Implementation of variations to marketing authorisations
Type IA and IAIN variations
Applications for type IA variations have to be submitted within no more than 12 months after the implementation, or it is possible to implement the variation to marketing authorisation within 6 months of the anticipated acceptance of the variation; the specific date of the implementation shall be always stated in the application form for the variation to marketing authorisation.
Applications for type IAIN variations have to be submitted immediately after their implementation (within approx. 14 days), or it is possible to implement the variation to marketing authorisation within 3 months of the anticipated acceptance of the variation; the specific date of the implementation shall be always stated in the application form for the variation to marketing authorisation.
The aforementioned shall be applicable also to type IA/IAIN variation groupings.
Where the applications for type IA and IAIN variations are submitted later that within the periods specified above (i.e. later than within 12 months after the implementation in case of type IA variations or immediately after the implementation of type IAIN variations), it is necessary to submit them as type IB variations to marketing authorisations, as the conditions for type IA or IAIN variations are not met.
The date of the implementation in the application form shall be stated directly with the selected classification of the variation in the “Implement. Date” field. Where applications for MRP variations are concerned, the specific date of the implementation applicable to the Czech Republic may be provided in the “Implement. Note” field along with an explanation that this information applies to the Czech Republic. Only in case a type IA variation is part of a type IB or II grouping and its implementation depends on the approval of other variations within the concerned grouping, it is possible to specify the same implementation as that for a type IB or II variation (see below).
In case an application for a type IA or IAIN variation that has already been implemented is submitted, but in the course of assessment the texts are amended, it is not possible to wait with the implementation of such amendment until the approval of another variation to marketing authorisation. Such amendment should be implemented as soon as possible, i.e. upon the next production run/next printing. The same course of action is to be applied also in case of rejection of such variation to marketing authorisation, as, pursuant to Article 24 of Commission Regulation (EC) no. 1234/2008, as amended by Commission Regulation (EU) no. 712/2012, the marketing authorisation holder shall cease to apply the concerned variation immediately after receipt of such information.
Type IB, II, and P variations
In the application forms for type IB, II (incl. type IB or II groupings) and P variations (national as well as MRP variations to the labelling or the PIL, not associated with the SmPC), these terms shall be specified in the “Declaration of the Applicant - Change(s) will be implemented from” field:
- Next production run/next printing or
- Date: state a specific date or a statement such as “within 6 months after approval”
Next printing run – this concerns only text variations, not affecting another part of the dossier. The variation is implemented upon the printing of the new texts (or at least one type of the text in case of variations to both labelling and PIL).
Next production run – the scope of variations is more extensive (it may concern also variations affecting texts). The variation is implemented upon the start of production in compliance with any part of the dossier approved within the scope of the variation to marketing authorisation.
Statement “within 6 months after approval” = the latest timeline for the implementation of the variation; the variation has to be implemented any time until this date (6 months after the approval of the variation).
Where applications for MRP variations are concerned, the specific implementation for the Czech Republic may be provided in the text field under the “Date” field along with an explanation that this information applies to the Czech Republic.
Implementation of variations to marketing authorisations associated with the manufacture of the medicinal product
The variation is implemented upon the start of the production run/printing performed “in the new way” (i.e. in compliance with the approved variation to marketing authorisation). Until the date of the implementation, the medicinal product has to be released “in the old way” (i.e. pursuant to the dossier valid prior to the approval of the concerned variation to marketing authorisation). Nevertheless, as soon as the variation is implemented (= the start of the production performed “in the new way”), the medicinal product may no longer be released “in the old way”, as following the implementation, the medicinal product may only be released “in the new way”. It is not permissible to release both versions of the medicinal product in parallel and, equally, it is not permissible to release the product “in the new way” and “in the old way” in parallel; it is necessary to separate the production “before” and “after” the implementation of the concerned variation to marketing authorisation.
Note: The process of medicinal product batch release is a manufacturing step, the requirements are stipulated by guideline VYR-32 Amendment 16 – Certification by qualified person and batch release, as last amended.
Implementation of marketing authorisation renewals
The implementation date is not specified in the application form for the MA renewal. The implementation occurs on the date when the decision on the MA renewal comes into force. This means that prior to the decision on the MA renewal comes into force, the medicinal product has to be released “in the old way” (i.e. pursuant to the dossier valid prior to the approval of the MA renewal); when this decision on the MA renewal comes into force, the manufacture (i.e. the next production run/next printing), incl. release, has to be performed “in the new way” (i.e. in compliance with the approved MA renewal).
Implementation of marketing authorisation transfers
In the application form for the MA transfer, the implementation shall be stated in the “Date when transfer should become effective” field by selecting from the list of options available, as the MA transfer is implemented upon the date when the MA transfer becomes effective (i.e. when the decision on the MA transfer comes into force or as of a specified future date).
Marketing authorisation transfers implemented as of the date when the decisions on the marketing authorisation transfer come into force
The implementation occurs on the date when the MA transfer decision comes into force. This means that prior to the MA transfer decision comes into force, the medicinal product has to be released “in the old way” (i.e. pursuant to the dossier valid prior to the approval of the MA transfer); when this decision on the MA transfer comes into force, the manufacture (i.e. the next production run/next printing), incl. release, has to be performed only “in the new way” (i.e. in compliance with the approved MA transfer).
Marketing authorisation transfers implemented on a future date
The implementation occurs on the future date when the MA transfer becomes effective (which is specified also in the decision on the MA transfer). This means that prior to the specified future MA transfer date, the medicinal product has to be released “in the old way” (i.e. pursuant to the dossier valid prior to the approval of the MA transfer); after the future MA transfer date, the manufacture (i.e. the next production run/next printing), incl. release, has to be performed only “in the new way” (i.e. in compliance with the approved MA transfer).
Information on the final sale of medicinal products following the approval of the variation to marketing authorisation, renewal and transfer of marketing authorisation are provided on SÚKL's website.
Marketing Authorisation Section
10 April 2014 (update of 5 November 2021)
cz