SPC harmonisation
SPC harmonisation procedure
With the entry into force of Regulation (EU) 2019/6 a new procedure for harmonisation of the Summary of Product Characteristics (SPC) was created, as given in section 4 of this regulation.
The Coordination Group for Mutual Recognition and Decentralised Procedures for Veterinary Medicinal Products (CMDv) issued three Best Practice Guides for the selection of reference veterinary medicinal products (RVMPs) and for the process of the SPC harmonisation procedure, taking into account the requirements acc. to Articles 69 to 71 of Regulation (EU) 2019/6. The new SPC harmonisation procedure can be divided into three phases which are reflected by the 3 BPGs as follows:
Phase 1 – Selection phase of RVMPs:
Pursuant to Article 70 of Regulation (EU) 2019/6, the CMDv shall publish an annual list of RVMPs that shall be subject to the SPC harmonisation and to designate a reference member state (RMS) for the procedure of each RVMP concerned. Both the marketing authorisation holders and the competent national authorities of the member states (NCAs) may submit proposals for RVMPs to be harmonised.
Before the end of May of each year proposals can be submitted via a form made available by the CMDv, so that they can be considered when preparing the work plan for the coming year. For the submission of proposals and the decision on the selection of RVMPs, the criteria of the prioritisation list set out in the “BPG for the selection of products for SPC harmonisation” are used. The final list of RVMPs will be published annually by the CMDv.
- Proposals for RVMPs for SPC harmonisation shall be submitted by the marketing authorisation holder by May 31 of each year:
Please use the form as provided by the CMDv: link - The lists of RVMPs subject to SPC harmonisation adopted by the CMDv and HMA can be found on the CMDv-website: Link - adopted lists of RVMPs
Phase 2 – SPC harmonisation of RVMPs:
Following the selection process, the RMS shall contact the marketing authorisation holder of the RVMP that is subject to the SPC harmonisation in order to coordinate the course of this 180-day SPC harmonisation procedure and the Part II harmonisation if required. At the end of the SPC harmonisation process of the RVMP, the national marketing authorisation is transferred to an MRP status. For detailed information on the SPC harmonisation process of RVMPs in accordance with Article 70 of Regulation (EU) 2019/6, please see the “BPG for the harmonisation procedure of the SPC of the reference products”:
- Finalised SPC harmonisation procedures of RVMPs and their harmonised product information texts can are published on the CMDv website: Link - results of SPC-harmonisation of RVMPs
Phase 3 – SPC harmonisation of related generic and hybrid VMPs:
Subsequently, after national completion of the SPC harmonisation of the RVMP, the marketing authorisation holder of the associated generic/hybrid veterinary medicinal product shall submit a variation in accordance with Article 62 within 60 days in order to adapt the SPC according to Article 71 of Regulation (EU) 2019/6. For detailed information please see “BPG for the harmonisation procedure of the SPC of generic/hybrid VMPs”.
The current product information of the RVMP can be found in the Austrian medicinal product index in German, as published by the BASG.
For SPC harmonisation of your generic or hybrid veterinary medicinal product, please contact rms@basg.gv.at as soon as possible to arrange a suitable timetable for this procedure. To do so, announce all text changes affected in accordance with Article 71 of Regulation (EU) 2019/6 in order to apply for them as “grouped” variations.
For example:
- G.I.2.b (Harmonisation of the generic/hybrid product according to Article 71(1) after SPC harmonisation of the reference product)
- I.III.1.a) (Change or addition of target species)
- G.I.12 (Changes to the withdrawal period for a VMP)
- G.I.18 (One-off alignment of the product information with version 9.0* of the QRD templates)
Further information:
