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

Amount 2 associated with magazines “The rules governing medicinal items in europe” contains a summary of regulatory instructions pertaining to procedural and regulatory needs such as for example renewal procedures, dossier requirements for Type IA/IB variation notifications, summary of item faculties (SmPC), package information and classification for the supply, readability of this label and package leaflet needs.

The Notice to Applicants below is prepared by the European Commission, in consultation with all the competent authorities associated with Member States together with European Medicines Agency (EMA). This Notice doesn’t have force that is legal doesn’t always express the last views of this Commission. In case there is question, consequently, guide should really be meant to the correct Union Directives and Regulations.

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

Amount 2A – Procedures for advertising authorisation

  • Chapter 1 – Marketing Authorisation (updated variation – July 2019)
  • Chapter 2 – shared Recognition (updated variation – February 2007)
  • Chapter 3 – Union Referral treatments (updated version – 2018 november)
  • Chapter 4 – Centralised Procedure (deleted – July 2015). The European Medicines Agency accounts for the systematic evaluation of applications for European Union (EU) marketing authorisations for peoples and veterinary medications into the procedure that is centralised. While the Agency provides appropriate information and guidance for organizations and folks tangled up in developing and marketing and advertising medicines for individual used in the Union no committed chapter in the centralised procedure happens to be within the NTA. To be noted that this guidance is certainly not a NTA document any longer. Regular improvement with this guidance should be available right on the website that is relevant.
  • Chapter 5 – tips of 16 May 2013 regarding the information on the different kinds of variants, regarding the procedure regarding the procedures laid straight down in Chapters II, IIa, III and IV of Commission legislation (EC) No 1234/2008 of 24 November 2008 in regards to the study of variants to your regards to advertising authorisations for medicinal services and products for human being usage and veterinary products that are medicinal from the paperwork 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”: crucial notice to stakeholders – follow-up to the notice of 29/07/09

    After an understanding utilizing the accountable Committee into the European Parliament as well as in conformity aided by the interinstitutional contract of 3 June 2008, the time scale for the “droit de respect” for the Commission choices taken included in the “Decision making procedure” is reduced for a permanent foundation to 1 week. This is applicable additionally within the recess durations of European Parliament.

    The period that is shortened of “droit de respect” does, but, not use when you look at the following instances:

    • The draft Commission Decision is certainly not prior to the opinion that is scientific of EMA;
    • Member States, throughout the vote, request that the draft choice is talked about in a plenary conference of this Standing Committee; or
    • The opinion for the Standing Committee is unfavourable.

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

    This arrangement is applicable with instant impact, in other words.:

    • Procedures within the Comitology period that have been within the “droit de respect” phase for longer than 1 week will probably be relocated to the use stage (15 calendar times);
    • Procedures within the Comitology stage that are nevertheless within the voting period of Member States will likely be at the mercy of a period that is shortened of de respect” of seven days.

    Used, the excess seven days regarding the “droit de respect” following vote by Member States would be utilized to organize the Decision that is final for 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 refrain from ringing up the Commission staff to “urge” a quicker processing of this draft choice of “their” products.

  • Chapter 7 – General Information details about individual medicinal services and products authorised centrally and nationwide (Mutual Recognition Procedure/DeCentralised Procedure) contained in this Chapter is used in EMA and CMDh websites correspondingly. A synopsis of papers changing the last chapters of Chapter 7 with corresponding site sources can be obtained in the after target.
    • For CMDh, see document en titled: “Transfer of information found in Notice to candidates, Volume 2A, Chapter 7”
    • For EMA:
      • Pre-authorisation
      • Post-authorisation

Consequently any mention of the chapter 7 must certanly be comprehended as mention of the these websites. But, instructions as well as other interpretative papers to which sources might be supplied represent the views of the authors.

Volume 2B – content and presentation associated with dossier

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

Electronic Application Types

Making use of the electronic applications (eAF) is mandatory for many procedures from 1 January 2016. 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 Answers (February 2008)
  • User guide when it comes to application form that is electronic
    • An individual guide when it comes to electronic form can be acquired on both CMDh internet site and eSubmission site. To be noted that this guide isn’t a essaypro review NTA document any longer and links are available with this web web page for information. Regular up-date for this typical document (for centralised and decentralised applications) will likely be available right on these internet sites.
  • Electronic Popular Technical Document (eCTD)
    • EU Module 1 Specification
  • Change Control Process for European eCTD Criteria
    • Change Control Process for European eSubmission Standards

Content and requirements of applications

From 1 2016 the paper (Word) application forms are not to be used for submissions anymore january. They truly are obtainable in PDF just for information in regards to the content and demands associated with the application forms.

Module 1.2 application (modification 14 – May 2019)


  • Application for variation to a marketing authorisation for medicinal products (peoples and veterinary) to be utilized when you look at the shared recognition together with centralised procedure (July 2018) – PDF variation


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

Homeopathic Application

Paper (Word) application continues to be available and may be applied for submissions for homeopathic medicinal items.

Module 1.2 Application that is homeopathic form version – December 2016)