VII.C.9. Transition and interim arrangements

VII.C.9.1. Submission and availability of documents before the Agency’s repository is in place

The Agency shall, in collaboration with the competent authorities in Member States and the European Commission set up and maintain a repository for PSURs and the corresponding assessment reports so that they are fully and permanently accessible to European Commission, the competent authorities in Member States, the PRAC, the CHMP and the CMDh [REG Art 25a].

The repository shall undergo an independent audit before the functionalities are announced by the Agency’s management board [REG Art 25a].

As established in the transitional provisions introduced in Directive 2010/84/EU Art 2(7), until the Agency can ensure the functionalities agreed for the repository, marketing authorisation holders under the obligation to submit PSURs irrespective of whether the medicinal product is authorised in one or more Member States and irrespective of whether the active substance or combination of active substances is on the EU reference date list shall submit the PSURs to all competent authorities in Member States in which the medicinal products are authorised. For the substances or combination of active substances subject to the EU single assessment, and for which an EU reference date has been established, the PSURs should be also sent to the Agency.

The competent authorities in Member States requirements for the submission of PSURs during this transitional period are published in the Agency web-site25.

From 12 months after the functionalities of the repository have been established and have been announced by the Agency, the marketing authorisation holders shall submit the PSURs electronically to the Agency regardless of the authorisation procedure of the medicinal product [DIR Art 107b(1)]. The competent authorities in Member States shall ensure that this obligation applies as required [DIR Art 2(7)].

Once the structured electronic format “ePSUR”, based on content agreed in the ICH-E2C(R2), becomes available, marketing authorisation holders will have the possibility to submit PSURs and related documents automatically via an electronic gateway.

Until the repository is in place, the relevant documents should be circulated as follows:

• The preliminary assessment report created by the PRAC Rapporteur/Member State within 60 days of the start of the procedure should be circulated to the Agency and the members of the PRAC through a dedicated mailbox. The Agency should send the report to the concerned marketing authorisation holder(s);
• members of the PRAC should circulate their comments through a dedicated mailbox by Day 90 on the PRAC Rapporteur/Member State preliminary assessment report;
• comments by the marketing authorisation holders(s) by Day 90 on the PRAC Rapporteur/Member State preliminary assessment report, should be submitted to the Agency, PRAC Rapporteur and all members of the PRAC, according to the instructions for submission published by the Agency;
• updated PRAC Rapporteur/Member State assessment report created within 15 days (i.e. by Day 105) should be circulated to the Agency and members of the PRAC through a dedicated mailbox. The Agency should forward the updated PRAC Rapporteur/Member State assessment report to the marketing authorisation holders concerned.

Further to adoption, the Agency should send the CHMP opinion together with its annexes and appendices to the European Commission, marketing authorisation holder(s) and competent authorities in Member States, through secure email until the repository is in place.

VII.C.9.2. Quality systems and record management systems at the level of the competent authorities in Member States

Special considerations should be taken for the management of the PSURs submitted to the concerned competent authorities in Member States until the Agency can ensure the functionalities agreed for the PSUR repository and 12 months after the establishment of the repository according to the transitional provisions.

VII.C.9.3. Publication of the EU list of union references dates and start of the EU- PSUR single assessment procedure

As stated in VII.C.3.6., the list of EU reference dates and frequency of submission should be published in the European medicines web-portal, nevertheless, the EU single assessment procedure for substances included only in nationally authorised products, detailed in VII.C.4.2.2., and VII.C.4.2.4. will be delayed until funds are available.