Submission of application via CESP system – the information of the President of the Office for Registration of Medicinal Products, Medical Devices and Biocidal Products

On the 23rd of  March 2017, the President of ORMP  published the information on the submission of applications via the CESP system. As of 3rd of April 2017,  MAHs will be able to submit the application to the Office for Registration of Medicinal Products, Medical Devices and Biocidal Products through the Common European Submission Platform - CESP, especially in reference to:

• obtaining marketing authorization of the medicinal product

• incepting post-registration changes
• re-registration.

The aforesaid regulations will apply to national and European procedures – the mutual recognition procedure (MRP) and  the decentralized procedure (DCP) regarding medicinal products for human and veterinary use.

All documents which required manual signature or original presentation will be accepted electronically with a secure electronic signature, verified by a valid qualified certificate.
In the situation of absence of an electronic signature on the required documents, it will be needed to submit them in a paper form. However, ORMP emphasizes that other forms of filing applications and documentation, including CD / DVD records or paper documents, will be still acceptable.

The communication is available under the following link:
http://www.urpl.gov.pl/pl/informacja-z-dnia-23032017-r-w-sprawie-sk%C5%82adania-wniosk%C3%B3w-wraz-z-dokumentacj%C4%85-za-po%C5%9Brednictwem