Marketing authorisations national procedure

Evaluation of applications for drug marketing authorisations made either directly to the national authority or indirectly via the centralised procedure to the EMEA... 

The procedures and timelines for obtaining marketing authorisations for veterinary products are essentially the same as those for human medicines. Extensive guidance can be found in The Rules Governing Medicinal Products in the European Union, Volume 6 - Notice to Applicants, Veterinary Medicinal Products. The products that may follow centralised procedures and receive Community authorisations are shown in Eigure 7.5. All other products must obtain authorisations from national... 

EC) No. 1085/2003 outline the procedures for processing variations to marketing authorisations granted via National and Community procedures, respectively. The Annexes to the regulations provide criteria for categorisation of changes. 

Marketing authorisations in the European community can be obtained at present by two main procedures - mutual recognition of a national authorisation from one Member State or a community-wide authorisation through a procedure known as the centralised procedure. In November 2005, a new procedure, known as the decentralised procedure, will be introduced under the new legislation. 

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. 

Central to the decision to grant a marketing authorisation is the assessment procedure undertaken by professional medical, scientific, statistical and pharmaceutical staff at one of the national agencies. In the UK these are employed as dvil servants within the MCA and are advised by various independent expert committees (see above). 

As a result of Council Regulation (EEC) No. 2309/93 of July 22, 1993, which established the European Agency for the Evaluation of Medicinal Products, three types of procedures for authorising the placing of medicinal products on the market were introduced, depending on the characteristics and specific nature of the medicinal product in question centralised procedure, decentralised procedure and national procedure. 

National marketing authorisations were intended to be phased out from 1 January 1998. It was foreseen that beyond that date, all marketing authorisations within the European Union would have been issued under the rules governing medicinal products in the European Community through the Centralised Procedure, or the so-called Mutual Recognition or Decentralised Procedure (see below). However, national approvals for marketing have continued well beyond 1 January 1998. 

This directive required that products covered by Annex A of the classification had to be referred to the CPMP for an opinion before a marketing authorisation (MA) could be granted in any Member State. This process became known as the Concertation Procedure, or Centralised Procedure. Products covered by Annex B could, at the request of the manufacturer, be dealt with by the Concertation Procedure or by an individual national authority and then achieve entry into other EU Member States markets if requested by means of the multistate or mutual recognition procedure. 

Under the mutual recognition procedure, the applicant company usually ends up receiving national marketing authorisations from some or all of the national drug regulatory authorities to whom the dossier is submitted. The centralised procedure, on the other hand, is all or none , and under it the applicant company would receive a single marketing approval from the EMEA valid in all European Union countries. Rejection of an application under the centralised procedure means that the product cannot be marketed in any Member State. 

The first of these guidelines lays down the roles and responsibilities of the marketing authorisation holders and of the national competent authorities in respect of the products authorised through the national procedures (including 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. 

Compassionate use is a treatment option that allows the use of an unlicensed medicine. Compassionate use programmes are for patients in the European Union (EU) who have a disease with no satisfactory authorised therapies or cannot enter a clinical trial. They are intended to facilitate the availability to patients of new treatment options under development. To qualify for a compassionate use programme, the manufacturer calls on the national authorities for permission. The manufacturer must submit a request for the granting of a marketing authorisation or he must perform research in the context of a research programme with a cohort. Compassionate use procedures are also applicable for unlicensed medicines withdrawn from the market or for off-label use of licensed medicines. 

Where conformity assessment involves intervention of third party, that task is normally carried out by the notified body. The pressure equipment directive enables in addition the national authorities to authorise in their territory user inspectorates for the carrying out of conformity assessment procedures which relate to product verification. These inspectorates shall act exclusively on behalf of the group of which they are part. The placing on the market and putting into service of equipment which has undergone such assessment is however limited to the territory of the authorising Member State and to those Member States which have also proceeded to such authorisation. The equipment concerned shall therefore not bear the CE-marking. 

National provisions on specific materials still exist in areas where Community legislation is not adopted. The rule of mutual recognition applies to this national legislation. Any product lawfully produced and marketed in one Member State must, in principle, be admitted to the market of any other Member State. The only reason a Member State can reject a product is on the basis of protection of human health. Even under mutual recognition, national legislation may foresee that the use of a substance lawfully manufactured and/or marketed in another Member State is subject to prior authorisation provided certain requirements are fulfilled such as a simplified procedure for having the substance included on a national list. In non-harmonised areas... 

Medicines are made available as authorised medicines, pharmacy preparations, or investigational medicinal products. For many diseases active substances are available, and yet groups of neglected patients or special patient groups will not receive the medicines they need. If a patient needs a medicine, which is not on the national market, it may be imported from abroad or prepared in a pharmacy. The complicated rules, which are nationally determined, for reimbursement (in some Countries) and Iraig procedures render importation a laborious way to make medicines available for the patient To be reimbursed some Countries require that medicines are to be shown to be efficacious, appropriate and economic. 

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