Rapporteur member state

The notification procedure of existing active substances, which had started in 2000, was finalized on 31 January 2003. After having succeeded the notification procedure, the names of existing active substances have been published in the Official Journal of the European Communities (OJ). At the next step, the full dossier including aU test reports should be submitted to the Rapporteur Member State in agreed Data Formats including the risk assessment of the active substance. At the last step, the Rapporteur Member State in cooperation with all other Member States will decide whether the active substance wUl be entered onto the positive lists or not. 

When proposing an MRL, the Rapporteur Member State (RMS) identifies the Acceptable Daily Intake (ADI) and Acute Reference Dose (ARfD) for man that is valid for the pesticide in question. The ADI thus identified is often the same as that recommended by the Joint FAO/WHO Meetings on Pesticide Residues (JMPR), whose recommendations on ADIs and MRLs are used within the Codex Alimentarius system. If the ADI proposed by the RMS is not that recommended by JMPR, the RMS has to provide an explanation for the difference. The other Member States comment on the RMS proposal at meetings of the Working Group on Pesticide Residues. If the Member States cannot reach agreement on the evaluation, the matter is referred to one or more of the Commission s scientific advisory committees. Prior to autumn 1997, such questions were referred to the Scientific Committee for Pesticides, but since then they have been referred to the Scientific Committee on Plants. 

Applications from industry are submitted to the EMEA. Since a large number of substances have to be dealt with, the workload is spread by appointing each Member State represented in the CVMP as rapporteur or co-rapporteur for a number of specified veterinary drugs. Using the information in the dossier provided by the manufacturer, the Rapporteur Member State (RMS) proposes an ADI for the drug in question and MRLs for relevant foodstuffs of animal... 

After examining dossiers supplied by industry, Rapporteur Member States in the CVMP s Safety Working Party (SWP-V) propose ADIs and MRLs for substances authorised before 1 January 1992. These proposals are then discussed by the CVMP. When the CVMP has reached agreement on MRLs, they are then adopted by the procedure described above for New substances . 

Each review is to be undertaken by a pre-specified Member State. The third published Regulation lists the Rapporteur Member States for the substances included in the first two batches. A further regulation will be published to identify the Rapporteur Member States for the substances in the third and fourth batches. 

It is important to understand the impact these compounds can have on human health because of the potential for exposure to the general public. The toxicology of MTBE and ETBE has been reviewed previously [2-6]. ETBE is currently also under review for risk assessment by the European Union (rapporteur Member State, Finland). Since the structures of ETBE and MTBE are very similar, it is expected that there will also be similarities in their toxicological properties. Sometimes, this may allow gaps in the database for ETBE, which has been less extensively studied, to be tentatively supplemented with data derived from studies with MTBE. 

Annex V specifies the Rapporteur Member States responsible to review the accepted notified substances. The notified substances in respect to wood preservatives and rodenticides (product-types 8 and 14) and to mol-luscicides, insecticides, repellants and attractants and antifouling products (product-types 16, 18, 19 and 21) are designated to Rapporteur Member States who are responsible of the evaluation of the dossiers. 

Complete dossiers for product-types 16, 18, 19 and 21 must be received by the competent authority of the Rapporteur Member State no earlier than November 1, 2005 and no later than 30 April 2006. 

European Food Safety Authority peer review of active substances European Food Safety Authority (EFSA), Parma http //www.efsa.europa.eu/en/efsajournal and Summary dossiers and rapporteur Member State assessment reports. European Food Safety Authority (EFSA), Parma, http //www.efsa.europa.eu/en/pesticide-... 

The decentralised procedure can be used in cases where the product has never been authorised in any of the Member States, and the applicant wishes to obtain a license in a number of states simultaneously. The applicant must submit applications with the complete dossier to the Competent Authorities of each of the Member States where authorisation is desired. A single Member State should be chosen as the reference state to undertake the scientific assessment ofthe complete dossier, while the other states are designated as concerned states. The review process has many parallels vhth the centralised procedure, in that similar time lines exist, the reference State plays the role ofthe rapporteur, and the concerned States replace the CHMP. Once all States have validated that the dossiers are complete, the reference State is allowed 70 days to review the dossier and prepare a preliminary assessment report, which is circulated to the concerned Member States and the applicant. Comments from the concerned Member States and applicant responses are collected so that by day 120 the reference State may issue a draft assessment report together vhth draft SPC, label and leaflet texts. The clock may be stopped until requested responses from the applicant are received. The application then enters the second step in the assessment process, during which all the concerned Member States consider the... 

The first draft of the risk assessment reports are written by the Member States, which act as rapporteurs . Generally, one Member State acts as rapporteur for a prioritized substance or group of substances however, for some prioritized substances, more than one Member State can act as rapporteurs. The risk assessment process is coordinated by the ECB. Stakeholders are involved in the process through the Technical Committee for New and Existing Substances (TC NES). The Commission mediates the meetings, which attempt to reach consensus on the conclusions of the risk assessments. During the risk assessment process, the Scientific Committee on Health and Environmental Risks (SCHER) is requested to provide an opinion. 

On receipt of a valid application via the EMEA, the rapporteur and the co-rapporteur both prepare their separate detailed assessment reports, which are circulated to the EMEA and all other Member States by day 70 from the start of the procedure. The new Regulation requires that the duration of the analysis of the scientific data in the file concerning the application for marketing authorisation must be at least 80 days, except in cases where the rapporteur and co-rapporteur declare that they have completed their assessment before that time. 

This guideline lays down the roles and responsibilities of the MAH and of the national competent authorities in respect of the products authorised through the national procedures (including the mutual recognition procedure). Also defined are the roles and responsibilities of the Reference Member States (for mutual recognition products) and of the rapporteur and EMEA for centrally approved products. The role and responsibilities of the MAH include having a named, qualified person responsible for pharmacovigilance at the EU level, and there may be a need for an additional named person at the national level when this is required. 

The responsibility for carrying out the Risk Assessment of a particular substance is entrusted to an individual EU Member State, known as a rapporteur.40 The rapporteur is responsible for gathering relevant information and for making recommendations to the European Commission on any... 

Centralized Procedure (CP) This is the procedure of most interest for biopharmaceuticals, as this is the mandatory route for review and approval of such drugs in the European Union. In the centralized procedure a single application is submitted to the European Medicines Agency (EMEA). A variety of presubmission activities, starting six months before the intended start date of the centralized procedure, are required [8], Two initial assessments by a Rapporteur and Co-rapporteur national authorities (one from each of two member states chosen by the EMEA) are made, leading to Day 80 Critical Assessment Reports. A consolidated list of questions (LoQ) is provided to the applicant at Day 120 when there is a clock stop, normally of three months, to allow the preparation and submission of responses. Following satisfactory negotiation of other steps in the procedure, the Committee on Human Medicinal Products will recommend authorization at Day 210, with authorization by the Commission at Day 277. 

The primary task of SCHER is to review Risk Assessment Reports established according to the regulation on evaluation and control of risks of existing substances (EEC 1993). These reports evaluate the risks of prioritised substances, and they are drafted by member state rapporteurs and decided on through comitology procedures. The job of SCHER is to review the scientific quality of these reports, particularly with regard to how they specify risks to public health, consumers and the environment. The committee put together its review in an opinion , which basically clarifies what it considers to be the health and environmental risks of the substance under study. Opinions also discuss the level and conditions of scientific uncertainty as well as whether and, if so, what further research is called for. The Commission may also ask SCHER for advice on other specific issues, even if there is no RAR to review. 

Based upon a market authorization in one member state, applications of the same dossier are lodged with the authorities of other member states. The second country s abbreviated evaluation will be mainly based upon the assessment report by the flrst authority and on the expert reports on the main sections of the dossier. If the applicant choses to make parallel applications in several member states, rather than waiting for approval in the first country, one country will be appointed as rapporteur. The other countries await the assessment... 

In the future, a centralized registration will be handled by the new European Agency. The CPMP and rapporteurs, drawn from the national authorities, will evaluate the application and provide an opinion, which is either accepted by the individual member states or referred to a Committee of the EC Commission for a final, binding decision. 

A similar system, the "concertation procedure" is already in place and is obligatory for products from biotechnological processes. The CPMP becomes involved as soon as the first application in any member state is lodged. One country s agency acts as rapporteur and prepares a full evaluation report, other countries provide "monitoring reports". Based on these reports and the expert reports in the dossier, the CPMP summarizes its assessment in an opinion report which is considered by the national authorities, before they make their decision. 

The centralised procedure allows applications to be made directly to the EMEA, which are then allocated for assessment to one member state (the rapporteur) assisted by a second member state (co-rapporteur). This approach is mandatory for biotechnology products and optional for new medicinal products. 

In January 1995, Directive 75/319 of the Council of the European Communities came into force. The regulation introduced new procedures whereby a European MA may be obtained. The net effect of this has been to move work from a national to a European basis, particularly for novel chemicals. The IMB is active in both the centralized and decentralized (mutual recognition) licensing processes, having acted in the centralised process as rapporteur or co-rapporteur on 12 occasions, and having been Reference Member State (RMS) in approximately 10 decentralized applications. 

In the Centralised Procedure a Rapporteur and a Co-Rapporteur, appointed from within the member states of EU, have to evaluate the product and report to the European Medicines Agency within 210 days. If the UK is selected as Rapporteur or Co-Rapporteur, the evaluation of the medicinal product is carried out by the MHRA. Occasionally, when there is particular interest in a novel medicinal product, or when a new medicinal product would have a significant affect on drug usage in the NHS, the MHRA will get involved and opinions will be sought from scientific advisory committees. A recent example of this was when the first inhaled formulation of human insulin was licensed. 

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