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THE ELECTRONIC SUBMISSION OF MEDICINAL PRODUCT INFORMATION

The European Medicines 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:

Marketing authorization holders submitted electronically to the Agency information on all medicinal products for human use authorised or registered in the UE before 2 July 2012 in one of two ways:

 

  1. Pharmaceutical companies can develop tools to submit the 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. Since April 2012, data-entry and submission tools are available by the Agency to Small and Medium Sized Enterprises (SMEs) and to pharmaceutical companies, which have no in-house tools available yet.

 

Actiomed offers to the industry:

  • Selection and collection of the information required.

 

  • Submission of the information on Medicinal Products for Human use using the EV-WEB or throughout the Gateway tool that the company has for the transmission.

EMA organize information days and mandatory training courses to use the EV-WEB tool. The course certificate (“XEVMPD training program”) is a mandatory requirement to submit the information on Medicinal Products for Human use. Actiomed holds the required certificate which provides the necessary skulls to provide this task.

 

Fell free to browse our brochure in the link.

 
 
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