THE ELECTRONIC SUBMISSION OF MEDICINAL PRODUCT INFORMATION

The Agency published the format for the electronic submission of information on medicinal products for human use authorised or registered in the Union as provided in Article 57(2), second subparagraph of Regulation (EC) No. 726/2004:

By 2 July 2012 at the latest, marketing authorisation holders shall electronically submit to the Agency information on all medicinal products for human use authorised of registered in the UE in one of two ways:

1. Pharmaceutical companies can develop tools to initiate the electronic submissions of information on medicinal products in full compliance with the data elements and the XSD schema as described in the Detailed Guidance via the EudraVigilance Gateway to the Agency.
2. From February 2012: data-entry and submission tools will be made available by the Agency to Small and Medium Sized Enterpises (SMEs) and to pharmaceutical companies, which have no in-house tools available yet.

Actiomed offers to the industry:

• Collection of the information required at the pharmaceutical company’s site.

• Submission of the information on Medicinal Products for Human use using the EV-WEB or throughout the Gateway tool previously developed by each pharmaceutical company.

 EMA have organized information days and training courses mandatory to use the EV-WEB tool. The course certificate (“XEVMPD training programmes”) is a mandatory requirement to submit the information on Medicinal Products for Human use. Actiomed personnel own the certificate which proves the necessary skills to carry out this task.

Check out our brochure in the Download area.