Marketing authorization procedures in eu

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Marketing authorization procedures in eu

  1. 1. MARKETING AUTHORIZATION PROCEDURES IN EU A. RAJANI
  2. 2. Types Of MA Procedures <ul><li>Roads to enter EU </li></ul><ul><li>National </li></ul><ul><li>Centralized </li></ul><ul><li>Mutual Recognition </li></ul><ul><li>De-centralized </li></ul>
  3. 3. Types Of MA Procedures <ul><li>What happens once the pharmaceutical company has submitted its application for a marketing authorisation? </li></ul><ul><li>Full copies of the marketing authorisation application file are sent to a rapporteur and a co-rapporteur designated by the competent EMEA scientific committee. They co-ordinate the EMEA's assessment of the medicinal product and prepare draft reports. </li></ul><ul><li>Once the draft reports are prepared (other experts might be called upon for this purpose), they are sent to the CHMP or CVMP, whose comments or objections are communicated to the applicant. The rapporteur is therefore the privileged interlocutor of the applicant and continues to play this role, even after the marketing authorisation has been granted. </li></ul><ul><li>The rapporteur and co-rapporteur then assess the applicant's replies, submit them for discussion to the CHMP or CVMP and, taking into account the conclusions of this debate, prepare a final assessment report. Once the evaluation is completed, the CHMP gives a favourable or unfavourable opinion as to whether to grant the authorisation. When the opinion is favourable, it shall include the draft summary of the product's characteristics, the package leaflet and the texts proposed for the various packaging materials. </li></ul><ul><li>The time limit for the evaluation procedure is 210 days (the application formalities and the detailed procedure are described in the Notice to Applicants which is available in the Eudralex volumes). </li></ul><ul><li>The Agency then has thirty days to forward its opinion to the Commission. This is the start of the second phase of the procedure: the decision-making process. The Agency sends to the Commission its opinion and assessment report, together with annexes containing: </li></ul><ul><li>the summary of product characteristics (Annex 1); </li></ul><ul><li>the particulars of the manufacturing authorisation holder responsible for batch release, the particulars of and the manufacturer of the biological active substance and the conditions of the marketing authorisation (Annex 2); </li></ul><ul><li>the labelling and the package leaflet (Annex 3). </li></ul>
  4. 4. Types Of MA Procedures <ul><li>The annexes are translated into the 21 Community languages. </li></ul><ul><li>During the decision-making process, the Commission services verify that the marketing authorisation complies with Community law and turn the Agency's opinion into a binding decision for all the Member States. </li></ul><ul><li>The Commission has thirty days to prepare a draft decision. The medicinal product is assigned a Community registration number, which will be placed on its packaging if the marketing authorisation is granted. During this period, various Commission directorates-general are consulted on the draft marketing authorisation decision. They have ten days to deliver their opinions. </li></ul><ul><li>The draft decision is then sent to the Standing Committee on Medicinal Products for Human Use, or the Standing Committee on Veterinary Medicinal Products (Member States have one representative each in both of these committees) for their opinions. The Rules of Procedure of these Committees are here [22 KB] . </li></ul><ul><li>Member States have fifteen days to return their linguistic comments and 22 days for scientific and technical ones. This procedure is conducted in writing but if a duly justified objection is raised by one or more Member States, the committee holds a plenary meeting to discuss it. </li></ul><ul><li>When the opinion is favourable, the draft decision is forwarded to the Commission's Secretariat-General for adoption through an empowerment procedure , enabling the Commissioner for Enterprise and Industry to issue the final decision. </li></ul><ul><li>When the decision is approved, the Commission's Secretariat-General notifies the Member States and the marketing authorisation holder in their respective languages. The decision is then published in the Official Journal of the European Communities. </li></ul><ul><li>Marketing authorisations are valid for five years. Applications for renewal must be made to the EMEA at least six months before this five-year period expires. </li></ul>
  5. 5. National Procedure <ul><li>Marketing Authorization in one Member State only </li></ul><ul><li>Abridged Application to nationally authorised originators /innovators </li></ul><ul><li>Time-line : 210 days </li></ul>
  6. 6. Centralized Procedure ( CP ) <ul><li>An approval in all EU countries obtained by applying to the EMEA (European Medicines Evaluation Agency) . </li></ul><ul><li>Mandatory for Biogenerics -if biotechnological products </li></ul><ul><li>Generics –New Entrants </li></ul><ul><li>Optional for Generics </li></ul><ul><li>Review Time : 210 days </li></ul>
  7. 7. Centralized Procedure ( CP ) <ul><li>The centralised procedure , which is compulsory for products derived from biotechnology, for orphan medicinal products and for medicinal products for human use which contain an active substance authorised in the Community after 20 May 2004 (date of entry into force of Regulation (EC) No 726/2004) and which are intended for the treatment of AIDS, cancer, neurodegenerative disorders or diabetes. The centralised procedure is also mandatory for veterinary medicinal products intended primarily for use as performance enhancers in order to promote growth or to increase yields from treated animals. Applications for the centralised procedure are made directly to the European Medicines Agency (EMEA) and lead to the granting of a European marketing authorisation by the Commission which is binding in all Member States. </li></ul>
  8. 8. Centralized Procedure ( CP ) <ul><li>The centralised procedure, which came into operation in 1995, allows applicants to obtain a marketing authorisation that is valid throughout the EU. It is compulsory for medicinal products manufactured using biotechnological processes, for orphan medicinal products and for human products containing a new active substance which was not authorised in the Community before 20 May 2004 (date of entry into force of Regulation (EC) No 726/2004) and which are intended for the treatment of AIDS, cancer, neurodegenerative disorder or diabetes. The centralised procedure is also mandatory for veterinary medicinal products intended primarily for use as performance enhancers in order to promote growth of treated animals or to increase yields from treated animals. </li></ul><ul><li>The centralised procedure is optional for any other products containing new active substances not authorised in the Community before 20 May 2004 or for products which constitute a significant therapeutic, scientific or technical innovation or for which a Community authorisation is in the interests of patients or animal health at Community level. </li></ul><ul><li>When a company wishes to place on the market a medicinal product that is eligible for the centralised procedure, it sends an application directly to the European Medicines Agency, to be assessed by the Committee for Medicinal Products for Human Use (CHMP) or the Committee for Medicinal Products for Veterinary Use (CVMP) . </li></ul><ul><li>The procedure results in a Commission decision, which is binding on all EU Member States, to authorise the product. Centrally-authorised products may be marketed in all Member States. </li></ul><ul><li>Applications from persons or companies seeking 'orphan medicinal product designation' for products they intend to develop for the diagnosis, prevention or treatment of life-threatening or very serious conditions that affect not more than 5 in 10,000 persons in the European Union are reviewed by the Committee for Orphan Medicinal Products (COMP) . </li></ul><ul><li>The Committee on Herbal Medicinal Products (HMPC) is responsible for establishing a list of herbal substances, preparations and combinations thereof for use in traditional herbal medicinal products. It is also responsible for establishing Community herbal monographs. </li></ul>
  9. 9. Mutual Recognition Procedure (MRP) <ul><li>Used for > 1 Countries </li></ul><ul><li>Generic Industry : Major user of MRP </li></ul><ul><li>1 St Step: Submission to one national authority - Reference Member State –RMS - for review. </li></ul><ul><li>If successful :RMS assessment report => used in all EU countries - Concerned Member States –CMS </li></ul><ul><li>Review Time : 210 + 90 +90 days </li></ul>
  10. 10. Mutual Recognition Procedure (MRP) <ul><li>The mutual recognition procedure , which is applicable to the majority of conventional medicinal products, is based on the principle of recognition of an already existing national marketing authorisation by one or more Member States. </li></ul>
  11. 11. Mutual Recognition Procedure (MRP) <ul><li>The mutual recognition procedure is based on the principle of the mutual recognition by EU Member States of their respective national marketing authorisations. An application for mutual recognition may be addressed to one or more Member States. The applications submitted must be identical and all Member States must be notified of them. As soon as one Member State decides to evaluate the medicinal product (at which point it becomes the &quot;Reference Member State&quot;), it notifies this decision to other Member States (which then become the &quot;Concerned Member States&quot;), to whom applications have also been submitted. Concerned Member States will then suspend their own evaluations, and await the Reference Member State's decision on the product. </li></ul><ul><li>This evaluation procedure undertaken by the Reference Member State may take up to 210 days, and ends with the granting of a marketing authorisation in that Member State . It can also occur that a marketing authorisation had already been granted by the Reference Member State. In such a case, it shall update the existing assessment report in 90 days. As soon as the assessment is completed, copies of this report are sent to all Member States, together with the approved summary of product characteristics (SPC), labelling and package leaflet. The Concerned Member States then have 90 days to recognise the decision of the Reference Member State and the SPC, labelling and package leaflet as approved by it. National marketing authorisations shall be granted within 30 days after acknowledgement of the agreement. </li></ul><ul><li>Should any Member State refuse to recognise the original national authorisation, on the grounds of potential serious risk to public health, the issue will be referred to the coordination group. Within a timeframe of 60 days, Member States shall, within the coordination group, make all efforts to reach a consensus. In case this fails, the procedure is submitted to the appropriate EMEA scientific committee (CHMP or CVMP, as appropriate), for arbitration. The opinion of the EMEA Committee is then forwarded to the Commission, for the start of the decision making process. As in the centralised procedure, this process entails consulting various Commission Directorates General and the Standing Committee on Human Medicinal Products or the Standing Committee on Veterinary Medicinal Products, as appropriate. The Rules of Procedure of these Committees are here [22 KB] . </li></ul>
  12. 12. Decentralized Procedure (DCP) <ul><li>Used for > 1 Countries </li></ul><ul><li>Generic Industry :will be major user of DCP </li></ul><ul><li>Used for products that have not yet received authorisation in an EU country. </li></ul><ul><li>RMS & CMS receives MAA at the same time </li></ul><ul><li>RMS & CMS also grants MA at the same time </li></ul><ul><li>Time : 210 days. </li></ul>
  13. 13. Decentralized Procedure (DCP) <ul><li>The decentralised procedure , which was introduced with the legislative review of 2004, is also applicable to the majority of conventional medicinal products. Through this procedure an application for the marketing authorisation of a medicinal product is submitted simultaneously in several Member States, one of them being chosen as the &quot;Reference Member State&quot;. At the end of the procedure national marketing authorisations are granted in the reference and in the concerned Member States. </li></ul>
  14. 14. Decentralized Procedure (DCP) <ul><li>The decentralised procedure was introduced by Directive 2004/27/EC . As the mutual recognition procedure, it is also based on recognition by national authorities of a first assessment performed by one Member State . The difference lies in that it applies to medicinal products which have not received a marketing authorisation at the time of application. </li></ul><ul><li>How does the decentralised procedure work? </li></ul><ul><li>An identical application for marketing authorisation is submitted simultaneously to the competent authorities of the Reference Member State and of the Concerned Member States. At the end of the procedure, the draft assessment report, SPC, labelling and package leaflet, as proposed by the Reference Member State, are approved. </li></ul><ul><li>The subsequent steps are identical to the mutual recognition procedure . </li></ul>
  15. 15. MARKETING AUTHORIZATION PROCEDURES IN EU

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