The advertisement of the alpha of the action will specify the modalities for acquiescence of abstracts accordant to the action (e.g. acknowledgment to the Pharmacovigilance Accident Appraisal Committee (PRAC) account of questions, comments to the accurate accomplishments acknowledging the triggering of the procedure).
Considering the coercion of the matter, all advice accessible by stakeholders (e.g. business authorisation holders (MAHs), healthcare professionals, patients’ organisations, accepted public) charge be provided by the date appear in the announcement.
Marketing authorisation holder(s) (MAHs)
The MAHs of articles anxious by the action should abide their responses as follows:
Published abstracts can be presented as admiring affidavit in acknowledgment to a specific catechism if no added abstracts is available.
In case some questions (e.g. on a specific biologic form) are not applicable/relevant to all product(s) anxious by the action or to the product(s) of the represented group, the acknowledgment should be “not applicable” with a abbreviate explanation.
It should be acclaimed that the albatross for the affection of the submitted affidavit lies with the MAHs and is acute to the all-embracing appraisal of the assurance issue. All submissions are accepted to be submitted in English and electronically alone (please accredit to Catechism 20). Acquiescence of responses apropos the Article 31 Pharmacovigilance barometer with commendations to centrally authorised articles (CAPs) should chase the requirements for post-authorisation procedures for CAPs (e.g. acquiescence via e-CTD).
In case MAHs formed a accumulation (please accredit to Catechism 12), the awning letter accompanying the distinct circumscribed acknowledgment and/or appeal for articulate account should acutely yze the parties amenable for the submission/request.
All submissions from added stakeholders who are not the MAHs anxious by the procedure, (e.g. healthcare professionals, patients’ organisations, accepted public), accept to be accompanied by a acquiescence anatomy with all its binding fields appropriately completed. This is a claim for abstracts to be brash for assessment. The acquiescence anatomy arrangement is accessible in the advertisement of the burning abutment action that has a committed area for acquiescence of abstracts by stakeholders who are not MAHs.
The added claim is the acquiescence of all abstracts aural the borderline defined in the announcement.
In all cases, abstracts submitted should be accompanied by an all-embracing arbitrary of its agreeable and should accomplish advertence to the specific PRAC catechism actuality addressed (as per PRAC appear account of questions numbering).
It is of the absolute accent that abstracts is provided in due advance to abstain abrasive the assurance review. In the aforementioned sense, due attention should be accustomed to timelines constraints in the accident of requirements for translations above-mentioned to assessment. Considering this aspect aural the attributes and timeframe of an burning abutment procedure, abstracts acquiescence in English and electronically is accordingly acerb advised.
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