Update on e-CTD submission in Czech Republic
„Special cases“ according to updated guideline REG-84- submission in eCTD format,
released 02.10.2008.
The following shall be considered special cases:
- Situations when, should the application remain pending due to the failure to submit source materials in the eCTD electronic format, the health of the patient would be jeopardised due to unavailability or shortage of the concerned medicinal product on the market (E.g. the conduct of safety-related variations to marketing authorisation, marketing authorisation renewals for medicinal products which cannot be therapeutically interchanged, applications for marketing authorisation of products containing new active substances in the Czech Republic, applications for marketing authorisation of products containing a new combination of active substances, applications for marketing authorisation containing a new indication, new strength and new pharmaceutical form, applications for marketing authorisation, MA renewals or variations to MA of a product intended for paediatric use, applications for marketing authorisation of a product submitted as “line extension“);
- Situations when, should the application remain pending due to the failure to submit source materials in the eCTD electronic format, unjustified higher costs to be covered by the public health insurance would arise (e.g. delayed marketing of a cheaper generic product);
- European MA procedures (MRP and decentralised procedure), where the Czech Republic is the Concerned or Reference Member State;
- Inclusion of a previously authorised medicinal product in a Mutual Recognition Procedure (REG-80);
- Any applications for variations to or renewals of marketing authorisation of products which have been authorised via so called national procedure where documentation in the NTA format has been submitted with the original application for marketing authorisation (the application for marketing authorisation has been submitted before 11 May 2004); the submission of the application must include a proper justification that the products concerned are medicinal products the marketing authorisation of which was applied for before the coming into force of Decree No 288/2004 Coll. (Marketing Authorisation Decree);
- Amendments to marketing authorisation dossiers within the scope of pending administrative procedures;
- Other cases where the applicant provides an adequate rationale of why the application cannot be declined due to the failure to submit documentation in electronic format with a view to the public interest, public health and/or availability of an effective therapy.
Any special case must be properly documented by the applicant, i.e. the applicant shall be obliged to provide a written rationale for submitting the application and dossier in a format other than the eCTD.
