Pharmaceutical Legislation On Notice To Applicants And Regulatory Guidelines For Medicinal Products For Human Use | Pepgra

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Notice to Applicants

The European Commission in tandem with proficient authorities from the Member States, the European  Medicines Agency along side interested parties created the Notice to Applicants (NTA). This was through with the target to fulfil the obligations of the commission with regards to article 6 of Regulation (European Union) No. 726/2004, and with regards to the Annex I to Directive 2001/83/EC as per the amendments. one among the primary editions of the Notice to Applicants (which is volume 2 within the series “The Rules governing medicinal products within the ecu Union) was initially published within the year 1986. 

Pharmaceutical legislation on notice to applicants and regulatory guidelines for medicinal products for human use.


This notice was subject to further revisions following which a completed version was issued i.e., the second edition was published in 1989(European Commision, 2020). Later, during 1993, the processes associated with applications for marketing authorizations were modified and therefore the mutual also as centralized regulation procedures came into force from 1995. Decision was then taken to segregate the presentational and procedural aspects of this guidance as volume 2A and 2B. afterward in 2000, a necessity was felt for further particular regulation based guidelines, which was acknowledged and a Volume 2C was created. Publication of the NTA is now under the subsequent volumes:

  1. Volume 2A deals with all processes concerning marketing authorization.
  2. Volume 2B handles every format and presentation of application dossier.
  3. Volume 2C tackles issues concerning regulatory guidelines.

However, it must be taken into consideration that this notice is barren of any legal force and doesn't essentially project the ultimate perspectives of the Commission. within the event that any doubt arises, it might be appropriate to draw regard to the acceptable Union Directives and Regulations.


Volume 2
As per volume 2 of the publication, the principles that oversee medicinal products within the ecu Union comprise of an inventory of regulatory guidelines that's linked with regulatory and procedural requirements like; procedures related renewal, dossier requirements for Type IA/IB variation notifications, summary of product characteristics, package information and classification for supply, label readability and requirements for package leaflets(European Commision, 2020).

Volume 2A – Marketing Authorization

A medicinal product can only be placed within the market within the ecu Economic Area (EEA) within the event marketing authorization has been duly issued by a competent authority from a member state for his or her own region (national authorization) or when the grant of authorization has been in tandem with Regulation (EC) No 726/2004 for the entire Union (union authorization). it's essential that the holder of the marketing authorization has been established within the EEA(European Commision, 2006). Pertinent responsible authorities from member states would be liable for providing marketing authorization for medicinal products that are placed within the markets, aside from medicinal products that are authorized as per Regulation (EC) No 726/2004(European Commision, 2006).

Volume 2B: Format and Presentation

Volume 2B is related to the presentation and application dossier and it had been initially made public as a definite volume during 1998. It offers guidance with regards to dossier compilation so as to use for European marketing authorizations and is applicable for the centralized process and nationalized processes. this is often inclusive of procedures that are decentralized and mutual recognition(CTD, 2003). This update takes into consideration the international agreements associated with the format and structure of the Common Technical Document (CTD) on which an agreement was reached during November, 2000 at the time of the international Conference on Harmonization (ICH) framework and extra documents and modified guidelines that are prescribed from then onwards.

Volume 2C: Regulatory Guideline


Following 1st of July, 2003, every application for variation must be presented using the EU-CTD format. Nonetheless, any cross-references to ‘old’ EU format documentation are going to be accepted because the content would be more or less an equivalent . Any clear regard to any ‘old’ format documentation is important . For instance;

  • Any new (either revised or additional) data in support of the variation is supposed to be submitted utilizing the CTD format.
  • In case any data is supposed to be submitted which is not changed, for instance, the Type I variation guideline might specify the necessity for submitting a copy of the approved specifications, then the marketing authorization holder needs to update the said specifications within the new CTD format. The holder of marketing authorization is also supposed to offer a declaration which would imply that the content of any document that has been reformatted is unchanged. Any kind of variation in the future application would then be in a position to utilize such updated (CTD) specifications
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