EudraLex – amount 2 – Pharmaceutical legislation on notice to candidates and regulatory recommendations

EudraLex – amount 2 – Pharmaceutical legislation on notice to candidates and regulatory recommendations

Amount 2 associated with magazines “the guidelines regulating products that are medicinal the European Union” contains a summary of regulatory tips pertaining to procedural and regulatory requirements such as for example renewal procedures, dossier requirements for Type IA/IB variation notifications, summary of item characteristics (SmPC), package information and category for the supply, readability regarding the label and package leaflet demands.

The Notice to Applicants below was made by the Commission that is european assessment utilizing the competent authorities associated with Member States and also the European Medicines Agency (EMA). This Notice doesn’t have force that is legal will not fundamentally express the ultimate views for the Commission. In the event of doubt, consequently, guide must certanly be designed to the correct Union Directives and Regulations.

The Notice to Applicants was posted in 1986 and it is frequently updated.

Amount 2A – Procedures for advertising authorisation

  • Chapter 1 – Marketing Authorisation (updated variation – 2019 july)
  • Chapter 2 – Mutual Recognition (updated variation – February 2007)
  • Chapter 3 – Union Referral treatments (updated variation – November 2018)
  • Chapter 4 – Centralised Procedure (deleted – July 2015). The European Medicines Agency accounts for the medical assessment of applications for European Union (EU) marketing authorisations for human being and veterinary medications into the centralised procedure. No dedicated chapter on the centralised procedure has been included in the NTA as the Agency provides relevant information and guidance for companies and individuals involved in developing and marketing medicines for human use in the Union. To be noted that this guidance is certainly not a NTA document anymore. Regular improvement with this guidance are going to be available entirely on the website that is relevant.
  • Chapter 5 – tips of 16 May 2013 regarding the information on the many kinds of variants, from the procedure for the procedures laid down in Chapters II, IIa, III and IV of Commission legislation (EC) No 1234/2008 of 24 November 2008 regarding the study of variants to your regards to advertising authorisations for medicinal items for individual usage and veterinary medicinal items and regarding the documents to be submitted pursuant to those procedures – C (2013) 2804 (OJ C 223, 2.8.2013, p. 1–79).
    • PDF variation (might 2013)
    • Word version (might 2013)
  • Please additionally note the notice of 12/10/2009:

    “Droit de respect”: essential notice to stakeholders – follow-up to the notice of 29/07/09

    After an understanding aided by the accountable Committee into the European Parliament plus in conformity with all the interinstitutional contract of 3 June 2008, the time scale of this “droit de respect” for the Commission choices taken included in the “Decision making procedure” is reduced for a permanent foundation to seven days. This is applicable additionally when you look at the recess periods of European Parliament.

    The shortened amount of the “droit de respect” does, but, maybe maybe perhaps not use when you look at the following cases:

    • The draft Commission choice isn’t prior to the medical viewpoint for the EMA;
    • Member States, throughout the vote, demand that the draft choice is talked about in a plenary meeting associated with Standing Committee; or
    • The opinion regarding the Standing Committee is unfavourable.

    The “Notice to candidates”, Chapter VI, is likely to be updated for this impact.

    This arrangement is applicable with instant impact, for example.:

    • Procedures when you look at the Comitology stage that have been into the “droit de respect” phase for longer than 1 week will be relocated in to the adoption stage (15 calendar times);
    • Procedures into the Comitology period that are nevertheless into the voting period of Member States is going to be at the mercy of a shortened amount of “droit de respect” of 1 week.

    Used, the extra 1 week of this “droit de respect” after the vote by Member States will likely to be utilized to organize the concluding decision for use when the seven days have actually expired. Consequently, in training, the timelines won’t be much affected by the “droit de respect”.

    Organizations are kindly required to keep from ringing up the Commission staff to “urge” a quicker processing of this draft choice of “their” products.

  • Chapter 7 – General Information details about peoples medicinal items authorised centrally and nationwide (Mutual Recognition Procedure/DeCentralised Procedure) found in this Chapter is used in EMA and CMDh sites correspondingly. A summary of documents changing the prior chapters of Chapter 7 with corresponding site sources can be obtained during the after address.
    • For CMDh, see document en titled: “Transfer of information found in Notice to applicants, Volume 2A, Chapter 7”
    • For EMA:
      • Pre-authorisation
      • Post-authorisation

Consequently any mention of the chapter 7 should always be recognized as mention of these websites. Nevertheless, recommendations along with other documents that are interpretative which recommendations can be supplied represent the views of these writers.

Amount 2B – content and presentation associated with dossier

Notice to candidates, amount 2B including the most popular Technical Document (CTD) (might 2008).

Electronic Application Forms

Making use of the electronic Application Forms (eAF) is mandatory for many procedures from 1 2016 january. The eAFs can be used for many applications: authorisations, variants and renewals.

  • ESubmission: EU Electronic applications (Module 1.2 application, variation and renewal types)
  • Concerns and responses (2008 february)
  • User guide for the application form that is electronic
    • An individual guide when it comes to electronic form can be acquired on both CMDh site and eSubmission site. To be noted that this guide is certainly not a NTA document any longer and links are available about this web web page for information. Regular improvement of the document that is commonfor centralised and decentralised applications) would be available right on these internet sites.
  • Electronic Common Technical Document (eCTD)
    • EU Module 1 Specification
  • Change Control Process for European eCTD Criteria
    • Change Control Process for European eSubmission Criteria

      Content and requirements of application forms

      From 1 2016 the paper (Word) application forms are not to be used for submissions anymore january. These are generally for sale in PDF just for information in regards to the content and needs regarding the applications.

      Module 1.2 form (modification 14 – May 2019)


      • Application for variation to an advertising authorisation for medicinal items (peoples and veterinary) to be used into the mutual recognition plus the centralised procedure (July 2018) – PDF variation


      • Application for renewal of an advertising authorisation (July 2018) – PDF variation

      Homeopathic Form

      Paper (Word) application form continues to be available and certainly will be applied for submissions for homeopathic products that are medicinal.

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

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