PSUR Work Sharing for Veterinary Medicinal Products

The first ESS work-sharing initiative is focused on increasing the effectiveness and efficiency of the work generated by the preparation and assessment of Periodic Safety Update Reports (PSURs). Submission and assessment of PSURs represent indeed a heavy burden for industry and MSs Competent Authorities respectively. To allow MSs to share the assessment work amongst them, ESS proposes to synchronise the submission of PSURs.
 
In order to achieve this PSUR synchronisation, products' Birth Dates (BD) and Data Lock Points (DLP) need first harmonising across the EU countries. The ESS actually proposes to go further and adopt one EU BD per active substance (or combination of active substances). This will allow industry to prepare one PSUR per product for simultaneous submission to all EU concerned member states; thus this initiative is supported by the EU veterinary pharmaceutical industry associations, namely IFAH-Europe and EGGVP, see the links to the right. It will further allow the authorities to share the assessment work amongst them selves.

The Plan

A sub-group (PSUR Synchronisation Sub-Group - PSSG) of representatives from authorities and European veterinary pharmaceutical industry has been set-up to get this project running.  It is especially responsible for proposing harmonised birth dates, data lock points and PSUR submission dates in the EU.

Harmonised EU birth dates and data lock points will be set by mutual agreement between the member states and the originator (originator is generally first MAH to register/market an active substance or combination of active substances  in the EU) marketing authorisation holders. Once agreement has been reached these dates will be published on the Heads of Medicines Agencies (veterinary) website, see the link to the right. It is expected that MAHs of generic products (including other types of authorisations) will adopt the same dates for their related products, i.e. those containing the same active ingredient(s) or combinations as the originator's.

Although the whole scheme is based upon voluntary cooperation between competent authorities and industry, the advantage for MAHs with a same product marketed in several EU-counties is clear: one PSUR every three years, valid for all EU-countries and submitted simultaneously to all EU-countries.

All EU regulatory authorities have agreed to accept the changes in timings of PSUR submissions that will result from the harmonised EU birth dates.

Initially the scheme will focus on chemical synthetic substances and vaccines which have been authorised under national, mutual recognition or decentralised procedures and will not include herbals, homeopathics or blood products.

The Pilot Phase

A Pilot Phase is being initiated for a selected list of actives - see Annex I. Your contribution to the running of this pilot phase, where applicable, is therefore kindly requested.

Annex I presents a list of  active substances (including some combinations to be regarded as a “fixed combination equal to one substance”) with the originator MAH, a harmonised birth date and a harmonised pan-European data lock point to be used in preparing PSURs. The last column shows the EU-country who will perform the PSUR assessment for this active. Procedures and timelines for the assessments are identical to those currently used for handling renewals. This member state can be called the 'PSUR Reference Member State'.

Due to special features of immunological veterinary medicinal products (IVMPs) such as vaccines the procedure for these products needs refining and is summarised in Annex II.

Action required

MAHs with products containing substances/combinations of substances listed in the Annex to this letter are invited to follow the suggested dates for preparing and submitting PSURs to the authorities where the products are authorised. It is a great advantage that information on all indications, dosage forms and regimens for a given substance authorised to one MAH should be included in a single document. For each formulation, data may however be presented individually in different PSUR-sections or separate PSURs as appropriate. Regarding the contents and format of the PSUR, MAHs are referred to the Notice to Applicants Volume 9B.

It is further strongly recommended to add a covering letter to the PSUR to inform the authorities that you are taking part in the pilot phase.

The outcome of the Pilot Phase will be of great importance to measure the savings in time and effort and increased quality of the work generated by PSURs, both for industry and authorities.

Practical details of implementation will be communicated later on the HMA website at: www.hma.eu/veterinary, see the link to the right.

Contact points for clarification:
Dr. Erik Deroover – deroove@wyeth.com – Fort Dodge Animal Health on behalf of IFAH-Europe
Dr. Ton Kamphuis – t.kamphuis@cbg-meb.nl – Dutch Medicines Evaluation Board on behalf of  ESS

Annex I : Active substances participating in the Pilot Phase

Annex II: Immunological Veterinary Medicinal Products (IVMPs)

The Plan for IVMPs

The approach used for pharmaceutical products is not applicable for vaccines and other IVMPs mainly due to the variations in antigen and adjuvant composition but also due to differences in important production steps such as inactivation or attenuation procedures. Therefore consensus was reached to keep the PSURs for IVMPs generally at the individual product level. The advantage for MAHs with a same product marketed in several EU-counties is still obvious: one PSUR valid for all EU-countries and to be submitted every three years. The situation for the PSUR submission with one agency acting as the PSUR RMS will then be similar to the MR/decentralised procedure.

The harmonised EU birth date for an IVMP will be set by mutual agreement between the MAH and the member states.

The Pilot Phase

For the pilot phase, it was proposed to start with monovalent rabies vaccines. 3 yrs PSURs (5 yrs in case of gap - overlapping is accepted) can be submitted according to a company calendar, provided it is submitted by September 2008.
The German Paul Ehrlich Institute will act as the PSUR RMS.
It is recommended to add a covering letter to the PSUR to inform the authority that you are taking part in the pilot phase.