The nature and extent of supporting data must consider the prevalence of the condition to be treated, the time over which the substance has been used, quantitative aspects of the use including geographic spread and degree of scientific interest and the coherence of scientific assessments. The definition of the RMP and the period of data exclusivity and market protection apply as in the case of a generic application. Generic applications are based on a derogation from the requirements for a full application. Guidance on licensing of ATMPs in UK including the classification of products falling within the definition of an ATMP. Requirements and rewards for products that have been developed to treat rare diseases. The products may not be marketed until a further period of market exclusivity has expired.
Submission of duplicates of products with Northern Ireland as a Concerned Member State should consider guidance applicable in the EU. These must be identical to the first application or authorisation except for the product name of the duplicate which (if an invented name) must be different from the product name of the first product. Applications through the UK Homeopathic National Rules Scheme can be made for any homeopathic medicinal product which meets the definition of a homeopathic medicinal product given in the Human Medicines Regulations and does not satisfy the requirements of the Simplified Homeopathic Registration Scheme (Regulation 103 of the HMRs).
A biosimilar application can be made for a biological medicinal product which cannot meet the definition of a generic medicinal product owing to differences relating to raw materials or differences in manufacturing processes when compared to the reference medicinal product (RMP). Where the UK RMP is a converted Union authorisation (a centrally authorised product (CAP)), the data and market exclusivity period which was in effect on 31 December 2020 will apply unless market exclusivity has been subsequently extended through an application direct to MHRA. A hybrid application for a medicinal product can be made when the active substance is the same as that in a reference medicinal product but the strict definition of a generic medicinal product is not met. Where the UK RMP is a converted Union authorisation (a centrally authorised product (CAP)), the data and market exclusivity period which was in effect on 31 December 2020 will apply unless market exclusivity has been subsequently extended through an application direct to MHRA (refer to section 4) Indications can be amended subsequently through a post-authorisation variation application supported by relevant data. At the time of authorisation, a generic medicinal product cannot be authorised for different or more extensive indications than those authorised for the reference medicinal product.
ECTD (Electronic Common Technical Document) format is mandatory for submissions. Applications must be submitted via the MHRA Submissions Portal using the appropriate template. This extension is only awarded once even if further new indications are authorised. A duplicate application is not defined in the Human Medicines Regulations. Further guidance has been published in The UK Homeopathic National Rules Scheme. Further guidance has been published in Register a homeopathic medicine.
Variations to MAs where Northern Ireland is a Concerned Member State
Further details on the format, timing and content of PIP or waiver applications as well as on the compliance check can be found in the Commission guideline. Further information can be found in the Procedural advice on paediatric applications,which is available on the Agency’s website under ‘Paediatric medicines’. The MAH should include the newly assigned numbers in all language versions of annex A and in all applicable sections of the product information, which are submitted following the CHMP opinion for linguistic review.
Under which procedure should I submit my PAM? Rev. Nov 2025
A Transfer of MA does not include a Transfer of Orphan designation since this is subject to a different procedure (see also “Do I also have to transfer the Orphan designation when my medicinal product has been granted such a designation?”). From January 2025, marketing authorisation holders should use the IRIS platform when managing transfers of marketing authorisation after the original submission. To be clear which applicable laws apply for UK authorisations, medicinal products will be assigned to Category 1 or Category 2.
How shall I present my extension application? Rev. Nov 2025
- The reason for the delay must be justified and a new submission date proposed and is subject to agreement by the Committee(s).
- You can find out more at Register to make submissions to the MHRA.
- These questions and answers have been produced for guidance only and should be read in conjunction with the rules governing medicinal products in the European Union, volume 2, notice to applicants.
- This section only applies to submissions of PAM data as a ‘stand-alone’ submission.
- Only certain medicinal products can be subject to specific obligations (see also ‘What is a Specific Obligation?’).
- An application through the simplified registration scheme can be made for homoeopathic medicinal products which meet the definition of a homeopathic medicinal product given in the Human Medicines Regulations.
Information such as public assessment reports published by competent authorities and any published information still within a data protection period cannot be used for this purpose. Supporting data may be all original data generated by, or for, the MA applicant (referred to as a full application) or it may be a combination of original data and information available in the public domain (referred to as a mixed application). Refer to section 4 on circumstances where extensions to the periods of data protection or market exclusivity may be permitted.
Such grouped submissions will follow the review procedure of the highest variation in the group. The assessment includes the consultation of the Quality Working Party or the Biologicals Working Party for the aspects concerning the similarity of the molecular structures of the products. The assessment of similarity is conducted in parallel to the evaluation of the extension application and follows the same timetable. (c) the applicant can establish that their product, although similar to the orphan medicinal product already authorised, is more effective, safer or otherwise clinically superior, in which case a critical report justifying clinical superiority to the authorised product must be provided. The CHMP co-rapporteur is normally not involved in the assessment of an extension application.
Can a new indication based on less comprehensive data be added to an already authorised medicinal product?
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 will my variation application be considered a type II variation or an extension application?
’ and ‘Do I need to address any paediatric requirements in my extension application? The above requirements also apply to the submission of the validation checklist for Extension application(s) and the responses to List of Questions / List of Outstanding Issues. This can be achieved by means of an email to the Product Lead, , , the Rapporteur, Co-Rapporteur and, if applicable, PRAC Rapporteur, summarising the scope of the intended application and specifying the target submission date.
MA applications via the Access Consortium NASWSI are subject to a different timetable (see section 2.8 for more details). We encourage you to complete the factual sections of the MHRA clinical assessment report template, to facilitate a streamlined assessment procedure. Our data requirements depend on the legal basis of your MA application under the Human Medicines Regulations 2012 (as amended) (HMRs).
How shall my transfer of marketing authorisation application be handled (timetable)? Rev. Jul 2021
European Medicines Agency post-authorisation procedural advice for users of the centralised procedure This allocated PM will be the contact point for this procedure. To help us deal with your enquiry, please provide as much information as possible including the name of the product in your correspondence. For further information or guidance on creating an EMA Account, please refer to the guidance “Create an EMA Account” guidance. The European public assessment report (EPAR) will also be revised to implement the change in the MAH.
Requests for updates of the product information should be addressed via a variation; a scientific justification for not submitting a requested variation should be submitted as a PAM. Information not impacting on the product information or description/due date of the measure itself, (e.g. interim results) , can be submitted as a self-standing PAM as described in question How and to whom shall I submit my PAM data?. Once additional pharmacovigilance activities have been agreed within the RMP, changes to these measures (e.g. proposals for adjusting due dates of agreed milestones, proposals to change the scope of agreed study or its duration, etc.) should be submitted via the appropriate variation procedure to amend the RMP. Additional pharmacovigilance activities in the RMP (category 3 studies) may be non-clinical studies, clinical trials or non-interventional studies which are required to investigate a safety concern of a medicinal product. Final results leading to the fulfilment of the Annex II condition should be submitted as a variation application.
Note the UK position on changes to Covid vaccines explained in section 7 of this guidance. The application process to apply for a new MA will need to be followed. Deficient or incorrect documentation can lead to invalidation and/or rejection of the variation. With a period for the applicant to respond to any requests for further information (RFIs) necessary to reach a decision, assessment timeframes become 30, 90 and 120 days respectively. Once MHRA has all the documents, it will take 22-days, (reduced timetable), 60-days (standard timetable) or 90-days (extended complex timetable) to assess the application depending on how urgent or complex the changes are, excluding time taken to answer questions. One example of a major change is adding a new therapeutic indication to a product or updating the current indication.
For information concerning submission of mock-ups and specimens in the framework of extension applications, please refer to Checking process of mock-ups and specimens of outer / immediate labelling and package leaflets of human medicinal products in the centralised procedure, 3.1 new marketing-authorisation applications and extension applications. In advance of submission of your application for an extension of your marketing authorisation, irrespective of whether your medicinal product has been designated as orphan or not, you are advised to check the Community register of orphan medicinal products, for information on medicinal products designated as orphan. Any changes to the product that require a marketing authorisation extension application should be submitted in accordance with the procedures for new marketing authorisations. Any medicinal product which belongs to the global marketing authorisation is treated for the purposes of the application for generic, hybrid or biosimilar products as if it had been authorised on the date of authorisation of the medicinal product to which the initial marketing authorisation relates. Applications submitted to MHRA for a marketing authorisation for a medicinal product must state the legal basis under which the application is made.
- If your response is incomplete or does not resolve the issues raised on quality, safety, or efficacy, we will refer the application to the CHM for advice on refusal.
- Different requirements, procedures and timelines apply for MA applications via the International Recognition Procedure (IRP).
- However, assessment reports for data submitted in accordance with Article 46 of the Paediatric Regulation and PRAC recommendations on signals are published on the Agency’s website.
- The application process to apply for a new MA will need to be followed.
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.
Within 7 days upon receipt of the Transfer application, the EMA will check whether the Transfer application is correct and complete. English and multi-lingual (‘worst-case’) colour mock-up of outer and immediate packaging for each pharmaceutical form in each container type (e.g. blister and bottle, vial and pen) in the smallest pack-size (see also “Transfer of Marketing Authorisation – Do I have to submit mock-ups and specimens?”). The revised product information (SmPC, Annex II, labelling, and package leaflet) in all EU languages including Iceland and Norway must be provided electronically in Word format (highlighted using track changes) and in PDF format (clean). The transitional period is the period between the date of notification of the Commission Decision on the Transfer and the implementation date.Moreover, a statement should confirm the status of the product in the market. Furthermore, a signed statement should confirm that no other changes have been made to the product information other than those to the details of the MAH and, if appropriate, the details of the local representatives.
How and to whom shall I submit my transfer of marketing authorisation application?
In practice it is an application supported by the same dossier as another application or authorised product leading to an independent marketing authorisation. An application through the simplified registration scheme can be made for homoeopathic medicinal products which meet the definition of a homeopathic medicinal product given in the Human Medicines Regulations. An application for a traditional herbal biatch registration can be made for herbal medicinal products with a long tradition of use. The application must be for the combination of active substances within a single pharmaceutical form, not a co-packaged combination of two (or more) separate medicinal products. Authorisations granted under Regulation 54 can be used as reference medicinal products after the 8-year period of data protection has expired.
The European Commission can impose on the marketing authorisation holder (MAH) the obligation to conduct post-authorisation measures. Interim results not impacting on the product information or on the description of the specific obligation can be submitted as a PAM as described below, if they are not part of the annual reassessment or annual renewal. The outcome of any pending variations submitted to the European Medicines Agency will not apply in NI.