In case you wish to extend the therapeutic indications of your orphan medicinal product to include additional non-orphan therapeutic indications, you will have to consider the following regulatory options: If the orphan designation is not yet withdrawn at time of submission, the marketing authorisation holder should undertake in their cover letter to request the withdrawal the orphan designation from the Community register not later than 2 days after the receipt of the CHMP opinion. blister and bottle, vial and pen) in the smallest pack-size (see also q9. POST JSON Data Upon receipt of a technically valid application, the Product Lead will perform the validation of the application content. Changes in the number of any unit (not restricted to the medicinal product) or changes in the specifications of any unit (not restricted to the medicinal product) contained in the pack will trigger a new EU number. An oral explanation to the CHMP can be held at the request of the CHMP or the MAH, where appropriate. Whether the CHMP or the PRAC will take the lead in the assessment of the variation will be decided at the time of the validation and communicated to the applicant through the assessment timetable. cURL If you want to ask a question or request information from EMA, please Send a question to the European Medicines Agency. ; HTTP GET #. Extension of indication, follow the principles outlined for initial marketing authorisation application (MAA) evaluations (see separate Q&A). Please submit annotated PIs in an anonymised format (i.e. A Transfer application follows a 30-day procedure following receipt of the application. Curl No mock-ups and specimens are required for Norway. The clock will be stopped until the receipt of the requested supplementary information. *Updated assessment reports are optional, depending on comments received by other committee members. For further information or guidance about how to create an EMA Account reference the guidance "Create an EMA Account". This means that the application will have to include the PIP decision including the deferral granted and if applicable, any completed studies. The type of question to be selected is Post-authorisation queries, followed by sub-optionVariation II scopes (Non-clin/Clin/RMP). The meeting highlights following each CHMP meeting give information on opinions in relation to new indications, changes to an existing indication and the addition, change or removal of a contraindication. Replacement of the primary or secondary packaging. revised product information. Check request.method == "POST" to check if the form was submitted. However, in case of type II variations concerning clinical safety to update the product information and/or the Risk Management Plan upon request by the PRAC, as a follow-up to a previous PSUR procedure or following a previous PRAC assessment of a signal, the PRAC will take the lead in the assessment of the variation. The Paediatric Regulation places some obligations for the applicant when developing a new medicinal product as well as new uses of an authorised product, in order to ensure that medicines to treat children are subject to ethical research of high quality and are appropriately authorised for use in children, and to improve collection of information on the use of medicines in the various subsets of the paediatric population. -H, --header: HTTP headers to send to the server with POST request.-d, --data: Data to be sent to the server using a POST request in the form of key/value pairs. A PDF version of the entire post-authorisation guidance is available: 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. The summary of the transferor's pharmacovigilance system in the MA dossier needs to be replaced in the transfer application with an updated summary of the transferee's pharmacovigilance system including: It is nevertheless required to update accordingly the information in the Article 57 database after the conclusion of the procedure for the MA transfer. The following requirements have to be met for the paediatric investigation plan (PIP) compliance statement to be included in the technical dossier: The MAH should submit the results of PIP studies or the remaining results if some were already submitted, as well as the elements mentioned above as part of a suitable variation or group of variations. In order to facilitate the registration of the submission, The applicant may provide relevant documents as attachments to the cover letter, e.g. Yahoo News - Latest News & Headlines Type II variations for a new indication, which is the same as the indication of an authorised Orphan Medicinal Product, should include relevant information in Module 1.7 of the application, based on the following considerations: In accordance with Article 8.1 of Regulation (EC) No 141/2000, where a marketing authorisation in respect of an orphan medicinal product has been granted in all Members States, the Union and the Member States shall not, for a period of 10 years, accept another application for marketing authorisation, or grant a marketing authorisation or accept an application to extend an existing marketing authorisation, for the same therapeutic indication, in respect of a similar medicinal product. The following minority of type II variations applications follow a monthly start date: Specific monthly start dates apply for variations involving the PRAC. Variations following a 60 day TT (= standard timetable): Variations assessed by the CHMP only or variations involving the PRAC (refer to question 'Is the PRAC Rapporteur involved in Type II Variations?') MAHs should avoid submitting variation procedures in parallel to a Transfer of MA application. The grounds for the re-examination request must be forwarded to the Agency within 60 days of receipt of the opinion. The MAHs are expected to complete the relevant validation checklist ( 9(2) of Regulation (EC) No 726/2004, also applies to CHMP Opinions adopted for Type II variation applications. Failure to register may cause delay in communication. upon publication. A Transfer of Marketing Authorisation (MA) is the procedure by which the MA is transferred from the currently approved Marketing Authorisation Holder (MAH) to a new MAH which is a different person/legal entity.. The 'QRD Convention' published on the Agency's website should be followed. If some results were already submitted, an overview table of the PIP results should be submitted in Module 1.10, indicating in which application(s) they were submitted, the status of the application(s) and the location of the last results submitted in the present application; The results of all studies conducted according to the PIP reflected in the SmPC and, as applicable. See also question How should parallel type II variations that affect the Product Information (PI) be handled? above. Upon receipt of the applicant responses the Agency aims to finalise the procedure by Day 20. The PL will serve as the main liaison person between the EMA product team, the Rapporteurs and the applicant. Clean versions should have all changes 'accepted'. Type-II variations: questions and answers - European Medicines The implementation date is the date on which the Transferee takes over ALL responsibilities as the Holder of the MA. However, if you have a procedural or regulatory pre-submission question when preparing your Type II variation application (Non-clinical/Clinical/RMP), please raise a ticket via the EMA Service Desk. Summary of main efficacy results - Module 5.3.5 of the dossier administrative validation checklist for initial marketing authorisation applications by applicants. For those variations which affect the Annex A (e.g. Where the CHMP requests the submission of a variation following the assessment of a post-authorisation measure (PAM), Specific Obligation (SO) or signal, MAHs must submit the corresponding variation application within the requested timeframe. The Agency does not accept stand-alone notifications of purchase order numbers that are not associated with a dossier. I am writing some code to interface with redmine and I need to upload some files as part of the process, but I am not sure how to do a POST request from python containing a binary file. Transfer of marketing authorisation: questions and answers Transfer applications should be presented as follows, in accordance with the appropriate headings and numbering of the EU-CTD format. As set out in Article 8 of the Paediatric Regulation, applications for new indication(s), new pharmaceutical form(s) and/or new route(s) of administration concerning an authorised medicinal product protected either by a supplementary protection certificate or by a patent which qualifies for the granting of such a certificate must include one of the following documents/data in order to be considered 'valid': This means that the application will have to include the PIP decision but also the results in accordance with the agreed PIP. Since cURL uses libcurl, it supports every protocol libcurl supports. Ideally, applicants must provide at submission an English and multi-lingual ('worst-case') colour mock-up of outer and immediate packaging for each pharmaceutical form in each container type (e.g. ). In the case the transfer procedure concerns a medicinal product whose name is constructed as [INN / common name + name of the MAH], the name of the medicinal product needs to be changed to reflect the name of the new MAH (transferee) through a Type IAIN variation (No. The MAH of the MA to be transferred is termed the Transferor. When addressing to the EC their request of removal from the Community register of orphan designated medicinal products, the MAH should also copy the Product Lead in the correspondence. When transferring the MA of a designated orphan medicinal product, the MAH must also transfer the orphan designation of the product concerned in accordance with Article 5(11) of Regulation (EC) No 141/2000 in order to maintain the orphan status. This requirement applies irrespective of the type of application submitted for such a change(s) i.e. The procedure for assessment will follow the usual procedure, as described in Applicants should include in the clinical overview a rationale supporting the proposed changes to the Product Information. The latter refers to both imposed (PASS category 1 and 2 in the RMP) and requested non-interventional studies (PASS category 3 in the RMP), and regardless of whether or not consequential changes to the product information are proposed. Use curl --data-urlencode; from man curl: This posts data, similar to the other --data options with the exception that this performs URL-encoding. ALPS is a data format for defining simple descriptions of application-level semantics, similar in complexity to HTML microformats. Type II variations which do not require any amendment of the marketing authorisation or which follow a yearly update of the respective Commission Decision can be implemented once the MAH has been informed of the favourable outcome by the Agency. In this case, if previously only a justification was submitted, the MAH/sponsor will be requested to provide a maintenance report. ) and submit it as a word document (as part of the working documents) in Module 1 as an Annex. The consolidation can be done at the time of any procedural milestone of the subsequent variation(s) e.g. See also question How should parallel type II variations that affect the PI be handled? above. At certain milestones during the evaluation procedure, the PL will contact the applicant for a direct exchange to facilitate the discussion on the scientific evaluation. CHMP guideline on conditional marketing authorisation This is because they are likely to require Commission Decision within two months from CHMP Opinion and discussion during the CHMP plenary meeting. . The acceptance by the Name Review Group (NRG) of the new name has to be finalised prior to the submission of the variation for changing the name of the medicinal product, including where the transferee wishes to use the common or scientific name, together with a trademark or the name of the MAH. Please see other relevant questions and answers in the EMA pre-authorisation guidance What is the role of the EMA product team?, Whom should I contact if I have a pre-submission question when preparing my Type II variation application (Non-clinical/Clinical/RMP)? In addition, the PRAC Rapporteur will systematically be involved in the assessment of all CHMP-led type II variations that include an updated RMP for the purposes of assessing the proposed RMP changes. The fee will become due on the date of the notification of the administrative validation to the applicant and fees will be payable within 45 calendar days of the date of the said notification. And after that, markets expect the central bank to come off its hawkish stance to lower inflation and slow down the pace of rate hikes unless data continues to show stubbornly hot inflation. In case the type II Variation affects the SmPC, Annex II, labelling and/or package leaflet, the revised product information Annexes must be submitted as follows: In addition, during the latter stages of the procedure there is often a need for fast informal exchanges between the MAH and the Rapporteur in preparation of the final CHMP opinion. Please also refer to the following questions which address paediatric related aspects Do I need to address any paediatric requirements in my type II variation application? and What is considered a new or modified therapeutic indication?. Agency requests for, Presenting all changes in a present/proposed format is a mandatory requirement in addition to the updated, Module 1.5.3 When the applicant requests consideration of an additional year of, Module 1.9 if applicable - Statement indicating that, Supporting quality, non-clinical and/or clinical data/study reports relating to the proposed, Changes which, in the opinion of the Committee, would benefit from a shortened assessment having regard to the urgency of the matter in particular for safety issues, English language: Revised complete set of, English language: The MAH should take into account the assessment feedback and provide revised versions of the highlighted, English language: complete set of finally agreed, All EU languages (incl. After approximately 15 days an invoice will be sent to the applicants billing address held on the Agencys file. At heart, Google Data APIs use Atom feeds and entries (XML) as a data format and HTTP as a protocol for data transmission - extending the Atom Publishing Protocol. Applicants are strongly recommended to apply for the compliance check before submission of the application to not delay the validation phase. Assessment of type II variations following a 60-day timetable may either follow a weekly or a monthly start date, depending whether the CHMP plenary meeting periodicity needs to be observed or not (See also question When shall I submit my application? above). 4. Can't use ES2017? variation or extension (or new marketing authorisation application) and irrespective of whether the change is related to adult or paediatric use. A PM will be nominated upon receipt of thevariation application. This applies to the English version and all the translations. The mock-ups should be sent by e-mail to mockups@ima.is. Commission Regulation (EC) No 847/2000 provides additional specific considerations for the definition of similar active substance applicable to chemical, biological and advanced therapy medicinal products. Any changes in the number of units of medicinal product or medical device being an integral part of the medicinal product (e.g. The Agency will inform the MAH of the applicable timetable in the validation confirmation e-mail. The MAH should therefore inform the Agency (Product Lead) of an upcoming type II application for a new indication at least 2 months before submission, so that the CHMP is informed of the future submission and can agree on the Co-Rapporteurs involvement. For clock-stops longer than 1 month the MAH should send a justified request to the EMA for agreement by the Rapporteur (and if the Rapporteur considers it necessary, by the CHMP). In such case, introduction of a new indication within the same marketing authorisation will have to comply with the standard data requirements. In case of comments on the mock-ups, the MAH should submit responses and/or updated mock-ups, as applicable, to the EMA (muspecimens@ema.europa.eu) prior to the specimen printing. If you want to ask a question or request information from EMA, please Send a question to the European Medicines Agency. POST Any question where guidance related to the evaluation procedure is needed. In addition, deadlines for submission of PIP or Waiver applications, application templates as well as Procedural Advice documents respectively regarding applications for PIPs, Waivers and Modifications and validation of new MAA, Variation/Extension applications and compliance check with an agreed PIP are available on the Agency's website in section Medicines for children. As explained in the question Which Committee will take the lead in the assessment of a type II variation? above, the PRAC Rapporteur is involved in and performs the primary assessment of PRAC-led variations. There is generally no requirement to notify the Agency in advance of an upcoming submission of a type II variation. Please also refer to Q&As on What aspects should I consider at time of submission of a type II variation if there are orphan medicinal products designated or authorised for a condition related to my proposed therapeutic indication?, Do I need to confirm the maintenance of my orphan designation when applying for a type II variation?, Can a non-orphan therapeutic indication be added to an already authorised orphan medicinal product? and Do I need to address any paediatric requirements in my type II variation application?. For variations following the weekly-start timetable, clock-stops in increments of weeks i.e. Although it is not very important, the CURLOPT_POSTFIELDS parameter data actually doesn't need to be converted to a string ("urlified"). IDM Members Meeting Dates 2022 NO+IS): complete set of annexes electronically only in Word format (highlighted), All EU languages (incl. Variations related to safety issues, including urgent safety restrictions, must be implemented within a time-frame agreed by the MAH and the Agency. The CAT will adopt a draft Opinion for all type II variations for ATMPs, including for PRAC-led ones, with the CHMP adopting the final Opinion. Grouped Type II variations, whether consequential or not, will each attract a separate Type II fee. Commission Regulation (EC) No 1234/2008 (the Variations Regulation) defines a major variation of type II as a variation that is not an extension of the marketing authorisation (line extension) and that may have a significant impact on the quality, safety or efficacy of a medicinal product. Opinions for monthly start variations involving the PRAC and not requiring Commission Decision within two months are adopted during the week of the PRAC plenary meeting. Page numbering should start with "1" (bottom, centre) on the title page of Annex I. The fields in the form should have name attributes that match the keys in request.form.. from flask import Flask, request, Further, a dedicated pool of Product Leads will be dealing with Quality Type II variations and related queries. These requirements are set out in Article 14-a of Regulation (EC) No 726/2004 and in Commission Regulation (EC) No 507/2006 and further elaborated in the respective The above principles also apply to mock-ups for Iceland. It should be noted that the CAT, instead of the CHMP, will take the lead in the assessment of type II variations for advanced therapy medicinal products (ATMPs), unless these are PRAC-led. cURL 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. This date is proposed by the Transferor and Transferee in the Transfer application will and be subject to agreement by the EMA. Introduction of an alternative immediate (primary) packaging made from a different material, Introduction of an alternative shape/dimension of a, The results of all studies performed and details of all information collected in compliance with an agreed, A decision of the EMA on a PIP including the granting of a deferral, The MAH to include in Module 1.10 of the dossier a positive outcome of full PIP compliance check by the. * = complete set of Annexes i.e. What groups of variations would be considered acceptable? ). non-clinical data, clinical pharmacology and/or clinical efficacy. You are POSTing the json incorrectly -- but even if it were correct, you would not be able to test using print_r($_POST) (read why here).Instead, on your second page, you can nab the incoming request using file_get_contents("php://input"), which will contain the POSTed json.To view the received data in a more readable format, try this: It should be noted that the CHMP will lead the assessment of a post-PSUR variation where the scope is related to other aspects of the dossier e.g. The MAH will receive the adopted timetable together with the request for supplementary information. BWP) or for immediate EC decision arise. From the response:. A PDF version of the entire post-authorisation guidance is available: 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. all SmPC, labelling and package leaflet texts for all strengths and pharmaceutical forms of the product concerned, as well as Annex II. The transitional period between the notification of the Commission decision on the transfer of a, Before Day B the Transferor is responsible for released batches. This allocated PM will be the contact point for this procedure. In case a PRAC Rapporteur is deemed necessary, he/she will be appointed. Please be reminded that in accordance with Union data protection requirements, no personal data should be included in the annotated PIs. After day C only the new MAH (Transferee) can release batches and place them on the market. There are no set submission dates. However, following adoption of the CHMP opinion it may be necessary to consolidate the adopted annexes for separate variations running in parallel, i.e. Further details can be found in the Harmonised Guidance for eCTD Submissions in the EU. The applicant should contact the PL for all questions regarding the evaluation procedure, including. In particular, if the PIP is completed and the results of all studies are available, the applicant should discuss whether the generated data support or not the intended paediatric indication(s) stated in the PIP. It 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. These variations will be handled separately from the transfer procedure. EMA expressly disclaims any liability or accountability for the presence of unnecessary personal data in the annotated PI submitted by the marketing authorisation holder. NO+IS): complete set of annexes electronically only in Word format (highlighted) and in PDF (clean). MAHs are strongly advised to contact the EMA in advance of the submission of the Transfer of application, in order to discuss how to handle any planned/ongoing procedures (especially in case the product information is affected) or in case there are variations linked to the Transfer procedure (see also Transfer of Marketing Authorisation Who should I contact if I have a question when preparing my application or during the procedure?). I wrote my POST code at the Java side. For Type II variations which introduce additional presentation/pack-size(s), each additional presentation/pack-size attracts separate fees (x additional presentations x separate fees). In such cases provided that the assessment of the MAH's responses could be dealt with in 30 days, an Opinion (or additional request for supplementary information) could be adopted at the next CHMP plenary meeting. 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