Variation Worksharing Procedure
Published:
Changes
The worksharing procedure is mandatory for variations affecting more than one marketing authorisation (MA) from the same MA holder.
To ensure harmonised outcomes of variation applications across Member States, it is important that MA holders use the worksharing procedure when applicable. Nationally authorised medicinal products for human or veterinary use, may be included in a worksharing procedure together with products authorised through other procedures. The worksharing procedure can also be used for purely nationally authorised products from different countries.
How to submit a worksharing application?
If the worksharing procedure includes a medicinal product authorised through the centralised procedure (CP), the request for worksharing must be submitted to EMA. Please refer to guidance and templates available on the EMA website.
For human medicinal products authorised via the national procedure, the decentralised procedure (DCP), or the mutual recognition procedure (MRP) included in the worksharing, the CMDh Chapter 7 – CMDh Best Practice Guide on Variation Worksharing is applicable.
If the worksharing concerns veterinary medicinal products, the CMDv Best Practice Guide for Worksharing is applicable.
Are there any conditions for using the worksharing?
For the worksharing procedure to be applicable, there should be little to no need for extensive product-specific assessments of the individual medicinal products included in the worksharing procedure. Furthermore, all proposed changes must apply to all products included in the procedure. A harmonised dossier or a harmonised product information is not a prerequisite for using the worksharing procedure. However, the outcome of the proposed update should be the same for all the included products.
Line extensions cannot be included in a grouped worksharing.
For changes affecting the product information, when should the product information be submitted?
Medicinal products for human use
For type II worksharing procedures, only common product information (PI) should be submitted with the application. The national translations are subject to evaluation during the national phase after End of Procedure (EoP). Note: After EoP it is the applicant’s responsibility to submit national translations which are updated in line with the approved version of the common PI. One version where all changes are marked compared to the currently approved text in Word format, and a clean version in PDF format.
For type IB worksharing procedures, both common and national product information should be submitted with the application. The national translations are subject to evaluation during the procedure and the final version will be issued at EoP.
If all products included in the worksharing procedure are nationally authorised, there is no requirement to include common product information in the submission. Instead, all proposed changes must be clearly listed in the "present and proposed" section of the application form or in a separate annex.
Veterinary medicinal products
If the variation affects the Summary of Product Characteristics (SmPC), package leaflet (PL) and/or labelling, these must be submitted at the start of the procedure.
Will I receive a separate approval from the Norwegian Medical Products Agency (DMP) for a nationally authorised medicinal product included in a worksharing that does not affect texts?
No, a separate approval will not be issued by the Norwegian Medical Products Agency for nationally authorised products in these cases. A worksharing for variations that do not affect texts may be considered approved by the Agency when:
- the EMA opinion is available (if CP-authorised products are included), or
- the final decision from the RMS is available (if only MRP/DCP and NP products are included).
Choice of Reference Member State
A Letter of Intent (LoI) must be sent to the desired Reference Member State (RMS) no later than two weeks before the planned submission. See Sections 3 and 4 of CMDh’s Chapter 7 on worksharing for more information on selecting the RMS.
Requests regarding whether DMP can act as RMS for an upcoming worksharing procedure may be sent to MT@noma.no.