If the active substance is not included in the EURD list, a MAH is still obliged to keep submitting the PSUR in accordance with the frequency, specified in the marketing authorisation or if it is not specified therein, then in compliance with law (6-month, annual, 3-year frequency).
It is not necessary to apply for the marketing authorisation variation in relation to these medicinal products, the Amendment to the Act on Pharmaceuticals itself has nullified the obligation to submit the PSUR, specified in the marketing authorisation of these medicinal products.
For products with hybrid marketing authorisation it is necessary to submit the PSUR. If for example it concerns a product which has two different strengths, where one has hybrid marketing authorisation and the other one generic, the PSUR will relate to hybrid strength, plus cases when it is not certain what strength is concerned.
If the EURD list does not specify a fixed combination and the product does not fall under the category of products exempt from the submission of the PSURs, a MAH should continue submitting the PSUR according to the frequency and the DLP, specified in the marketing authorisation, or if it is not stipulated therein, then in compliance with law.
Until the PSUR database in the EMA becomes functional, marketing authorisation holders are to send PSURs to the national agencies. PSURs shall start to be sent to the EMA not before 12 moths after the functionality of the PSUR database has been announced.