EDQM: Guideline on requirements for revision/renewal of certificates of suitability to the European Pharmacopeia Monographers

To be in line with the revision of the EU Regulation on Variations to marketing applications, the system for revision/renewal of CEPs will change for all requests for revision received from 1st ...

Compassionate use of medicines in the European Union

This document describes how “compassionate use” programs may up in the European Union, and the role of the European Medicines Agency in these activities, in accordance with Article 83 of ...

EMEA: Procedure for orphan medicinal product designation – general principles

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.

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

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

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

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

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.

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 ...

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