Medicinal products marketing authorization procedures

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Overview on medicinal products marketing authorization procedures

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Medicinal products marketing authorization procedures https://www.regulatory-affairs.pl/en/medicinal-products.html

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The basic principles of EU law • The main types of EU legal acts – Regulations Regulation - do not require implementation - apply to all countries even if there are no such records in national law – Directives – not obligatory by itself but the Member States have an obligation to implement these provisions into national law – Scientific and procedural guidelines published by the working groups within the EMA ICH EC CMD 2

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The basic principles of EU law • Basic legislation for medicinal products – Directive 2001/83 as amended - regulates the requirements for human medicinal products including marketing authorization procedures dossier introduced CTD format the types of applications so called legal basis - for example generic hybrid WEU fixed combination introduces the European Pharmacopoeia Ph. Eur./EP as a source of basic quality requirements – Directive 2001/82 as amended - the equivalent of the above for veterinary medicinal products 3

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The basic principles of EU law • Basic legislation for medicinal products – Regulation 726/2003 as amended - establishes the European Medicines Agency EMA formerly EMEA responsible for the central procedure and the coordination of EU-wide projects including coordination of the development of scientific guidelines and procedural cooperation of national agencies etc.. – Directive 2003/94 on EU GMP – Regulation 1234/2008 introducing a new system of post- marketing variations the MRP DCP and the central procedure 4

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Marketing authorization procedures • National procedure • Mutual Recognition Procedure MRP • Decentralized procedure DCP • Central procedure 6

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National procedure • Marketing authorization of a medicinal product in single EU country • Dossier assessment in single country • Regulated by national legislation of particular country 7

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National procedure • Timeline: 210 days + clock-stop periods suspension of the process for the preparation of answers to questions • The first stage is a formal validation of the application and documentation fees completeness attached documents etc. • After successful completion of this stage the dossier is directed to the proper assessment of data 9

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MRP mutual recognition procedure • Applicable if the medicinal product is already registered in one of the EU countries and company wants to authorize it in the next EU country/countries • Formally mandatory if the same product has already been authorized the same MAH and the same composition in one of EU countries - the aim is the common assessment and as a result the same SmPC 11

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MRP mutual recognition procedure • A common assessment by all involved countries so called CMS - Concerned Member States • Country in which the product is already authorized acts as the RMS Reference Member State. RMS is responsible for procedure management and preparation of the assessment report for the procedure • The assessment report and the medicinal product dossier is then assessed by the CMSs 12

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MRP mutual recognition procedure • General principles MRP procedures are defined by the Directive 2001/83 • Timeline of the procedure: 90 days. Preceded by a three- month period to prepare an assessment report by the RMS and CMS 14-day validation stage for CMS countries which is similar to the national procedure validation procedure fees completeness of dossiers and formal documents • Important: there are no clock-stop periods - little time to prepare the answers. 13

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DCP procedure • The same medicinal product is to be authorized in parallel in several EU countries and it has not been authorized in the EU yet. • One of these countries is selected as the RMS country which is responsible for preparation of the preliminary assessment report while the rest of involved countries CMSs jointly review the assessment report and the medicinal product dossier • Timeline: 210 days + clock-stops • It ’ s now the most common procedure for marketing authorization in the EU 14

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Central procedure • The most complicated and most demanding procedure • Single assessment and single license issued by the European Commission on the basis of EMA assessment valid in all EU member states. • Assessment by chosen countries selected from CHMP or CVMP members. 16

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Central procedure • This procedure is mandatory for new therapies for HIV / AIDS neurodegenerative diseases eg. Alzheimers disease cancer diabetes and medicinal products which use recombinant DNA techniques. • The procedure is very expensive and demanding in terms of dossier studies and procedural issues. • Calendar of procedure: 210 days with clock-stop periods similar to the DCP calendar. 17