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

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PHARMACEUTICAL LEGISLATION ON NOTICE TO
APPLICANTS AND REGULATORY GUIDELINES FOR
MEDICINAL PRODUCTS FOR HUMAN USE
An Academic presentation by Dr. Nancy Agens,
Head, Technical Operations, Pepgra
Group www.pepgra.com Email sales.cro_at_pepgra.com
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Today's Discussion
Notice to Applicants
OUTLINE OF TOPICS
Volume 2 Volume 2A Marketing Authorization
Volume 2B Format and Presentation Volume 2C
Regulatory Guideline Conclusion
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Notice to Applicants
The European Commission in tandem with proficient
authorities from the Member States, the European
Medicines Agency along with interested parties
created the Notice to Applicants (NTA). This
was done with the objective to fulfil the
obligations of the commission with regards to
article 6 of Regulation (EC) No. 726/2004, and
with regards to the Annex I to Directive
2001/83/EC as per the amendments. Publication of
the NTA is now under the following
volumes Volume 2A deals with all processes
pertaining to marketing authorization. Volume 2B
handles every format and presentation of
application dossier. Volume 2C tackles issues
pertaining to regulatory guidelines.
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Volume 2
As per volume 2 of the publication, the rules
that oversee medicinal products within the
European Union comprise of a list of regulatory
guidelines that is 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.
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Volume 2A Marketing Authorization
A medicinal product can only be placed in the
market within the European Economic Area (EEA)
in the event marketing authorization has been
duly issued by a competent authority from a
member state for their own region or when the
grant of authorization has been in tandem with
Regulation (EC) No 726/2004 for the whole
Union. It is essential that the holder of the
marketing authorization has been established in
the EEA. Pertinent responsible authorities from
member states would be responsible for providing
marketing authorization for medicinal products
that are placed within the markets, other than
medicinal products that have been authorized as
per Regulation (EC) No 726/2004.
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Volume 2B Format and Presentation
Volume 2B is associated with the presentation and
application dossier and it was initially made
public as a distinct volume during 1998. It
offers guidance with regards to dossier
compilation in order to apply for European
marketing authorizations and is applicable for
the centralized process and nationalized
processes. This update takes into consideration
the international agreements related to the
format and structure of the Common Technical
Document (CTD). From July, 1st 2003 onwards,
every application was supposed to be made as per
the EU- CTD presentation as mentioned during the
July, 2003 edition of the NTA, Volume 2B or any
later updates.
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Volume 2C Regulatory Guideline
Every application for variation needs to be
presented using the EU-CTD format. Nonetheless,
any cross-references to old EU format
documentation will be accepted as the content
would be more or less the same. 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
Regulatory 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.
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Conclusion

• Here only a cross-reference to an authorized data
  that already existed is needed.
• Cross-references of such kind could still be made
  to the pertinent old format dossier.
• Nonetheless, if the holder of the marketing
  authorizations opts to take the opportunity to
  present the (unaltered) data in the format of the
  new CTD instead, this would be acceptable as
  well.
• This is because that it would enable any
  variations in future to be handled.

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