This integrated version has been created for printing purposes only.Please refer to the individual question & answers as published in thepre-submission guidance for access to the hyperlinked information.

Questions and answers are being updated continuously, and will bemarked by "NEW" or "Rev." with the relevant date upon publication.

This guidance document addresses a number of questions which usersof the centralised procedure may have. It provides an overview of the EuropeanMedicines Agency's position on issues, which are typically addressed during thecourse of pre-submission meetings.

It will be updated regularly to reflect new developments, to includeguidance on further pre-authorisation procedures and to reflect the implementationof the new European legislation. Revised topics will be marked by "New" or "Rev"upon publication.

The EMA emphasises the importance of pre-submission meetings betweenapplicants and the EMA/(Co-) Rapporteur. Pre-submission meetings (which shouldtake place approximately 7 months prior to the anticipated date of submissionof the application) are a vital opportunity for applicants to obtainprocedural, regulatory and legal advice from the EMA. The product team isavailable to address any questions MAHs may have regarding their pre-authorisationapplication.

This guidance information and fruitful pre-submission meetings shouldenable applicants to submit applications, which are in conformity with thelegal and regulatory requirements and which can be validated speedily. Pre-submissionmeetings will also enable applicants to establish contact with the EMA staffclosely involved with the application as it proceeds.

Note:

It shouldbe highlighted that this document has been produced for guidance only andshould be read in conjunction with "The rules governing medicinal productsin the European Union", Volume 2A, Notice to Applicants.

Applicantsmust in all cases comply with all requirements of Community Legislation. Provisions,which extend to EEA countries (i.e. the EU member states, plus Norway, Icelandand Liechtenstein) by virtue of the EEA agreement, are outlined in the relevantsections of the text.

Document: European Medicines Agency pre-authorisation procedural advice for users of the centralised procedure