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EMEA: Procedure for orphan medicinal product designation – general principles

01.02.2010
Regulation (EC) No 141/2000 of 16 December 1999 lays down a community procedure for the designation of medicinal products as an orphan medicinal products and the criteria for designation orphan ...

EMEA: Addendum to the Note for guidance on Evaluation of Medicinal Products Indicated for Treatment of Bacterial Infections.

01.02.2010
This addendum has been produced in response to recent advances in the development of agents intended for the treatment of the disease due to Mycobacterium tuberculosis. ...

EMEA: Guideline on clinical evaluation of diagnostic agents

01.02.2010
Overview of comments on draft guideline on clinical evaluation of diagnostic agents. ...

CMD(h)Recommendations on submission dates for Applicants of the DCP

22.01.2010
This document was produced by the CMD(h) in order to facilitate planning of submission dates of new applications going trough the decentralised procedure ...

CMD(h): Flow chart of the Decentralised Procedure

22.01.2010
The Heads of Medicines Agencies together with MRFG and VMRFG have agreed a flow chart for the DCP ...

EMEA: QRD recommendations on the expression of strength in the name of centrally authorised human medicinal products.

22.01.2010
Directive 2001/83/EC requires a medicinal product labeled as invented name – strength-pharmaceutical form. The strength in the name of the product is the quantity of the active substance which ...

EMEA: Paediatric investigation plans (PIPs), waivers and modifications - Procedural Advice

04.01.2010
This procedural advice addresses a number of questions which applicants may have before submitting an application. The information provided - under the form of Questions and Answers - will be ...

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