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Application Form preparation
One essential step in obtaining marketing authorisation for medicinal products is accurately preparing the application form. A correctly completed form ensures compliance with regulatory requirements and enables a smooth evaluation by the competent authorities.
Electronic Application Form
Since January 2016, the electronic Application Form (eAF) has been mandatory in all European procedures. While most submissions require the eAF, some National Competent Authorities (NCAs) still require country-specific forms for national procedures.
The eAF is a standardised digital document used in the following regulatory procedures in the EU:
- Centralised Procedure (CP),
- Decentralised Procedure (DCP),
- Mutual Recognition Procedure (MRP),
- National Procedures (NP) – in selected EU Member States.
The eAF is mandatory for both human and veterinary medicinal products and applies to initial marketing authorisation applications, post-authorisation changes (variations), and renewals.
The eAF enables a structured and consistent submission of critical information about the medicinal product, including:
- Product name, pharmaceutical form, and strength
- Legal status
- Manufacturing sites
- Applicant’s details.
Using the eAF improves regulatory efficiency, promotes transparency, and reduces the risk of errors during submission. It also facilitates evaluation by regulatory authorities such as the European Medicines Agency (EMA) and national regulatory agencies.
Application form for the national procedure in Poland
Despite the widespread use of the eAF, national procedures in Poland still require application forms to be submitted in Polish. Dedicated national templates are obligatory for both marketing authorisation procedures and post-authorisation variations procedures. A solid understanding of local requirements is therefore essential.
What should you consider while preparing an application form?
As with all regulatory activities, application forms must comply with current guidelines and requirements.
The eAF is continuously improved and updated. New, up-to-date versions, along with useful User Guides, are published on the eSubmission website.
The application form must be consistent with the dossier’s content – Modules 1 to 5 of the Common Technical Document (CTD).
Proper preparation of the eAF is crucial for regulatory success. Any inconsistencies, errors, or omissions may result in validation failures, delays in the evaluation process, requests, and the subsequent need for information supplements.
Why us?
Professional support in preparing the application form – whether eAF or national significantly – increases the chances of a smooth and positive outcome of the marketing authorization or post-authorization procedures. Our regulatory Experts ensure:
- accurate and complete form preparation,
- validation using the official eAF validation tool,
- correct formatting and integration into eCTD package,
- complete alignment with current legislation, EMA and CMDh guidelines, and national authority expectations.
Benefits of cooperation
With SciencePharma, staying updated with the ever-evolving regulatory landscape becomes much easier. We offer:
- Comprehensive support in preparing application forms (including eAF and application form for national procedures in Poland)
- Submission of regulatory dossiers
- Full marketing authorisation and post-authorisation services tailored to the specific needs of the Marketing Authorisation Holder
Let us simplify your regulatory journey, so you can focus on bringing your product to market.
If you are interested in working with us, please do not hesitate to contact us. Our Experts will answer all your questions and doubts.