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EudraLex - Volume 2 - Pharmaceutical legislation on notice to applicants and regulatory guidelines for medicinal products for human use

Volume 2 of the publications "The rules governing medicinal products in the European Union" contains a list of regulatory guidelines related to procedural and regulatory requirements such as renewal procedures, dossier requirements for Type IA/IB variation notifications, summary of product characteristics (SmPC), package information and classification for the supply, readability of the label and package leaflet requirements.

The Notice to Applicants below has been prepared by the European Commission, in consultation with the competent authorities of the Member States and the European Medicines Agency (EMA). This Notice has no legal force and does not necessarily represent the final views of the Commission. In case of doubt, therefore, reference should be made to the appropriate Union Directives and Regulations.

The Notice to Applicants was first published in 1986 and is regularly updated.

Volume 2A - Procedures for marketing authorisation

  • Chapter 1 - Marketing Authorisation (updated version - July 2019)
  • Chapter 2 - Mutual Recognition (updated version - February 2007)
  • Chapter 3 - Union Referral Procedures (updated version - November 2018)
  • Chapter 4 - Centralised Procedure (deleted - July 2015).
    The European Medicines Agency is responsible for the scientific evaluation of applications for European Union (EU) marketing authorisations for human and veterinary medicines in the centralised procedure. As the Agency provides relevant information and guidance for companies and individuals involved in developing and marketing medicines for human use in the Union no dedicated chapter on the centralised procedure has been included in the NTA. To be noted that this guidance is not a NTA document anymore. Regular update of this guidance will be available directly on the relevant website.
  • Chapter 5 - Guidelines of 16 May 2013 on the details of the various categories of variations, on the operation of the procedures laid down in Chapters II, IIa, III and IV of Commission Regulation (EC) No 1234/2008 of 24 November 2008 concerning the examination of variations to the terms of marketing authorisations for medicinal products for human use and veterinary medicinal products and on the documentation to be submitted pursuant to those procedures - C (2013) 2804 (OJ C 223, 2.8.2013, p. 1–79) and its addendum - C/2021/3888 (OJ C 215I , 7.6.2021, p. 1–2).

  • Chapter 6 - Community Marketing Authorisation (updated version - November 2005)

    Please also note the notice of 12/10/2009:

    "Droit de regard" : Important notice to stakeholders - follow-up to the notice of 29/07/09

    Following an agreement with the responsible Committee in the European Parliament and in accordance with the interinstitutional agreement of 3 June 2008, the period of the "droit de regard" for the Commission Decisions taken as part of the "Decision making process" is shortened on a permanent basis to 7 days. This applies also in the recess periods of European Parliament.

    The shortened period of the "droit de regard" does, however, not apply in the following cases:

    • the draft Commission Decision is not in accordance with the scientific opinion of the EMA;
    • Member States, during the vote, request that the draft Decision is discussed in a plenary meeting of the Standing Committee; or
    • the opinion of the Standing Committee is unfavourable.

    The "Notice to applicants", Chapter VI, is going to be updated to this effect.

    This arrangement applies with immediate effect, i.e.:

    • Procedures in the Comitology phase which have been in the "droit de regard" stage for more than 7 days are going to be moved into the adoption phase (15 calendar days);
    • Procedures in the Comitology phase which are still in the voting phase of Member States will be subject to a shortened period of "droit de regard" of 7 days.

    In practice, the additional 7 days of the "droit de regard" following the vote by Member States will be used to prepare the final Decision for adoption once the 7 days have expired. Therefore, in practice, the timelines will not be much affected by the "droit de regard".

    Companies are kindly requested to refrain from ringing up the Commission staff to "urge" a faster processing of the draft Decision of "their" products.

  • Chapter 7 - General Information
    Information regarding human medicinal products authorised centrally and nationally (Mutual Recognition Procedure/DeCentralised Procedure) contained in this Chapter is transferred to EMA and CMDh websites respectively. An overview of documents replacing the previous sections of Chapter 7 with corresponding website references is available at the following address.

Therefore any reference to chapter 7 should be understood as reference to these webpages. However, guidelines and other interpretative documents to which references may be provided represent the views of their authors.

Volume 2B - Presentation and content of the dossier

Notice to Applicants, Volume 2B incorporating the Common Technical Document (CTD) (May 2008).

Electronic Application Forms

The use of the electronic Application Forms (eAF) is mandatory for all procedures from 1 January 2016. The eAFs must be used for all applications: authorisations, variations and renewals.

Content and requirements of application forms

From 1 January 2016 the paper (Word) application forms are not to be used for submissions anymore. They are available in PDF only for information concerning the content and requirements of the application forms.

Module 1.2 Application form (revision 14 - May 2019)

Variation

  • Application form for variation to a marketing authorisation for medicinal products (human and veterinary) to be used in the mutual recognition and the centralised procedure (July 2018) - PDF version

Renewal

  • Application form for renewal of a marketing authorisation (July 2018) - PDF version

Homeopathic Application Form

Paper (Word) application form is still available and can be used for submissions for homeopathic medicinal products.

Module 1.2 Homeopathic Application form (updated version - December 2016)

Volume 2C - Regulatory Guideline