European marketing authorisation application

It is worthwhile to note that, in the US, where the applicant will just be dealing with a single authority, there is no need to re-submit data that was previously submitted as part of an IN D application to conduct clinical trials. Instead, the applicant can cross-reference the IND file. This does not apply in Europe, because clinical trial applications will have been submitted to individual Competent Authorities, whereas marketing authorisation applications are usually submitted either centrally to the European Medicines Agency (EMEA) or collectively to a number of Competent Authorities. Thus, the files need to be self-supporting. 

Recently, similar legislation has been introduced in the European Union under regulations EC/1901/2006 and EC1902/2006. This requires that marketing authorisation applications for new drugs submitted after the 28 July 2008 must be accompanied by either the results of specific studies demonstrating safety and... 

The full revised text of the Notice to Applicants Volume 2B has been available since June 2001. The revised provisions, which take into account the ICH agreements, are ultimately intended to replace the previous structure of the European marketing authorisation dossier described in the 1998 edition of Volume 2B. However, in order to take into account the fact that the marketing authorisation holders may need some time to adapt their current procedures, it has been agreed that both the previous 1998 edition of Volume 2B and the new edition published in June 2001 will coexist for some time. Therefore, from 1 July 2001 the legal requirements governing the particulars and documents to accompany an application for marketing authorisation may be fulfilled by reference to either the 2001 edition or to the previous 1998 edition of Volume 2B (EudraLex Vol 2B). 

Directive 2001/20/EC of the European Parliament and of the Council of 4 April 2001, on the approximation of the laws, regulations and administrative provisions of the member states, relates to the implementation of GCP in the conduct of clinical trials on medicinal products for human use. The commimity code relating to medicinal products for human use (2001/83/EC) was amended in 2003 (2003/63/EC), stipulating that clinical trials data used for marketing authorisation applications in the EU are required to be conducted in accordance with GCP. 

Applications to establish MRLs for new pharmacologically active substances must be submitted to the European Medicines Agency (EMEA) at least 6 months in advance of an application for a marketing authorisation. In order to avoid delays, manufacturers are advised to submit an application once all the necessary data are available, as a product authorisation carmot be granted unless established MRLs are in place. The EMEA should be notified of the intent to submit an application 3 to 4 months in advance of the anticipated date, so that a Rapporteur and Co-Rapporteur can be appointed from among the members of the Committee for Veterinary Medicinal Products (CVMP). 

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... 

Volume 2A Notice to applicants—Medicinal products for human use—Procedures for marketing authorisation Volume 2B Notice to applicants—Medicinal products for human use—Presentation and content of the dossier Volume 2C Notice to applicants—Medicinal products for human use—Regulatory guidelines Commission of the European Communities, Luxembourg, 1998/1998/ 1999 (and amendments)... 

This is the name of what we used to know simply as the data sheet, or colloquially as the package insert. The SPC is the document that must be submitted in draft by companies to the MHRA/Reference Member State/European Medicines Evaluation Agency upon application for a marketing authorisation and, once approved, must then be provided to prescribers or suppliers of medicines, either with the product or at the time of promotion or within the previous 15 months of promotion of the product, written or verbal. The SPC includes the prescribing information for the product and represents the product licence approval for the medicine (see Section 12.2.1.1). It is the definitive statement between the competent authority and the company and, more importantly, is becoming the common basis of communication between the... 

Patent protection under general law usually lasts for up to around 20 years. This creates a difficulty in relation to medicinal products, as it can take some 12 years for the products to undergo research, development, the extensive clinical trials that are required in order to obtain a marketing authorisation and the authorisation process itself. These steps are also extremely expensive. The amount of time that remains during which the patent holder can exploit his patent and recoup his massive investment can be severely curtailed in relation to medicinal products. For this reason, the European Community has provided a form of additional patent-related protection for medicinal products authorised within the European Community, by means of a Supplementary Protection Certificate. A patent holder may apply for a certificate that takes effect at the end of the term of the basic patent, for a period equal to the period that elapsed between the date on which the application for the basic patent was lodged and the date of the first authorisation to place a product derived from the patent on the market in the Community, reduced by a period of 5 years. The maximum duration of the certificate is 5 years. The certificate applies to all medicinal products derived from the basic patent, but the additional time that can be obtained under the SPC is calculated in relation to the first product derived from the patent, authorised in the EU. 

The period of market exclusivity is 10 years from authorisation of the product. In the context of market exclusivity in the European Union, a Member State must not accept another application for a marketing authorisation or grant a marketing authorisation or accept an application to extend an existing marketing authorisation for the same therapeutic indication in respect of a similar medicinal product. However, exclusivity may be lost by the first applicant consenting to a second application from another applicant, if the first is unable to meet demand, if a similar product is found to be clinically superior, if the criteria are no longer met or if, at the end of 5 years, a Member State can show that the product is (excessively) profitable. 

The Member State appointed as RMS will have 120 days in which to prepare the draft documents. During this step, the clock may be stopped for a period of up to 3 months (which could be extended) for the applicant to prepare responses to any issues that may have merged. This will be followed by a 90-day European step during which to reach an agreement. If an agreement is reached, this will be followed by a national step in each Member State for the grant of the marketing authorisation. 

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. 

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. 

In certain cases companies may wish to obtain more than one marketing authorisation for the same medicinal product, through either simultaneous or subsequent applications. A specific procedure has been agreed for this between the EMEA and the European Commission. Under this procedure, companies should inform both the EMEA and the Commission Services at the latest four months prior to submission of their intentions, in particular providing the Commission with an explanation of the underlying motives for the multiple application and their intentions regarding exploitation of any authorisations granted. 

Committee for Proprietary Medicinal Products (CPMP) and European Medicines Evaluation Agency CEM EA) Guidance for industry notes on various aspects of product development and registration in Europe, e.g., Excipients in the dossier for application for marketing authorisation of a medicinal product (111/3196/91) Web sites http //www.eudra.org/ emea/cpmp and http //www.eudra. org/w3/emea.html... 

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. 

For the application for a marketing authorisation clinical trials have to be performed. An official European body, the European Medicines Agency (EMA), assesses the therapeutic benefit risk ratio. 

An approach that tries to solve the problem more at the source is the so-called green pharmacy. In order to stimulate the development of more easily degradable medicines, both for human as well as for veterinary medicines, European guidelines are formulated. At the application stage to get a marketing authorisation the manufacturer has to give information about the effects of the medicine on the environment as well as an evaluation of those effects and measurements which have to be taken to prevent or reduce these effects [33-35]. When veterinary products are concerned, authorities can even deny the registration if the environmental risk is considered too big. Market authorisation can... 

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