General notices

Reporting of paediatric data for already approved medicinal products

The main objective of the Regulation of the European Parliament and of the Council on Medicinal Products for Paediatric Use (EC) No 1901/2006 and (EC) No 1902/2006) is to improve children's health by better regulation of medicines intended for paediatric use. As a first step to achieving this goal an agreement has been made between EMEA and CMD (h) regarding reporting of paediatric data for already approved medicinal products. Marketing authorisation holders must submit the data according to the guidance document that can be found in batch of documents. More...

Fees

Fees for Marketing Authorisation Applications in the Republic of Slovenia - I

Fees for Marketing Authorisation Applications in the Republic of Slovenia - II

Annual fees. More...

RMS request

Request for time slot for applications via the Decentralised Procedure (DCP) with Slovenia as Reference Member State (RMS)

Electronic submission

In accordance with the HMA (Heads of Medicines Agencies) meeting agreement on the 28th of February 2005 in Reykjavik, the Agency for Medicinal Products and Medical Devices of the Republic of Slovenia (JAZMP) plans to be ready for the reception, management and review of submissions in the e-CTD format submitted through the national procedure, MRP or DCP by the end of the year 2009. More...