Questions and Answers on the EU Synchronisation of PSUR submission schemes of medicinal products authorised through national, mutual recognition and decentralised procedures, rev1, 21-02-2007
Under the auspices of the “Heads of Medicines Agencies” an initiative has been taken to ensure that medicinal products with the same active substance follow the same Periodic Safety Update Report (PSUR) submission scheme in all EU Member States. The consolidated list of adopted EU Harmonised “virtual” Birth Dates (HBDs) and accompanying DLPs for the forthcoming PSURs, dated 7 February 2007, can be found on the HMA website (follow this link)
- 1. When can companies start to submit PSURs based on the EU HBDs?
- 2. Where should PSURs be submitted?
- 3. How should PSURs be submitted?
- 4. How should it be indicated that a PSUR is based on an EU HBD?
- 5. It may be difficult for the National Agencies to identify a certain generic product as being the same as a generic product in another member state and therefore it may be problematic to be sure whether a PSUR for a certain generic product is the same as submitted in other member states. How can marketing authorisation holders of generic products help National Agencies to identify unequivocally PSURs for generic products?
- 6. How should the reference information used in PSURs for products based on EU HBDs be presented?
- 7. At the time of publishing the list of EU HBDs and related DLPs several of the agreed DLPs have elapsed already for more than 60 days. Do Member States accept PSURs with a longer period than 60 days between DLP and submission date?
- 8. If PSURs have been submitted in the past on different dates because of different national birth dates, the first PSUR based on the EU HBD and related DLP will have an overlap with some PSURs that were submitted previously. Is that acceptable?
- 9. Should the EU HBDs also be used for PSURs for generic products?
- 10. Which reference safety information is to be used in PSURs for generic products based on EU HBDs?
2. Where should PSURs be submitted?
PSURs should be submitted simultaneously only in Member States were the product is authorised.
3. How should PSURs be submitted?
The distribution requirements and address lists for PSURs are given in an annex to Vol,9A. Where it is indicated that a PSUR should be submitted on CD-ROM it is meant that the PSUR should be submitted in two formats: PDF + WORD.
4. How should it be indicated that a PSUR is based on an EU HBD?
The cover letter and cover page of the PSUR should mention that the PSUR is based on a EU HBD and should also mention the P-RMS (Member state in charge of making the assessment report)
5. It may be difficult for the National Agencies to identify a certain generic product as being the same as a generic product in another member state and therefore it may be problematic to be sure whether a PSUR for a certain generic product is the same as submitted in other member states. How can marketing authorisation holders of generic products help National Agencies to identify unequivocally PSURs for generic products?
With the submission of the PSUR for a certain generic product the MAH should provide on an annex (table format) to the PSUR an overview of:
a. in which member states the relevant product is authorised,
b. under which product name,
c. the name of the marketing authorisation holder,
d. national licence number(s) and
e. MRP procedure number(s) where applicable.
6. How should the reference information used in PSURs for products based on EU HBDs be presented?
The Company Core Data Sheet (CCDS) should be presented in an SPC format, the assessment of which will focus on the safety aspects.
7. At the time of publishing the list of EU HBDs and related DLPs several of the agreed DLPs have elapsed already for more than 60 days. Do Member States accept PSURs with a longer period than 60 days between DLP and submission date?
Member States have agreed to accept PSURs that are submitted more than 60 days after the harmonised DLP. Addendum PSURs may be added if considered appropriate, however, also in that case the following PSUR should have a DLP which is 3 years after the original agreed harmonised DLP.
8. If PSURs have been submitted in the past on different dates because of different national birth dates, the first PSUR based on the EU HBD and related DLP will have an overlap with some PSURs that were submitted previously. Is that acceptable?
Yes, it is. It is inevitable that the first PSUR based on the EU HBD has an overlap with one or more PSURs submitted nationally in the past.
9. Should the EU HBDs also be used for PSURs for generic products?
It is strongly recommended that the EU HBDs and related DLPs are also used for the preparation of PSURs for generic products as there are considerable benefits associated with this harmonised approach. It may be advantageous to collaborate with other companies when preparing PSURs (see also Vol 9.9A, I.6.2.3, second paragraph).
The PSUR submission scheme to be applied for newly authorised generic products should be agreed between the competent authorities and the marketing authorisation holder at the time of granting the marketing authorisation. The applicant should at this time clearly indicate that he wishes to participate in this work sharing initiative and adopt the EU HBD. The agreement includes whether an immediate start with 3-yearly PSURs is acceptable (see also Vol.9A, I.6.2.4.c).
10. Which reference safety information is to be used in PSURs for generic products based on EU HBDs?
The reference information to be used in the PSURs for generic products should consist of the common safety information that is included in all current SPCs of the concerned generic product, as authorised in the EU Member States at the time of data lock point. See also Q&A 6. In addition, a summary of the other safety information that was not included in all SPCs should be submitted. The Marketing Authorisation Holder should indicate in the PSUR which changes to the Reference Safety Information as used are considered necessary on the basis of the data examined in the PSUR.