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Information on the EU Synchronisation of PSUR submission

SÚKL Information for Marketing Authorisation Holders on the EU Synchronisation of PSUR submission schemes of medicinal products authorised through national, mutual recognition and decentralised procedures.

Under the auspices of the Heads of Medicines Agencies an EU project on synchronisation of PSUR submission schemes has
been launched to ensure that medicinal products containing the same active substance follow the same PSUR (Periodic
Safety Update Report) submission scheme in all EU Member States. The Project is supported by EFPIA (European
Federation of Pharmaceutical Industries and Associations), AESGP (Association of the European Self-Medication
Industry) and EGA (European Generic medicines Association).

HBD – EU Harmonised Birth Date for submission of PSUR

The PSUR submission scheme is based on the product’s “birth date”. This date is usually linked to the marketing
authorisation date. The International birth date (IBD) is the date of the first marketing authorisation, the EU birth
date is the date of the first authorisation in Europe. Submission of PSURs is normally determined by the date of
national authorisation; these dates may differ in the various Member States. Thus, the same product of one marketing
authorisation holder can follow different PSUR schemes in the various EU Member States. This results in duplicate
work of both MAHs and competent authorities, which may even have negative impact on quality of the reports. Besides
that, original medicinal products and generics usually have different birth dates and therefore it is difficult to
ensure the same safety information in SPCs of similar products. The above mentioned problems may be substantially
reduced if all medicinal products with the same active substance have the same birth date within the EU,
i.e.
EU HBD (Harmonised birth date).

EU synchronisation of PSUR submission schemes

At the beginning of January 2006, marketing authorisation holders of original medicinal products were requested to
propose EU HBDs and corresponding DLPs (Data lock points) of their products. Their proposals were then adopted by the
Heads of Medicines Agencies. The regularly updated list of adopted EU HBDs and DLPs together with accompanying
documents and information on this project can be found on the HMA website. http://heads.medagencies.org/ (HoA Documents – Working Group on PSUR
synchronisation).

The project is based on the principle of common PSUR submission scheme according to HBD and assessment work shared by
Member States. The Member State in charge of making the PSUR assessment report for a particular active substance is
called the PSUR Reference Member State (P-RMS) and is indicated on the list of EU HBDs. The objective of PSUR
synchronisation project is to make only one PSUR version acceptable for all EU Member States.

The common submission scheme and shared assessment should bring the following benefits:

  • Marketing authorisation holders of original products make only 1 PSUR for the concerned product with
    active substance once every 3 years and this PSUR can be simultaneously submitted in all EU Member States.
  • marketing authorisation holders of generic products enjoy the same advantages and, where appropriate,
    may collaborate on the preparation of PSURs. The marketing authorisation holders of generic product are also expected
    to submit PSURs in accordance with EU HBDs and DLPs.
  • Competent authorities will be able to mutually share the assessment work of PSURs and harmonisation of
    SPC texts will become easier.

Information for marketing authorisation holders on the procedure for synchronisation of PSUR submission
schemes based on EU HBD 
 

For majority of products the introduction of EU HBD means that the PSUR submission schemes need to be changed.

Both the marketing authorisation holders and competent authorities will benefit from the synchronisation of PSUR
submission schemes of medicinal products authorised through national, mutual recognition and decentralised
procedures. Owing to the fact that under national legislation the synchronisation will cause a change in marketing
authorisation of the given medicinal product and that this change cannot be made ex officio, only upon request of the
marketing authorisation holder, the synchronisation can be successfully completed only if the concerned marketing
authorisation holder applies for a variation to marketing authorisation under Section 26a (3) of the Act on
Pharmaceuticals, i.e. a change in the date and submission periodicity of PSUR. The only exception to
the above procedure applies to marketing authorisations granted through mutual recognition procedure or decentralised
procedure where the Czech Republic is a Concerned Member State (CMS). In such cases legislation requires that the
decision of the Reference Member State (RMS) is recognised. If the RMS does not require the implementation of change
in the date and periodicity of PSUR submission by means of a variation to marketing authorisation, submission of such
application in CR is also not required.

The Institute recommends that marketing authorisation holders of medicinal products with HDB apply for a Type II
variation as soon as possible using the following guidance: 

  • Marketing authorisation holders of medicinal products authorised through national or mutual
    recognition procedures with CR acting as RMS
    with DLP from October 2005 to December 2007
    should apply for Type II variation before the end of 2007. In accordance with the EC recommendation to change the
    date and periodicity of PSUR submission on the Community level without application for variation (Notice to
    Applicants, Volume 9A, Part I., 6), and in view of Czech national regulations, the mutual recognition procedure on
    variation to marketing authorisation concerning medicinal products authorised through MRP with the Czech Republic as
    RMS will not be initiated; submission of a national application for variation in the Czech Republic will be
    considered sufficient.
  • Other marketing authorisation holders of medicinal products authorised through national or
    mutual recognition procedures with CR acting as RMS
    are recommended to apply for Type II variation at least
    6 months prior to the established DLP.
  • Marketing authorisation holders of medicinal products authorised through
    mutual recognition procedures with CR as CMS
    do not have to apply for Type II variation.  They should
    submit PSUR in accordance with the RMS requirements.

Marketing authorisation holders of original and generic products containing active substances for which CR is the
P-RMS (PSUR reference member state) will be contacted by the pharmacovigilance department of SUKL (during
transitional period 2006/2007) and requested to submit relevant PSURs.

Since it is in the public interest to make changes in PSUR submission schemes on the basis of HBD, as required by the
synchronisation project, we recommend that applicants submit simultaneously with the application form also a request
for waiver of costs reimbursement under Section 65 (2) (b) of the Act on Pharmaceuticals giving the reasons as quoted
bellow:

This application for Type II variation refers to the PSUR synchronisation based on HBD which is being conducted on
the EU level. This excercise is intended to ensure coordinated monitoring of product safety in the EU and, where
necessary, to ensure flexible incorporation of information following from submitted PSURs into the SPCs of concerned
medicinal products. Implementation of the above variation to marketing authorisation is conducted in the public
interest. Simultaneously, this variation will mean a change with implications for a wide scope of persons. Pursuant
to Section 65(2) of the Act on Pharmaceuticals, the above mentioned facts provide grounds for waiver of reimbursement
of costs incurred on the assessment of this application. On the grounds of the above mentioned facts we apply for a
waiver of cost reimbursement fees for activities performed in respect of the assessment of this application for a
variation to marketing authorisation for medicinal product  ……………….MA No..…………..
consisting in synchronisation of PSUR submission schemes based on EU HBD.  

Note: Pursuant to the Act on Administrative Fees the administrative fee of 2000,- Kč must be paid by the
applicant not later than upon submission of the application.