Regulatory News

In order to re-enforce the obligation of CEP holders to inform their customers in case of CEP revision, CEP suspension, withdrawal or negative outcome of an EDQM inspection, a commitment that needs to be signed by the applicant has been included in the CEP application forms for new applications and revisions/renewals. The signature of this commitment will be part of the criteria for validating the applications at receipt.

Moreover, following the revision of the system for revision/renewal of CEPs, the revisions/renewals application form has been updated accordingly. The revised form includes new categorisation tables and a revised invoicing sheet.

These forms should be used for any application submitted from 1st March 2010.

To download the updated version of application forms, click on the links below.
Application Form - Request for new Certificate of Suitability
Application Form - Request for Revision or Renewal of Certificate of Suitability

The European Medicines Agency and EUnetHTA will be considering how the information on the assessment of the risks and the benefits of a medicine contained in the EPARs can best be used in the assessment of the relative effectiveness of new medicines carried out by health technology assessment bodies in the Member States.

We have launched a new section of our website specifically for the pharmaceutical industry. The section, which has been developed following feedback from users, provides targeted links to information throughout the site, as well as content relevant to industry.

The AGES PharmMed now accepts the purely electronic submissions for human use without additional paper copy, except for those documents that need to be signed: Company letter and application form.
By the AGES PharmMed is strongly recommended that correspond to the eCTD electronic submissions or Nees standard. In this connection it is pointed out that the eCTD is the preferred standard, and it is the default Nees is only a temporary solution.
The electronic filing is in the AGES PharmMed currently not mandatory, it will continue to accept submission in paper form.