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PSURs cycle

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Question 1
In accordance with Article 104(6) of Directive 2001/83/EC, as amended, Periodic Safety Update Reports (PSUR) will have to be submitted to Competent Authorities immediately upon request or at least every six months after authorisation and until the placing on the market.
PSURs will also have to be submitted immediately upon request or at least every six months during the first two years following the initial placing on the market and once a year for the following two years. Thereafter, the reports will be submitted at three-yearly intervals, or immediately upon request. Will there be a change of the PSUR cycle for medicinal products authorised before 30 October 2005?

For medicinal products not yet renewed before 30 October 2005, the current PSUR cycle will be maintained until the renewal. Thereafter, PSURs should be submitted at three-yearly intervals, unless other requirements have been laid down as a condition of the marketing authorisation.
For medicinal products not yet renewed before 30 October 2005, which have been granted a PSUR waiver or amendment of the PSUR-cycle (i.e. generics) the next PSUR should be submitted no later than three years after the implementation of the new legislation.
For medicinal products already renewed before 30 October 2005, the next PSUR should be submitted no later than three years after the implementation of the new legislation, as follows:
• For medicinal products for which the next renewal will be submitted within three years of 30 October 2005, the next PSUR should be submitted with the renewal application and thereafter at three-yearly intervals, unless other requirements have been laid down as a condition of the marketing authorisation.
• For medicinal products for which the next renewal will be submitted more than three years from 30 October 2005, a PSUR should be submitted within three years i.e. before 30 October 2008. The date of submission of the next PSUR should be agreed with the reference Member State. Thereafter, PSURs should be submitted at three-yearly intervals, unless other requirements have been laid down as a condition of the marketing authorisation. MAHs may ask for an early renewal to achieve that the submission of a PSUR coincides with the renewal application.
For medicinal products that are currently not marketed, once the product is placed on the market, the PSUR should be submitted at least every six months during the first two years of marketing and once a year for the following two years thereafter, unless other requirements have been laid down as a condition of the marketing authorisation. Subsequently, the PSURs should be submitted at three-yearly intervals or immediately upon request.

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PSURs submission

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Question 2
How will the PSUR submissions be managed if the time of marketing differs between the Concerned Member States?

Once the medicinal product is marketed in the EU, the PSUR submission cycle is based on the date of launch, for the first time, in any MS.
If the product was marketed in one MS first the rest should follow that PSUR submission cycle independently if the product was marketed at a later point or even not at all in other Member States. This in order to make the handling of PSURs feasible for all parties and to keep PSUR submissions harmonised (See also Volume 9 - Part I: Guidelines for MAHs).

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