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Kiev, 04/12/2007 Analysis of EU MRP/DCP procedures regarding to generic applications Dr.Raimonds Lozda, FMS Baltic Ltd.

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Presentation on theme: "Kiev, 04/12/2007 Analysis of EU MRP/DCP procedures regarding to generic applications Dr.Raimonds Lozda, FMS Baltic Ltd."— Presentation transcript:

1 Kiev, 04/12/2007 Analysis of EU MRP/DCP procedures regarding to generic applications Dr.Raimonds Lozda, FMS Baltic Ltd

2 Kiev, 04/12/2007 EU Authorities National Regulatory Authorities CPMP Committee for Proprietary Medicinal Products EMEA The European Agency for the Evaluation of Medicinal Products Enterprise DG(Enterprise Directorate-General) Unit F2: Pharmaceuticals Regulatory framework and Market authorisations EU-Commission

3 Kiev, 04/12/2007 AIMS of the EU-Commission – Ensure a high level of protection of public health – Bring about a single market in pharmaceuticals – Foster a stable and predictable environment for pharmaceutical innovation

4 Kiev, 04/12/2007 Regulatory policy and tasks of the EC – Ensure appropriate standards of consumer protection – Maintain, update and simplify EU pharmaceutical legislation – Draft new legislation – Provide guidance on pharmaceutical legislation and ensure that it is properly implemented within the EU – Support the mutual recognition of national marketing Authorisations – Check that centralised authorisations comply with community law and turn the EMEA opinion into a binding decision for all the Member States (issue the authorization)

5 Kiev, 04/12/2007 Legally binding acts and soft laws Legally binding acts: Regulation (e.g. EEC No. 2309/93) Directive (e.g. 2001/83/EC) Decision (e.g. N°74/1999) Soft laws: Resolution Communication (e.g. 98/C229/03) Guideline (e.g. GCP, GMP, GLP) Notice to Applicants (e.g. Notice to Applicants NTA)

6 Kiev, 04/12/2007 Regulation vs. Directive Regulations (EEC) no. 726/2004 (EMEA): – Binding legislation which automatically enters into force in all Member States Directives 2004/27/EC and 2004/24/EC – Require transposition into national law (normally within 18 months) leaving to national authorities decision as to form and means for achieving desired aim of law

7 Kiev, 04/12/2007 Legally binding acts regulating MRP/DCP MA legislation in the EU In 2001 a comprehensive reform of the EU pharmaceutical legislation, commonly referred to as Review 2001 took place. The following directive was published: Directive 2001/83/EC on human medicines including rules for marketing authorisation (MRP and DP), authorisation procedure, manufacture and importation, labelling, pharmacovigilance as well as advertising

8 Kiev, 04/12/2007 Objectives of the review: – guarantee a high level of public health protection for Europeans – create basic legal conditions for improving the competitiveness of the European pharmaceutical industry – meet the challenge of EU-enlargement – rationalise and simplify the medicines authorisation systems Review 2001

9 Kiev, 04/12/2007 Finalisation of the Review 2001 Regulation 726/2004 Community procedures for authorisation of medicinal products for human and veterinary use – centralised procedure (replaces Regulation 2309/93) Directive 2004/27/EC amending Directive 2001/83/EC related to medicinal products for human use Directive 2004/24/EC amending Directive 2001/83/EC related to traditional herbal medicinal products – The most parts of the regulation came in force on 20 November 2005 – all EU member states had to implement the revised directives by 30 October, 2005

10 Kiev, 04/12/2007 Objectives for the finalisation: – New measures to eliminate the remaining obstacles to free movement – Revision of MRP: Formalisation of Cooperation between Member States – Clear definition of medicinal products to avoid borderline products – Clear position, which products have to be authorised by centralised procedure – Renewal and invalidity of marketing authorisation after granting of MA – Harmonisation of data protection – Facilitating the access of generics to the market – Specialities for bio-similars – Quality aspect for MP was enlarged to requirements on active substances – Proper use of medicinal products

11 Kiev, 04/12/2007 Which procedures are possible for generics ? Mutual Recognition Procedure (MRP) Decentralised Procedure (DCP)

12 Kiev, 04/12/2007 THE MUTUAL RECOGNITION PROCEDURE Generic Case Study

13 Kiev, 04/12/2007 What is a generic medicine in EU ? reference medicinal product shall mean a medicinal product authorised under Article 6, in accordance with the provisions of Article 8; generic medicinal product shall mean a medicinal product which has the same qualitative and quantitativecomposition in active substances and the same pharmaceutical form as the reference medicinal product, and whose bioequivalence with the reference medicinal product has been demonstrated by appropriate bioavailability studies. The different salts, esters, ethers, isomers, mixtures of isomers, complexes or derivatives of an active substance shall be considered to be the same active substance, unless they differ significantly in properties with regard to safety and/or efficacy. In such cases, additional information providing proof of the safety and/or efficacy of the various salts, esters or derivatives of an authorised active substance must be supplied by the applicant. The various immediate-release oral pharmaceutical forms shall be considered to be one and the same pharmaceutical form. Bioavailability studies need not be required of the applicant if he can demonstrate that the generic medicinal product meets the relevant criteria as defined in the appropriate detailed guidelines. DIRECTIVE 2004/27/EC

14 Kiev, 04/12/2007 What is Data Exclusivity ? Data Exclusivity guarantees market protection for branded pharmaceuticals by preventing health authorities from accepting applications for generic medicines during a given period (6 or 10 years after the first authorisation in the EU of theoriginator product).

15 Kiev, 04/12/2007 Data exclusivity in EU for all MA-application after the : – The new data protection is valid: for all products - independent of the approval procedure: 10 (8+2) years market exclusivity 8 years data protection and receive a MA – the generic MAH is not allowed to place his product on the market until 10 years have expired 11 (8+2+1) for a new indication with a significant clinical benefit in comparison with existing therapies, a year supplementary protection is given

16 Kiev, 04/12/2007 What is Bolar Provision? A Bolar provision allows all development, testing and experimental work required for the registration of a generic medicine to take place before expiry of the term of the patent protection of the original product. EU generic companies are forced to develop their products in countries with Bolar provisions and then import after patent expiry. Bolar implentation in some countries – UK October 2005, DE September 2005, IT March 2005 LV March 2007.

17 Kiev, 04/12/2007 If a national marketing authorisation exists, only the Mutual Recognition Procedure is possible MRP What does it mean ? If you have a MA in one or more countries and in order to get a MA in some other country the only possibility is : MRP

18 Kiev, 04/12/2007 … except Medicinal products subject to the centralized procedure Line-extensions for non-harmonized products approved by national procedures (Only PL,LT possible ?) Medicinal products not yet reviewed, e.g. products under reevaluation (No such products presently) Homeopathic products MRP exceptions

19 Kiev, 04/12/2007 What are MRP difficulties ? RMS – reference member state Presently all EU national Agencies dealing with MRP are booked till 2009 Points to consider Scientific expertise and knowledge in the therapeutic area Reputation in the regulatory community Reliability Duration of assessment Good project management and co-ordination skills Transparency of communication Market size of RMS (1st approval offers the chance for an early entry into a big market)

20 Kiev, 04/12/2007 Applications in Concerned Member States The applications must be submitted to the competent authorities of all CMS accompanied by the following confirmations: the dossier is identical to that approved by the RMS the Summary of Product Characteristics (SPC) is Identical dossier and SPC as submitted are identical for all CMS CMS- concerned member state

21 Kiev, 04/12/2007 MRP flow-chart ~ 330 days total

22 Kiev, 04/12/2007 MRP process description – Submission of the dossier (CTD, SPC, PIL, label) only in the Reference Member State (RMS) for national marketing authorisation – after 210 d: first marketing authorisation: RMS sends assessment-report to Concerned Member State (CMS); national process – In further 90 days resolution and agreement to dossier and final SPC – Further national marketing authorisation in 30 calendar days (translation etc)

23 Kiev, 04/12/2007 MRP flow-chart

24 Kiev, 04/12/2007 MRP process description

25 Kiev, 04/12/2007 THE DECENTRALIZED PROCEDURE Generic Case Study

26 Kiev, 04/12/2007 If no marketing authorisation exists, the decentralised procedure can be choosen if the authorisation is planned in more than one Member State DCP

27 Kiev, 04/12/2007 MRP flow-chart ~ 210 days total

28 Kiev, 04/12/2007 DCP process description – Submission of the dossier (CTD, SPC, PIL, label) in the RMS and all CMS – After 210 days: national marketing authorisations in RMS and CMS

29 Kiev, 04/12/2007 DCP process description

30 Kiev, 04/12/2007 MRP, DCP issues

31 Kiev, 04/12/2007 1) Preparation of dossier - Language Validation of the dossier according to NTA What are main threats in MRP, DCP ?

32 Kiev, 04/12/2007 1) Preparation of dossier – number of copies EE Modules 4 and 5 should be provided on CD-ROM version only. Paper copy should be available on request LT Mutual Recognition Procedure where LT acts as CMS: a paper copy of 1&2 modules +all modules on CD-ROM LV Additional copy of all modules on CD – ROM Validation of the dossier according to NTA What are main threats in MRP, DCP ?

33 Kiev, 04/12/2007 2) Samples, mock-ups EE in the presentation authorised in RMS LV 2 samples in the form of final sales presentation of the medicinal product Validation of the dossier according to NTA What are main threats in MRP, DCP ?

34 Kiev, 04/12/2007 Validation of the dossier other issues 1) When and where to pay ? 2) What documents support payment ? Payments Reference product Brand name issues What are main threats in MRP, DCP ?

35 Kiev, 04/12/2007 What are main threats in MRP, DCP ? During the procedure Strict follow to timeframes set in procedure The duration of the clock stop can be strongly influenced by the applicant !!!

36 Kiev, 04/12/2007 What are main threats in MRP, DCP ? During the procedure User test (Art. 59 (3) and 61(1) on the patient information has to be done – here the tests only in one EU-language is necessary –the result has to be presented in English

37 Kiev, 04/12/2007 The package leaflet shall reflect the results of consultations with target patient groups to ensure that it is legible, clear and easy to use and The results of assessment carried out …with target patient groups shall also be provided to the competent authority What is the User test ? What are main threats in MRP, DCP ? During the procedure The action which increases the cost of MA

38 Kiev, 04/12/2007 What are main threats in MRP, DCP ? National phase Almost never completed within 30 days MRP and 90 DCP Not only the SPC but also the package leaflet (PL) and labelling has to be identical – the blue box concept will allow adequate national information like national marketing authorisation number, special warnings -proposals of labelling, patient information and summary of product characteristics has to be submitted in one language for applications for marketing authorisation - the translations of the agreed SPS, PL and labelling have to be submitted at latest 5 days after the end of the procedure to the national competent authorities

39 Kiev, 04/12/2007 On the packaging the name of the product has to be printed in Braille-format Mock-ups of the packaging including the Braille signs have to be submitted with the SmPC Check the product - hospital or not National phase What are main threats in MRP, DCP ?

40 Kiev, 04/12/2007 What are main threats in MRP, DCP ? National phase Common Baltic Pack – reality ? Nightmare blue box too big.

41 Kiev, 04/12/2007 MRP, DCP statistics- generics

42 Kiev, 04/12/2007 MRP, DCP statistics- generics

43 Kiev, 04/12/2007 MRP, DCP statistics

44 Kiev, 04/12/2007 MRP, DCP statistics

45 Kiev, 04/12/2007 MRP, DCP statistics

46 Kiev, 04/12/2007 MRP, DCP statistics

47 Kiev, 04/12/2007 MRP, DCP statistics

48 Kiev, 04/12/2007 MRP, DCP statistics

49 Kiev, 04/12/2007 MRP, DCP statistics

50 Kiev, 04/12/2007 MRP, DCP statistics

51 Kiev, 04/12/2007 MRP, DCP tips and tricks What to do if you have a product you want to sell to different clients ? Same dossier (photocopies) Same legal basis Art 8.3 (i) or Art 10.1 Dir 2001/83/EC Different trade names Same or linked applicant or different applicant Multiple applications

52 Kiev, 04/12/2007 MRP, DCP tips and tricks What to do if a product was under MRP/DCP but you want to add one country where is no MA ? Find a company which will Apply as MAH and after granting transfer MA

53 Kiev, 04/12/2007 Key lessons from MRP,DCP 1)To go your own is not the cheapest way 2)Local contact in each country is mandatory 3)Paper work is too complicated that SOPs (Standart Operation Procedures) on spot are of high relevance

54 Kiev, 04/12/2007 Contact details: Tel:


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