Pharmaceutical Services

    The applicant informs the Medicines Council that he is interested in registering a specific product using the Administrative Zero Days MRP (initial wave) or, Repeat Use Zero Day (rMRP) procedure by completing the relevant form, "Intention Form for Administrative Zero Days MRP (initial wave)" and "rMRP Intention Form" respectively. The forms are available in the “application form” section of the website.

    Along with the form, the applicant must provide the approved product information (SPC, PIL, labelling) translated into Greek and/or English (where those approved in the Reference Member State are not in Greek or English).

    For the submission of the application, the respective national requirements of Cyprus apply as for all applications.

    The applicant must also submit the complete product dossier together with all subsequent variations approved by the Reference Member State (RMS). In addition, a summary list of these variations and a confirmation of their approval must also be submitted. The submission of an updated product dossier by the applicant, if available, will speed up the evaluation process.

    Either in the cover letter or in a separate declaration, the applicant must clearly declare that the dossier of the medicinal product submitted is identical to that currently approved in the Reference Member State (RMS).