Revised topics are marked ‘New’ environmental studies questions and answers pdf ‘Rev. 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. MAHs must in all cases comply with the requirements of Community legislation.
Provisions that extend to Iceland, Liechtenstein and Norway by virtue of the European Economic Area agreement are outlined in the relevant sections of the text. The existence of such a system of PAMs does not aim at promoting premature approvals of marketing authorisations or post-authorisation procedures. The background and rationale for requesting PAMs will be described in the relevant assessment, which will present the context and nature of the PAM. PAMs are classified into their appropriate legal framework under which they will be enforced.
PAMs other than specific obligations can be required for any type of authorisation and will be included in the opinion of an initial marketing authorisation or further to the committees’ assessment during post-authorisation. The wording of the PAM will describe the issue under investigation that has led to the request together with a clear outline of the studies or activities expected to address it and the deadline for its submission. Compliance with these measures is defined by both the submission of the requested data and adherence to the agreed timeframe. 1These codes relate to the Agency’s product and procedure tracking database called SIAMED and will be used, together with a numbering system, to identify each PAM of a medicinal product both in the database and in any correspondence of the Agency with the MAH. What is a specific obligation ? Continuation of a marketing authorisation under exceptional circumstances or the renewal of a conditional marketing authorisation will be determined by the MAH’s compliance with the specific obligations, which are checked annually as part of either the annual reassessment or the annual renewal procedures. 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.
How and to whom shall I submit my PAM data? In case of interim results impacting on the product information, a variation should be submitted without waiting for the annual re-assessment or annual renewal. Final results leading to the fulfilment of the specific obligation should be submitted within an appropriate procedure, i. What is an annex-II condition ? These obligations can be imposed at the time of the granting of the marketing authorisation or later, as conditions to the marketing authorisation.
These are conditions to the marketing authorisation included in Annex II. These can consist of post-authorisation safety or efficacy study. As annex-II obligations are binding conditions to the marketing authorisation, any modification proposal by the MAH with regards to their description or due date has to be submitted as a variation application. Interim results not impacting on the product information or on the condition as stated in the Annex II can be submitted as a PAM as described in question How and to whom shall I submit my PAM data? Final results leading to the fulfilment of the Annex II condition should be submitted as a variation application. What is an additional pharmacovigilance activity in the risk-management plan ? All relevant milestones, together with their due dates should be included in the summary table of additional PhV activities in the RMP.
The MAH has the obligation to provide the requested data within the stated timeframes. PAM as described in question How and to whom shall I submit my PAM data? Submissions of final study reports leading to the fulfilment of a MEA should be addressed via the appropriate variation procedure. Should I submit a variation to fulfil a PAM? What is a legally binding measure ?
As such, they have to be fulfilled by the MAH upon request of the Agency and its committees. Submission of final results of study involving paediatric patients submitted in fulfilment of Article 46 of the paediatric regulation. PAM type in point 12 of the cover letter. Therefore, MAHs are encouraged to use the template for the cumulative letter of recommendations to acknowledge these recommendations.
No deadline needs to be mentioned. Can the classification of my PAM change during its lifecycle? When should I submit my PAM? II, the RMP or the respective committee assessment. Assessment of PAM data submitted after the recommended submission date will start in accordance with the start date of the following month. 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. Changes to the due date for a SOB, Annex II condition or category 3 study in the RMP should be submitted as type IB variation category C.
Changes to category 4 studies listed in the RMP can be updated in the context of any other RMP update. Under which procedure should I submit my PAM? Conditional renewal, annual re-assessment or type II variation, depending on the timelines. Where the deliverable of a measure is submitted as part of another procedure, the structure of the submission package should follow the requirements of this procedure and the MAH should indicate in the template table of cover letter of the application which PAM is being addressed, including the EMA reference number and the full description of the relevant PAM. How should I structure my PAM submission dossier?