variation are finished? ongoing (national) renewal? still conditions to fulfil from the time of approval? (updated) assessment report available? change of assessor change of clinical philosopy prescription status 41
42 Why Validation Issues? - (3) legal basis of the application (10a, 10b) outdated GMP- and CEP-certificates problems related with ASMF unknown GCP-problems and therefore an update is necessary before submission takes time and resources but no security against surprises during the MR-Procedure!!! 42
43 MRP - flow chart - (2) 2. The 90 Days-Procedure Day 0 RMS starts the procedure Day 50 CMS send comments to RMS and Applicant Day 58 Draft Applicant s Response Document = ARD to RMS Day 60/68 Final ARD and Assessor s Response Document (if applicable) to CMS Day 75 CMS comments on ARD to RMS Response of Applicant to CMS Possibility of a Break-out Session n- comments and answers circles DCP/MRP BAH-WiDi
44 MRP - flow chart - (3) Day 85 Day 90 finally proposed SmPC to CMS Final comments of CMS closure of the procedure mutual approval or disagreement and referral to the Coordination Group (CMDh) (based on potential serious risk to public health ) DCP/MRP BAH-WiDi
45 MRP - flow chart - (4) if CMS 3. National step 30 days Day 95 Day 120 Applicant sends national translations of SmPC, PL and labelling granting of the national MA if RMS: 3. update of the national MA + Public AR DCP/MRP BAH-WiDi
46 Why update of the existing MA? Federal Institute for Drugs MRP changes to the dossier, SmPC, PL, labelling during the procedure need to update the existing national MA Repeat-Use MRP Procedure only between RMS and new CMS no changes are possible during the procedure yes or no-decision for the new MS old MS have to agree with changes MAH agree to introduce the changes ask for via a variation 46
47 Public AR Transparency of Marketing Authorisations Federal Institute for Drugs MA and SmPC public available Public Assessment Report (PAR) is public accessible without any information of a commercially confidential nature a justification for each indication applied for shall be given in MRP/DCP written and updated (Variations, Renewal) by the RMS for the CMS Consultation between RMS and Applicant on the content of the PAR (CMDh-BPG) Summary in lay language 47
48 DCP - flow chart - (8) 4b. Public AR (CMDh BPG FOR THE PUBLIC ASSESSMENT REPORT IN THE DECENTRALISED AND MUTUAL RECOGNITION PROCEDURE January 2006 ) End of MRP (Day 90) or DCP (Day 210) = Day 0 Day 10 Day 20 Day 25 Day 60 RMS send draft of PAR to Applicant comments on PAR to RMS - RMS to check answers of Applicant - prepare final PAR - publication of the PAR on the website of the Heads of Medicinal Agencies (HMA) DCP/MRP BAH-WiDi
49 Federal Institute for Drugs 49
50 the new product index (1) Federal Institute for Drugs 50
51 the new product index (2) Federal Institute for Drugs 51
52 52
53 (new) development Federal Institute for Drugs for historic reasons only positively concluded DCP are published 30 days after the end of the procedure (exemption: CMDh-Referral) new policy: rejected DCP are published 30 days after closing of the procedure, starting list of involved MS will be published negativ PAR will be published DCP-applications withdrawn after Day 120 will be published (in preparation) 53
54 (BfArM) Federal Institute for Drugs... special thanks to all CMDh- Members/Alternates/Experts for the hard work and time spend... many thanks for your kind attention The BfArM The BfArM is a Federal is a Federal Institute Institute within within the the portfolio portfolio of of the the Federal Federal Ministry of of Health 54
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