Where applications for marketing authorisation of medicinal products of particular strengths and pharmaceutical forms only are being submitted, the related dossier should contain data relevant for the marketing authorisation of these strengths and pharmaceutical forms only. Should the dossier contain data concerning other strengths or pharmaceutical forms, for which applications for marketing authorisation are not submitted and which are not necessary in support of conducted studies, in the validation comments the applicant for marketing authorisation will be recommended to remove such data from the dossier or to submit additional applications for marketing authorisation of these strengths or pharmaceutical forms or provide a detailed justification for keeping the data in question in the dossier. The concerned recommendation or the request for the detailed justification will be stated in the validation comments of applications submitted via the national procedure, DCP and MRP with the Czech Republic as the Reference Member State.
Below please see further notice resulting from frequent deficiencies discovered during the validation of applications for marketing authorisation. This notice should serve as recommendation for the applicants for marketing authorisation of medicinal products via the national procedure, DCP and MRP, advising what to focus on prior to the submission of these applications.
In the application form (eAF), it is necessary to:
- Submit a separate eAF for each medicinal product, i.e. each strength and pharmaceutical form
- Provide information solely for the concerned medicinal product that is the subject of the respective application
- Provide the full name of the active substance incl. the salt/hydrate or the base, if applicable
- Information in the eAF must be consistent with the submitted dossier, e.g.:
- Reference medicinal products in section 1.4 of the eAF must be consistent with the dossier (incl. module 1.5)
- Package sizes in section 2.2.3 of the eAF must be completely identical to that in the proposed SmPC, PIL and labelling (in module 1.3.1 for the PDF format and in the “working documents” folder for the MS word format)
- Data about the Qualified Person Responsible for Pharmacovigilance (QPPV) and the Pharmacovigilance System Master File (PSMF) in section 2.4.4 of the eAF must be consistent with modules 1.8.1 and 1.8.2
- The composition of the medicinal product in section 2.6.1 of the eAF must be consistent with modules 2.3.P and 3.2.P
- The names and addresses of companies provided in section 2.5 of the eAF must be consistent with modules 2.3 and 3.2
- Information in the eAF must be consistent with the submitted Annexes, i.e. manufacturing authorisation (Annex 5.6), manufacturing flow-chart (Annex 5.8), Good Manufacturing Practice (GMP) certificate (Annex 5.9), Letter of Access/Ph.Eur. Certificate (CEP) (Annex 5.10), Qualified Person declaration (Annex 5.22); the following, in particular, should be provided in the eAF:
- Relevant valid numbers of manufacturing authorisations and GMP certificates
- The same addresses of manufacturing sites of the medicinal product and of the active substance as those in Annex 5.8 and in the marketing authorisation dossier
- In addition to the manufacturing site address, also the administrative address of the manufacturer of the medicinal product and the active substance as well as of the manufacturer responsible for batch release, where different
In the dossier, it is necessary to:
- Submit all relevant parts of the dossier as per the chosen legal basis
- Submit the dossier in a readable format allowing for subsequent copying
- Submit only the current versions of Annexes – e.g. Proof of Establishment (Annex 5.3), manufacturing authorisation (Annex 5.6), GMP certificate (Annex 5.9), CEP (Annex 5.10);
- Literature references:
- Submit any literature referenced in the dossier
- Submit as full-text allowing for subsequent copying, in the English language (the Czech/Slovak language is acceptable only for national applications for which no MRP with the Czech Republic as the Reference Member State will be requested)
- Always submit product information (SmPC, PIL and labelling) also in the MS Word format
- Send the Active Substance Master File (ASMF) no later than at the time of submitting the application for marketing authorisation
The most frequent deficiencies in submission of applications for marketing authorisation, for marketing authorisation renewal, or variations to marketing authorisation and applications for exception from the Sunset Clause were presented to regulated entities on a seminar organised by the Marketing Authorisation Section in 2019; the presentation from this lecture is available at:
Marketing Authorisation Section
4th February 2022
cz