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The role and tasks of the National Medicines Agencies

The role and tasks of the National Medicines Agencies. EU legislation for VMPs Instanbul, 18 – 19 April 2011 Jiří Bureš Institute for State Control of Veterinary Biologicals and Medicines.

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The role and tasks of the National Medicines Agencies

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  1. The role and tasks of the National Medicines Agencies EU legislation for VMPs Instanbul, 18 – 19 April 2011 Jiří Bureš Institute for State Control of Veterinary Biologicals and Medicines

  2. The views presented here are my personal views and they are not to be intepreted as the views of the Czech NCA

  3. EU and its legislation (1) • EU • a body of treaties, law and court judgements which operates alongside the legal systems of the European Union´s member states. It has direct effect within the EU's member states and, where conflict occurs, takes precedence over national law • Supremacy • Direct effect • Horizontal (Treaties, Regulations, Decisions) • Vertical (Directives) • „Four freedoms“

  4. EU and its legislation (2) • EU legislation • Primary • Secondary • ECJ Decisions • Soft law • Recommendations • Notice to Applicants, Guide, Guidelines, Notes for Guidance, Points to Consider • Communications • Opinions • National legislation

  5. ?? Medicinal product (MP) • Definition – Dir.2001/82/EC as amended by Dir. 2004/28/EC • any substance or combination of substances presented as having properties for treating or preventing disease in animals;OR • any substance or combination of substances which may be used in, or administered to, animals with a view either to making a medicinal diagnosis, or to restoring, correcting or modifying physiological functions by exerting a pharmacological, immunological or metabolic action, or to making a medical diagnosis

  6. Medicinal product „by presentation“ (1) • a substance presented as having properties either for treating disease in animals or for preventing disease in animals. • The nature of a medicinal product considered by the European Court of Justice on a number of occasions.  • There are policy reasons for not having too broad or too narrow an interpretation of medicinal products. It is recognised that there may be some overlap between a medicinal product by presentation and a medicinal product by function.

  7. Medicinal product „by presentation“ (2) • A medicinal product by presentation may arise • Where the product is “indicated or recommended” for treating or preventing disease • Where the average well informed consumer gains the impression, which, provided it is definite, may even result from implication, that the product in question should, regard being had to its presentation, have the properties of treating or preventing disease • In particular the external form of the product (eg tablet, pill or capsule) may serve as strong evidence of the intention to market the product as a medicinal product (but cannot be the sole or conclusive evidence) • Not only the form of product but the form of packaging may be strong evidence of intention to market the product as a medicinal product, which may for reasons of marketing policy tend to make it resemble a medicinal product • Particular regard may be had to the form of packaging and product information which makes reference to medical endorsement of the product. • A statement that a product is NOT a medicinal product is persuasive evidence which may be taken into consideration but it is not in itself conclusive. 

  8. Medicinal product „by presentation“ (3) • Examples of ECJ rulings: • Leentert van Bennekom - ECJ 30 Nov 1983 • Vitamines in the form of tablets, pills and capsules • Legislation – seeks to preserve consumers not only from harmful oe toxic MPs but also from a variety of products used instead of the proper medicines • Concept of presentation – „has to be broadly construed“ • Jean Marie Delattre - ECJ 21 March 1991 • Products bearing a claim they are NOT MP • ECJ – form and manner of packaging similar to that of MP, then product may be regarded a MP • Commission of the European Communities v Federal Republic of Germany ECJ 15 Nov 2007 • German authorities regarded a garlic preparation in capsules as a MP • ECJ – capsule form as a sinlge indicator, is not ecxlusive to MPs • Johann Stephanis Wilhelmus Tervoort - ECJ 28 Oct 1992 • Herbal teas marketed without any indication of any therapeutic property • Product recommended or indicated as having prophylactic or therapeutic properties shall be regarded as MP, even if it is generally regarded a foodstuff and even if it has no known therapeutic effect according to the current knowledge

  9. Medicinal product „by function“ (1) • Case C-140/07, Hecht-Pharma GmbH v Staatliches Gewerbeaufsichtsamt Lüneburg of 15 January 2009 • In its answer to the first question the ECJ considered that Directive 2001/83/EC is limited to industrially-produced medicinal products and excludes products not covered by the definitions of medicinal product as laid down in Article 1(2) of said Directive. The ‘rule of doubt’ provided for in Article 2(2) of Directive 2001/83/EC applies only to products which satisfy the conditions for classification as a medicinal product. • The ECJ also observed that the definition of medicinal product by function seeks to cover products with scientifically observable pharmacological properties which are ‘genuinely designed to (…) restore, correct or modify physiological functions’. Hence, a product of which it cannot be scientifically established that it can restore, correct or modify physiological functions by means of pharmacological, immunological or metabolic action cannot be considered a medicinal product by function. • Nevertheless the ECJ considered that this does not rule out the possibility of differences of interpretation and classification of products between the different Member States. Consequently, it is possible that a product is classified as a food supplement in one Member State, whereas it is considered a medicinal product in another.

  10. Medicinal product „by function“ (2) • But if all characteristics of a product should be taken into account for the classification of medicinal product by function, how should the ‘physiological effect’ of a product then be evaluated? Should a product be classified as a medicinal product by function even if it is incapable of restoring, correcting or modifying physiological functions on the basis of its composition and use according to indicated dose, or are the requirements more stringent? According to the ECJ: “(…) products containing a substance having a physiological effect cannot automatically be classified as medicinal products by function (…)”. Every product should be carefully examined on an individual basis by the competent authority. This authority should particularly assess the precise pharmacological, immunological or metabolic characteristics of the product in so far as these can be established by current scientific knowledge. But even if such effects are acknowledged for a substance, this does not necessarily lead to the conclusion that a product containing that substance is medicinal by function. The mere fact that pharmacological, immunological or metabolic characteristics can be established should in the words of the ECJ: ‘not lead to the classification as medicinal products by function of products which, while having an effect on the human body, do not significantly affect the metabolism and thus do not strictly modify the way in which it functions’. • Therefore, a product used in line with the prescribed dose is not a medicinal product by function, if according to its composition, it is unable to appreciably restore, correct or modify the physiological functions

  11. Medicinal product – example of a national court judgement • Recent example of the national court judgment for a veterinary medicinal product • Teat sealant • http://www.courtsni.gov.uk/NR/rdonlyres/53C4194D-58BC-44D6-9AE3-7E7369F22609/0/j_j_WEA7789Final.htm

  12. Medicinal products for veterinary use Bordeline products Biocidal products Feedingstuffs / feed additives Other „out of scope“ products Veterinary autogeneous vaccines Blood, blood products „New therapies“ Medicated feedingstuffs Veterinary devices In vitro diagnostics

  13. Role of NCAs • Regulation • Science • Contribution to the socio-economic development

  14. Acquis Communautaire EU institutions International agreements National policies Bilateral 3rd countries agreements National legislation National institutions

  15. Role of NCAs • Animal health / welfare – Public heath –Environment • Compliance with Acquis Communautaire • Single market • EU activities • Equal conditions • International harmonisation • Availability of VMPs • National policies

  16. Main tasks NCAs • Marketing Authorisation / Post-authorisation Management of Veterinary Medicinal Products • Inspection activities • Pharmacovigilance • Advertisement of VMPs • Activitiesat the EU level • Use of VMPs (incl. „cascade“ and records) • Supervision / sanctions • Improving availability of VMPs • National policies / activities

  17. Marketing authorisation – general requirements • Benefit : risk assessment • Scientific capacity (! qualified staff) • Legislation • „hard law“ • „soft law“ • Co-operation at the EU level • Common understanding • Mutual trust • Training • Regulatory / administrative efficiency • Legislation • Co-operation / Co-ordination at the EU level • Specific national requirements • Timelines • E-submissions • Compliance with the Acquis Communautaire

  18. Marketing authorisation of VMPs • National procedure • Mutual recognition procedure / Decentralised procedure • Centralised procedure • Bordeline products • „MAY“ provisions

  19. National procedure (1) • Limited number of products in the EU environment • Same requirements as for the other types of procedures while market limited to a single MS • Directive 2001/82/EC as amended • „Old products“ • Compliance with Acquis • New applications vs. Old products • Accession experience: • Pre-accession update • Legal basis • Updated dossier

  20. National procedure (2) • Currently the way for MU/MS – limited market products • Products „tailored“ to specific needs of respective Member States • Fish, bees, game, small ruminants

  21. Marketing authorisation of VMPs • National procedure • Mutual recognition procedure / Decentralised procedure • Centralised procedure • Bordeline products • „MAY“ provisions

  22. Mutual recognition / Decentralised procedure (1) • Accession experience – MRP (DCP) means a true EU perspective in the licensing system • Legislation / guidelines / best practice guides • Formal Co-ordination group – CMDv (Dir. 2001/82/EC) • Organisation / Co-operation / Communication • NCAs • Industry (applicants) • Timelines • IT tools (CTS) • Language

  23. Mutual recognition / Decentralised procedure (2) • Resources • Scietific capacity of the NCAs – Benefit : risk justification – challeging the RMS AR • „potential serious risk“ • http://ec.europa.eu/health/files/eudralex/vol-6/newdoc/2006_c_132_08_en.pdf • Mutual trust • Agreement / referrals • Harmonised SPCs • Availability of medicines • General contribution to an EU harmonised views in the area of VMP regulation • Identification of outstanding issues

  24. Mutual recognition / Decentralised procedure (3) • NCA acting as Concerned Member State (CMS) • AR from the RMS • Product literature in the dossier (applicant) • Critique of the RMA AR with reference to the information submitted in the dossier • LoQ • Agreement x Referral procedure • Mutual trust - Priorisation of assessment

  25. Mutual recognition / Decentralised procedure (4) • NCA acting as Reference Member State (RMS) • Leading authority • Scientific assessment • Procedure Co-ordination • Assessment report • Quality – clear with respect to benefit : risk conclusions / LoQ • Conclusions • Post-authorisation management • Variations • Renewals

  26. Mutual recognition / Decentralised procedure (5) • Currently – MRP/DCP used mainly for authorisation of generics to the well established products • E.g. tiamulin, doxycycline, amoxycilin / clavulanic acid, enrofloxacin, flunixin • Pre-accession experience • Observeship to VMRFG • Elaboration of a procedure for applicants and candidate Member States (C-CMS) • Authorisation of VMPs under this procedure before the accession • Administrative repeat use after the accession for full integration of the products under MRP

  27. Marketing authorisation of VMPs • National procedure • Mutual recognition procedure / Decentralised procedure • Centralised procedure • Bordeline products • „MAY“ provisions

  28. Centralised procedure (1) • Applications submitted to the European Medicines Agency (EMA – formerly EMEA) • EMA • http://www.ema.europa.eu/ema/index.jsp?curl=/pages/home/Home_Page.jsp&jsenabled=true) • Secretariat • Scientific committee • Committe for Veterinary Medicinal products (CVMP) • Scientific opinion • European Commission (DG SANCO) • http://ec.europa.eu/health/index_en.htm • Decision

  29. Centralised procedure (2) • Products liable to the CP • Obligatory • Products specified in the Annex to the Reg. 726/2004 • Optional • VMP containing new APIs not authorised in the Community on the date of entry into force of the Regulation • Product constituting significant therapeutic, scientific or technical innovation • Immunological VMP for the treatment of animal diseases subject to Community prophylactic measures

  30. Centralised procedure (3) • Role and tasks of the NCAs in the CP • Usually – nomination of a member of the Scientific Committee • Member of a scientific committee • Time needed for preparation of the committee meetings (monthly) •  3 – 5 working days needed • Sufficient expertise / network of experts available to the CVMP member • Rapporteur / Co-rapporteur / peer-reviewer

  31. Centralised procedure (4) • !! Rules for experts apply – under revision • Expertise • Conflict of interests • Comments from Member States • Check of product literature for CP • QRD group • Standing Committee membership (European Commission) • Consultion procedure • Meetings if needed (approx. 1 / year) • Supervison and sanctions

  32. Marketing authorisation of VMPs • National procedure • Mutual recognition procedure / Decentralised procedure • Centralised procedure • Bordeline products • „MAY“ provisions

  33. Bordeline products (1) • Definition of a medicinal product (vide supra) • Article 2, par. 2 of Dir. 2001/82/EC • In cases of doubt, where taking into account all its characteristics, a product may fall within the definition of a "veterinary medicinal product" and within the definition of a product covered by other Community legislation, the provisions of this Directive shall apply • Number of products – clear categorisation difficult • Presentation, claims, intended use, dosage form, packaging ......

  34. Bordeline products (2) • Czech Republic – non-harmonised category of veterinary non-medicinal products under the veteinary act • In-vitro diagnostics • Diagnosis of infectious agents • Food-borne diseases • Disinfectans • External treatment of intact skin or externally accesible mucosae • Minor skin injuries, operation field, disinfection of udder • Dietetics • Vitamin / mineral products • Cosmetic products

  35. Bordeline products (3) • Still different approach in different Member States • formation of a „bordeline products“ subgroup under the CMDv

  36. Marketing authorisation of VMPs • National procedure • Mutual recognition procedure / Decentralised procedure • Centralised procedure • Bordeline products • „MAY“ provisions

  37. „MAY“ provisions (1) • „MAY“ provisions – may be implemented if deemed necessary by the Member States for implementation of the national policies – examples • Possibility to exclude life autogenous vaccinnes from the scope of directive (Art. 4) • Possibility to exempt certain products for aquarium fish, cage birds, homing pigeons, terrarium animals, small rodents, and ferrets and rabbits kept exclusively as pets from the authorisation (Art. 4) • Authorisation of marketing of products for which a MA has been granted by another Member States, where health situation so requires (Art. 7)

  38. „MAY“ provisions (2) • Provisional use of immunological products without MA in case of serious epizootic diseases (Art. 8) • Use of immunological VMPs authorised in the 3rd country for animals imported/exported to/from the 3rd country (Art. 8) • Specific rules for safety and pre-clinical and clinical trials of homeopathic VMPs • „Blue box“ information to be indicated at the outer packagings of veterinary medicinal products authorised under 726/2004 (Art. 58) • Exemption of labels / package leaflets for specific VMPs to be in the official language of a Member State (Art. 61)

  39. „MAY“ provisions (3) • Prohibition of the manufacture, import, possession, sale, supply and/or use of immunological veterinary medicinal products on the whole or part of its territory under specific circumstances (Art. 71) • Pharmacovigilance reporting – specific requirements on veterinary practitioners and other health professionals (Art.72) • Susension of product due to pharmacovigilance (Art. 78) • OCABR / OBPR for veterinary immunologicals (Art. 81, 82)

  40. Activities at the EU level • EC • Veterinary Pharmaceutical Committee • Standing Committee for Veterinary Medicinal Products • Notice to Applicants • Legislation • Other (WHO / Codex, AMR ....) • EMA • CVMP Working parties • Guidelines • Advisory groups • Contribution to international activities • VICH • Codex • 3Rs

  41. Activities at the EU level • HMA • http://www.hma.eu/ • Policies / strategies • Optimisation of the regulatory network function • Co-ordination of activities / co-operation • PSUR worksharing • Antiicrobial resistance issues (AMR) • Availability of veterinary medicinal products • Contribution to the development of the EU regulatory environment • Task force – veterinary legislation

  42. National policies / activities (1) • Areas conferred on the Member State in accordance with the EU law • subsidiarity principle • „May“ provisions • Use of VMPs • Prescription habits

  43. National policies / activities (2) • Immunologicals • Veterinary autogenous vaccines • Availability – MU/MS • Clinical trials • Antimicrobial resistance • Novel therapies • Cells, tissues

  44. National policies / activities (3) • Legal categories of VMPs • Distribution / retail channels • Fees • Other scientific activities

  45. Thank you for your attention ! bures@uskvbl.cz

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