Pharmacovigilance

Guidance documents on pharmacovigilance - Regulation (EU) 2019/6

Q&A on transitional arrangements from Directive 2001/82 to Regulation (EU) 2019/6

 

Guidance documents on pharmacovigilance - Directive 2001/82/EC

Periodic Safety Update Reports (PSURs)

Best practice guide on handling of PSURs in MRP/DCP

Best practice guide on handling of PSURs in EU PSUR worksharing (February 2021)

PSUR-algorithm

 

Reminder for Marketing authorisation holders concerning the submission of PSUR

For the submission of periodic safety update reports (PSUR) for MR/DC veterinary medicinal products, the CESP delivery file shall, in addition to all other relevant information, include all national product names with corresponding member state(s) as well as the procedure number. For identification purposes, names, member states and procedure number should be included in the cover letter.

For Workshare PSURs please mention the active substance covered by the workshare procedure, year and month of DLP and the PSUR RMS.

 

Detailed Description of the Pharmacovilance System (DDPS)

DDPS declaration instructions

DDPS declaration form

DDPS declaration form | Word

Following a 12 month pilot phase and based upon positive feedback from industry and agencies, the CMDv has agreed to continue the use of the 'DDPS declaration form' on an indefinite basis.

The declaration form may be used by an Applicant in all application procedures (MRP, DCP and National) for new marketing authorisations to notify National Competent Autorities of any previous assessment and approval of the same version of the DDPS.

Further clarification on using the DDPS declaration form is available in the above documents and from the chosen RMS.