The types of application for the issuance of a national, MRP or DCP marketing authorisation are as follows:
1. Full application
2. Bibliographic application (for Well Established Use products)
3. Application for essentially similar pharmaceutical products (generic)
4. Hybrid application for products based on the dossier of a reference medicinal product, but differing from it in terms of content, pharmaceutical form, etc.
5. Application for products essentially similar to approved products for which, the consent of the holder of the existing marketing authorization is required in order to use the data contained in the dossier of his product (informed consent).
6. Fixed combination application
7. Similar biological products (products that use biological products as reference products)
8. Traditional medicinal products of plant origin
General information on the regulatory requirements for the submission of applications for the issuance of a marketing authorisation are available in “Volume 2A, Chapter 1 (Marketing Authorisation) of the Notice to Applicants” and the relevant applications are available in “Volume 2B of the Notice to Applicants” of the European Commission website ( https://ec.europa.eu/health/documents/eudralex_en )
Submission via CESP and the inclusion of the signed cover letter and the signed eAF in the CESP submission are mandatory.
During the validation of the content, the completeness and correctness of the electronic dossier is checked in accordance with the CMDh guidelines, which are located at the following link https://www.hma.eu/91.html
Additional national requirements are published on the CMDh website and are as follows:
1) A person responsible for pharmacovigilance resident in Cyprus
2) A person responsible for the provision of scientific services resident in Cyprus