The Mutual Recognition Procedure

The first of these can be used when a product is to be marketed in a single country. It can be used for any type of application except for certain types of biotechnology-based items. Having been approved in one country, in most cases an application to a second country will trigger the Mutual Recognition procedure in other concerned countries. There are certain exceptions to this, e.g., where a product has different summaries of product characteristics (SmPCs) in different countries, and these have not been subjected to a harmonization procedure. Line extensions to such products could also remain subject to national procedures. 

The mutual recognition procedure is an alternative means by which a marketing authorization may be sought. It is open to all drug types except products of biotechnology. Briefly, if this procedure is adopted by a sponsor, then the sponsor applies for a marketing licence not to the EMEA, but to a specific national regulatory authority (chosen by the sponsor). The national authority then has 210 days to assess the application. 

Mutual Recognition Procedure The Mutual Recognition Procedure is stated in Council Directive 93/39/EEC. In essence, once a drug is approved for marketing authorization by one member state, the company concerned can apply for marketing authorization in other member states through the mutual recognition procedure in place since 1998. 

Abridged National Authorization Procedure This procedure is for generics, and there is no necessity to provide preclinical or clinical results. However, evidence of bioavailability and bioequivalence and GMP manufacturing compliance has to be submitted. If the applicant has an abridged approval from a member state, the Mutual Recognition Procedure can be used. 

Describe the Mutual Recognition Procedure and the resolution of disputes between member states. 

Management of Community referrals and arbitrations arising from the mutual recognition procedure, and... 

Similarly, where there are public health concerns as a result of pharmacovigilance data, nationally authorized products or products authorized by the mutual recognition procedure may be referred rmder Articles 12 or 15 of Directive 75/319/EEC. The CPMP/CVMP gives an opinion on variation, suspension, or withdrawal of the marketing authorization in such cases. 

Conduct of Pharmacovigilance for Medicinal Products authorised through the mutual recognition procedure EMEA June 1997. 

Information on the mutual recognition procedure can be accessed from the EC website (see end of chapter). The procedure has a time frame of... 

Once a product goes through the mutual recognition procedure, all its post-approval activities are undertaken by the original RMS and go through the same procedure. 

Conceptually, this procedure for Community authorisations (also known as the centralised procedure) resembles a hybrid of the national procedure and the mutual recognition procedure, with the differences that first, the application is submitted to EMEA second, the dossier supporting the application undergoes a detailed assessment by the CHMP before approval in any Member State of the EU third, the applicant is provided with an opportunity to clarify any issues raised by any of the EU Member States fourth, the procedure naturally has an extended time frame but stUl with predetermined deadlines and finally, the applicant ends up with an approval or a refusal to market the product in all or any Member States of the EU. The centralised procedure is shown in Figure 17.2. 

This is a new procedure introduced imder Directive 2004/27/EC. In contrast to the mutual recognition procedure, the decentrahsed procedure applies to products for which the centralised procedure is not mandatory and which are not authorised in any EU Member State. It facilitates the parallel submission to both RMS and CMSs, involvement of the CMS during the national evaluation phase, and parallel granting of national marketing authorisations after the positive finalisation of the European step of the procedure. Some of the finer details of this new procedure established under the new legislation are yet to be confirmed. 

As with the mutual recognition procedure, if no agreement can be reached during the 90-day European step, the matter is referred to the Coordination Group for resolution and if stUl unresolved, the CHMP will arbitrate and deliver an opinion. Consequently, the grounds for refusal... 

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. 

Decentralized Procedure (DCP) The decentralized procedure was established as an application route in late 2005. This procedure is essentially a combination of the national and the mutual recognition procedures. The applicant chooses a reference member state to undertake the initial assessment. On completion of the RMS assessment, the concerned member states can put forward additional questions to those raised by the reference member state. If the questions are answered by the applicant to the satisfaction of the reference member state and concerned member states, the drug can be authorized. The benefit of the decentralized procedure is that all concerned member states are provided with the application dossier from the start of the procedure. 

Simultaneously, Directive 93/39/EEC amended Directives 65/65/EEC, 75/318/EEC,Pl and 75/319/ EEC and established the Decentralized Procedure (commonly known as the Mutual Recognition Procedure). 

Under the mutual recognition procedure, the applicant company would receive a number of national MAs from national drug regulatory authorities. Under the centralized procedure, the applicant company would receive a single marketing approval from the EMEA, valid in all EU countries. 

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