In case a MA Transfer is sought for several medicinal products, a common data package may be prepared but an application must be submitted for each MA (i.e. 1 application per product). We offer a national assessment procedure for UK-wide marketing authorisation (MA) applications. Guidance on the MHRA’s national assessment procedure for marketing authorisation applications.
- Such compliance check consists of verifying that the fulfilments of the measures as mentioned in the PIP decision including the timelines for the conduct of the studies or collection of the data are fulfilled.
- These variations will be processed to conclusion using the same procedures that were in place prior to 1 January 2021 (refer to Section 2).
- You must include the appropriate legal basis for your application when you apply to MHRA for a marketing authorisation.
We will publish a refusal PAR once any appeal process is concluded, unless you withdraw the MA application before we make our final decision. We will only refuse an MA application after receiving the final advice of the CHM (see section 2.6), except when you have not responded to a RFI within the required timeframe. Following authorisation of a NAS, we will publish a press release within one week and a PAR within 30 days. If we decide that your application is approvable, we may implement a third RFI round (as described in section 2.5) before we conduct final compliance checks and grant your application. We will consider the final advice of the CHM and proceed to grant or refuse your MA application (and orphan designation application where relevant). If you decide to make representations in relation to orphan designation, we will defer our decision on the MA application until the representation process is complete.
When do I have to submit revised product information? In all languages? Rev. October 2024
The new MAH (transferee) is responsible for all released batches. The Transferee becomes the new MAH and the product contact of EMA for further regulatory activity. The Transfer application should include information as to the date on which the Transferor will release the last produced batch in the distribution chain, duly justifying why that particular date has been chosen. This date is proposed by the Transferor and Transferee in the Transfer application, attachment 2, and will be subject to agreement by the EMA. In any case finalisation of the opinion should be within 30 days upon receipt of the Transfer application. Upon receipt of the applicant responses the Agency aims to finalise the procedure by Day 20.
7 Decision
Product information includes the summary of product characteristics, leaflets and labels. Additionally, include a copy of the approval email from CEC in the application. Applicants should reference the grouping approval in both the cover letter and application form. Should the Type IA variation be dependent on other changes in the group and the group is rejected, implementation of the Type IA change would have to cease. For example, a change to the manufacturing site of the finished product, change in batch size and the manufacturing process to a single product. Multiple changes to a single product can be made using the ‘grouping’ format, if the changes are directly related.
Under which procedure should I submit my PAM? Rev. Nov 2025
A letter of consent confirming permanent access of the applicant to the data supporting the already authorised product for the purpose of an informed consent application and possession of Module 3 of the data is required. A marketing authorisation holder may permit another marketing authorisation applicant to make use of their pharmaceutical, pre-clinical and clinical documentation to obtain a marketing authorisation. Information such as public assessment reports published by competent authorities and any published information still within a data protection period cannot be used as evidence to support a well-established use application. The biosimilar medicinal product cannot be authorised for different or more extensive indications than those authorised for the reference medicinal product.
For specific advice on a proposed product name, you should contact When a UK PIP compliance check is required, you should submit the request at least 60 days before the planned submission date for your MA application. We will come to a final decision on established medicines applications within 210 days. These are defined as applications that do not meet the innovative medicines application criteria outlined above.
How to apply (all variation types except extensions)
If you do not submit a complete response within 3 months, we will notify you that we propose to refuse your application. There are no fixed submission dates for your responses to the second RFI. We biatch will restart the clock 3 calendar days after the response submission deadline. If you do not submit a complete response within 6 months, we will notify you that we propose to refuse your application.
A Transfer application follows a 30-day procedure following receipt of the application. EMA expressly disclaims any liability or accountability for the presence of unnecessary personal data in the annotated PI submitted by the MAH. The annotated product information files must include the statement containing the procedure number(s) and may be published on the EMA website as part of the product EPAR page.
How should I structure my PAM submission dossier?
EMA will endeavour to provide such feedback as soon as possible and taking into consideration the launch plan of the medicinal product, as applicable. In case of comments on the specimens, the MAH should submit responses and/or updated mock-ups, as applicable, to the EMA () prior to the launch of the medicinal product. EMA will endeavour to provide such feedback as soon as possible and taking into consideration the production plan of the medicinal product, as applicable. If such PAMs are still remaining for the medicinal product concerned, it is the responsibility of the Transferee to fulfil them within the timeframe previously agreed. MAHs should avoid submitting variation procedures in parallel to a Transfer of MA application.
In this case, if previously only a justification was submitted, the MAH/sponsor will be requested to provide a maintenance report. The justification/ maintenance report should be submitted via the IRIS Platform. Please note that if the Agency identifies a possible similarity issue not addressed by the applicant before validation, the applicant will be asked to complete the application with information on similarity and, if applicable, on one of the derogations. Alternatively, MAHs may request a pre-submission meeting with the Agency to clarify any outstanding points. For queries related to the presentation of the application, please contact the Agency. It should be noted that the responsibility for the quality of the submitted documentation lies with the MAH and is crucial to the overall process.
How, when and to whom shall I submit my extension application?
The Agency will send to the MAH the final assessment report after CHMP adoption. The Agency will check PAM submissions with respect to the Guidelines on Variations to ensure that it does not fall within one of the classifications. (SDA when related to a signal assessment, otherwise LEG)
In such situations, the rapporteur (or a lead rapporteur nominated by the committee in case of more than one affected product) may draft an assessment report on the impact of the lack of data on the benefit/risk balance of the affected product or other analysis to support a discussion on the next steps by the Agency’s committee(s). Most PAMs will be evaluated by CHMP (and CAT if an advanced therapy medicinal product). Where the MAH is requested to resubmit as a variation application, the start of the variation procedure will be upon receipt of the complete application according to the next upcoming starting date as per published timetable for Type II.
Post-authorisation measures: questions and answers
- Applicants for a UK-wide MA for a generic medicinal product may omit from their application the results of pre-clinical tests and of clinical trials if the product can be shown to be a generic of a reference medicinal product (RMP) which is or has been authorised in the UK for not less than eight years under regulation 49(1)(a).
- Only in case the transfer has an impact on the overall design, relevant revised example specimens should be provided to the EMA by the new MAH, in line with the requirements for new applications and extensions
- For further information or guidance on creating an EMA Account, please refer to the guidance “Create an EMA Account” guidance.
- EMA will endeavour to provide such feedback as soon as possible and taking into consideration the production plan of the medicinal product, as applicable.
The MAH shall submit the Extension application in accordance with the recommended submission dates published on the Agency website (see “submission deadlines and full procedural timetables”). To support this process, the MAH/sponsor is requested to provide at the time of submission of the application either a justification that the application does not raise doubts on the fulfilment of the orphan criteria or a maintenance report to justify that the orphan criteria are still met. Validation of the application will only proceed once the applicant has submitted either a report justifying the lack of similarity or information justifying one of the derogations in Article 8(3). If significant differences exist within one or more of these criteria, the two products will not be considered as similar.
For the Transfer of a Marketing Authorisation covering medicinal products already marketed in the EU/EEA by the Transferor, the proposed date should be set taking into account the following timelines (see also “Transfer of Marketing Authorisation – How shall my Transfer of Marketing Authorisation application be handled (timetable)? 6) When the name of a product is composed of ‘INN + company name’ please see Transfer of Marketing Authorisation – “Can I change the name of a medicinal product as part of a transfer application? This includes confirmation that the complete and up-to-date file concerning the medicinal product or a copy of this file, including any data/documents related to the paediatric obligations, has been made available to or transferred to the Transferee.
If the MAH is unable to provide the required data by the specified deadline, he must inform the Agency and the rapporteur in writing as early as possible in advance of the due time of submission. Data submitted as PAM should be submitted as per the deadline specified by the Committee(s), and will start in accordance with the published submission dates for PAMs (see also Human Medicines – Procedural timetables / Submission dates). The MAH shall submit the PAM data according to the timeframe specified by the Agency’s committee(s) as specified either in the annex II, the RMP or the respective committee assessment. Such reclassification will be performed within the procedure discussing the impact of the new information that has become available and will be justified in the assessment report where the measure is, as a consequence, up- or downgraded.
The filled-in checklist should be submitted as part of the Extension Application dossier. The information will be used for planning purposes by the Agency and the Rapporteurs’ assessment teams. In case of doubt, the MAH is advised to contact the Agency in advance of the submission. This page provides an overview of the European Medicines Agency’s position on issues that are typically addressed in discussions or meetings with MAHs in the post-authorisation phase.
Guidance
Furthermore, when planning submission of their marketing authorisation application, the applicant has to take into account also the need for a “PIP” compliance check to be done. Information on opinions on extension applications is not given in the meeting highlights following each CHMP meeting, unless they are grouped with a type-II variation in relation to new indications, changes to an existing indication, addition, change or removal of a contraindication. At the time of the adoption of a CHMP opinion for an extension application that includes additional presentations, the Agency will assign new EU sub-numbers and include them in the revised annex A of the medicinal product, which will be transmitted to the MAH together with the CHMP opinion and respective annexes. EMA expressly disclaims any liability or accountability for the presence of unnecessary personal data in the annotated PI submitted by the marketing authorisation holder. It is possible for an MAH to group extensions with other variations submission (e.g. type-II, -IB or -IA variations), where applicable. In any case, the Agency will check at certain milestones of the procedure, i.e. adoption of list of questions, request for supplementary information and prior to adoption of a CHMP opinion whether new orphan medicinal products have been authorised for the same condition.
This section only applies to submissions of PAM data as a ‘stand-alone’ submission. Information is available on ‘Submitting a post-authorisation application’. The MAH does not need to submit a separate ‘stand-alone’ submission of the PAM data. The PAM submission form does not need to be included in the variation submission package.
Relating to circumstances where comprehensive clinical data referring to the safety and efficacy of the medicinal product have not been supplied; Regulation 50 requires the applications to be supported by comprehensive pharmaceutical, non-clinical, and clinical data as set out in Schedule 8 of the HMRs in order to demonstrate that the product has a positive balance of benefit to risk in the indications claimed for. You must include the appropriate legal basis for your application when you apply to MHRA for a marketing authorisation. If you do not wish to do so, please ensure that the individuals whose data is included consented to its sharing with EMA and its further sharing by EMA with third parties such as other marketing authorisation applicants, marketing authorisation holders and National Competent Authorities, as relevant. Please refer to question ‘Can a new indication based on less comprehensive data be added to an already authorised medicinal product? The critical report provided in Module 1.7.1 should address the possible similarity between the proposed new medicinal product and the authorised orphan medicinal products for each of these criteria.