PERIODIC SAFETY UPDATE REPORT (PSUR) REPOSITORY MANDATORY USE
We inform marketing authorisation holders for medicinal products for human use that, from 13 June 2016, they are required to submit Periodic safety update reports (PSUR) to the PSUR repository, set up by the European Medicines Agency (EMA) for the entire EU. Agency for Medicinal Products and Medicinal Devices of the Republic of Slovenia (JAZMP) will therefore no longer accept PSUR delivered directly to the address of the agency.
PSUR SINGLE ASSESSMENT (PSUSA)
For medicinal products which contain active ingredients (or combinations of active ingredients) from the list of EU reference dates and frequencies for submission of PSURs (EURD list), the EU PSUR single assessment (PSUSA) is performed. Conclusions of PSUSA procedures are compulsory for Marketing authorisation holders.
Conclusions of PSUSA procedures:
- which include active ingredients only contained in centrally authorised products, are published in the European Public Assessment Report (EPAR) for the medicinal product in question (link);
- which include active ingredients contained in centrally authorised products and in nationally authorised products, are published in the medicinal products register run by the European Committee (Community register);
- for active ingredients contained in purely nationally authorised products, are published on the European Medicines Agency website (link and/or https://www.ema.europa.eu/en/medicines/what-we-publish-medicines-when => Table 20 ). Publication includes the list of medicinal products in question and, when a variation of the marketing authorisation follows from the procedure, the scientific conclusions (CMDh scientific conclusions and grounds for variation), schedule for implementing the amendment, and accompanying text regarding when information about the medicinal product must be updated (in all official EU languages). Marketing authorisation holders should regularly check for publications and whether the PSUSA conclusions concern their medicinal products (CMDh Press Releases), even if they were not directly included in the procedure (such as generic medicinal products and medicinal products authorised on the basis of well-established use or other pharmaceutical forms and medicinal products with the combination of active substances).
For more information, see
OVERVIEW OF EDUCATIONAL MATERIALS
JAZMP reviews and authorises educational materials which marketing authorisation holders prepare on the basis of Annex II of the Commision Implementing Decision and educational materials which the marketing authorisation holder must prepare on the basis of a Risk Management Plan.
For detailed instructions (last updated on 17 June 2021), see:
Published educational materials are accessible here.
DIRECT HEALTHCARE PROFFESSIONAL COMMUNICATION
A Direct Healthcare Professional Communication (DHPC) aims to deliver important safety information immediately and directly to healthcare professionals to inform them of a safety concern and specific measures or adjustments necessary for a given medicinal product to minimise the risk. DHPC is delivered by a marketing authorisation holder or by a competent authority. Before distribution, a marketing authorisation holder obtains the consent of the JAZMP regarding the content and format of the DHPC, communication plan including information on the way and timeframe of distribution and target groups.
For more information, see:
Instructions for submitting of Direct Healthcare Proffessional Communication (DHPC) to JAZMP
OBLIGATIONS OF MARKETING AUTHORISATION HOLDERS REGARDING SAFETY SIGNALS
The marketing authorisation holders must continuously monitor the data in EudraVigilance and report to the competent authority for detecting signals (EMA) about safety signals. They must also notify the competent authorities in member states where the medicinal product is authorised regarding safety issues which may arise from the safety signal and could significantly affect the benefit – risk balance of the medicinal product in question and/or have consequences for public health.
The European Medicines Agency publishes information on new safety signals discussed by the Pharmacovigilance Risk Assessment Committee (PRAC) in their agenda and in PRAC meeting minutes, and in text form.
Marketing authorisation holders should follow the EMA website regarding PRAC recommendations concerning safety signals.
For more information, see:
RISK MANAGEMNET PLANS
Risk management plan is part of dossier submitted when applying for a marketing authorisation and includes information on:
• a medicine’s safety profile;
• how its risks will be prevented or minimised in patients;
• plans for studies and other activities to gain more knowledge about the safety and efficacy of the medicine;
• measuring the effectiveness of risk-minimisation measures.
RMPs are continually modified and updated throughout the lifetime of the medicine as new information becomes available. For medicines that do not have an RMP, one may be required with any application involving a significant change to the marketing authorisation. In addition, for nationally authorised medicinal products, any national competent authority (NCA) in the EU can request an RMP whenever there is a concern about a risk affecting the benefit-risk balance of a medicine.
Summaries of RMPs for centrally authorised medicines are published by European Medicines Agency and are available on each medicine’s page (link).
For more information, see: Questions and answers on the RMP summary
The list of substances (medicines) for which safety concerns were assessed in the HaRP project (Harmonisation of RMP Project) or harmonised by PRAC is available on CMDh website.
LOCAL CONTACT PERSON FOR PHARMACOVIGILANCE
If not established in the Republic of Slovenia, the marketing authorisation holder may, in addition to the QQPV, appoint local contact person for pharmacovigilance. The MAH should notify JAZMP on the name and contact details and any later changes to this informarmation to the e.mail address: ."> .