European licensing procedures

Since the first European Directive on medicinal products was published in 1965, a lot of work has been done to harmonise the authorisation of medicinal products across the European Union (EU). At the time of writing (early 2007) the most recent legislation is Directive 2001/83 implemented in October 2005. 

There are essentially two types of European licensing procedures  

The Centralised Procedure results in a single application, a single evaluation and a single authorisation in all member states of the EU and generates a European marketing number for the product. 

The Centralised Procedure is mandatory for certain categories of product such as 

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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In conclusion, a procedure makes it possible to avoid duplication of work not only by manufacturers of raw materials and manufacturers of medicines (finished products) when they prepare licensing dossiers but also by the licensing authorities and pharmacopeia authorities when they assess these dossiers. Differences among the various European licensing authorities in approach and assessment of compliance with European Pharmacopeia monographs are also avoided, and clearer communications are facilitated. Finally, the procedure allows European Pharmacopeia monographs to be constantly updated to keep up with new developments in the world market. 

The institution of the new European licensing systems (centralised and de-centralilsed) in 1995 hcis brought about the most profound change in European pharmaceutical regulation since its inception. The scientific skills and the standards applied have undoubtedly risen, the leveling-off effect hcis been upwards rather than downwards. This is most evident in the new systems where the assessment reports are freely available, but it is edso likely to have affected the national procedures. Skills learned in the centralised procedure will also be applied to national applications. 

A concept of an evolutionary reactor is pursued with the joint French / German European Pressurized Water Reactor , EPR, a 1525 MW(e) plant with evolutionary steam generating system and innovative double-walled containment [20]. A three years basic design phase as a prerequisite for the beginning of the licensing procedure was finished in 1997. The characteristic feature is a core catcher to restrict a possible core melt to the power plant itself. The joint effort by Germany ind France, however, finds in both countries a situation where no further base load is required. The EPR, confirmed as a future standard in France, is projected to substitute decommissioned nuclear plants. 

In continuation of the basic design work, in January 1995 the European Commission ordered a follow-up study on preparation of the licensing procedure for the SURF plant with the following main objectives [3] ... 

Eurther to this directive, the European Medicines Agency (EMEA) began, in 2001 [98], to outline a feasible risk assessment scheme, which was later published in a draft form in 2003 [50] in 2006 [51], the following five-step procedure was adopted, with a view to guaranteeing that possible long-term and low-level effects of the new substances are not overlooked this procedure is also used in the licensing of new compounds (including pharmaceuticals). 

The certification procedure is a complement and bridge between the public standards described in the European Pharmacopeia and the need to prepare a file for licensing. This procedure is a result of much common discussion and agreement among the partners concerned. It was in fact made to measure its collaboration not only with the European regulatory authorities so that they could rely on it totally and recognize unreservedly its validity but also with the industries so that they could be absolutely sure of the protection of industrial property. 

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. 

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. 

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