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EU CENTRALISED PROCEDURE Key steps and considerations …

I CPD withRegulatoryRapporteurJuly/August 2019 TOPRA 2019 Regulation 726/2004/EC1 lays down community procedures for the author-isation and supervision of medicinal products for human and veterinary use and establishment of the European Medicines Agency (EMA). The CENTRALISED PROCEDURE (CP) makes provision for submission of a single new marketing authorisation application (MAA) to the EMA with scientific assessment being conducted by a rapporteur/co-rapporteur, and assess-ment of the risk management plan by the Pharmacovigilance Risk Assessment Committee (PRAC).

decentralised procedure is possible as long as a suitable justification can be given that it would represent a significant therapeutic, scientific or technical innovation, or that its authorisation would be in the interest of patients at a community level. The CP assessment process

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MEDICAL DEVICES: FDA regulatory pathways for ... - TOPRA

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Class I devices have the least regulatory requirements. Under current law, Class I devices are defined as those for which general controls “are sufficient to provide reasonable assurance of the safety and effectiveness of the device”.11 Many Class I devices are exempt from the pre-market notification and/or the quality system (QS) regulation

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The procedure number is the Mutual Recognition Procedure number allocated by the RMS. “First Use” means the first Mutual Recognition Procedure. All the concerned Member states should be indicated. “Repeat use” means a new use (“wave”) of the same mutual recognition or decentralised procedure made to include new concerned member ...

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accepted via the Decentralised Procedure, provided that the same Reference Member State is used. The BfArM is a Federal Institute within the portfolio of the Federal Ministry of Health Federal Institute for Drugs and Medical Devices DCP/MRP BAH- WiDi 22. 03. 2011 18

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mutual recognition, decentralised or centralised procedures . Additional information on labelling/package leaflet that may be required or permitted nationally in accordance with Articles 58 and 64 of Directive 2001/82/EC, as amended, is outlined below. Index

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