Information for marketing authorization holders on the transitional arrangements of the new pharmacovigilance legislation
Please note that the Hungarian Decree of the Ministry of Human Resources on Pharmacovigilance implementing the measures introduced in Directive 2010/84/EU has been announced on 22 August 2012. It is available only in Hungarian language.
Risk Management Plan (RMP)
Submission of a Risk Management Plan in a marketing authorization application
All applicants submitting an initial marketing authorization application (MAA) after 2/21 July 2012 irrespective of the legal basis of their MAA are required to submit an RMP.
For initial marketing authorization applications pending on 2/21 July 2012 and not containing an RMP, there is no obligation to submit an RMP during the course of the evaluation procedure. The submission of an RMP is not required for an application for a traditional herbal medicinal product, nor for a homeopathic medicinal product. For other herbal or homeopathic medicinal products not falling within the scope of the traditional use registration or simplified registration respectively, an RMP will be required for any initial marketing authorization applications after 2/21 July 2012.
Format of the RMP
The new format of RMPs can be found in the Commission Implementing Regulation published by the European Commission on 19 June 2012. A 6-month transitional period (that will last until 10 January 2013) came into force on the day of the publication of the Commission Implementing Regulation, during which, applicants and marketing authorization holders can either use the old (Volume 9A) or new (Commission Implementing Regulation) format. The template for the RMP will be updated and this is expected to be available around September 2012.
Publication of the summary of RMP on the national web-portal and the European medicines web-portal
Marketing authorization holders are reminded that a summary of the RMP will be published on the national or the European medicines web-portal. This requirement also applies to existing medicinal products with an RMP. After the RMP gained acceptance during the evaluation procedure, applicants shall submit the Hungarian summary of the RMP. The time of submission must be before the end of the evaluation procedure. As for already existing RMPs authorized via the national or MR/DC procedures where Hungary acted as RMS, MAHs are requested to submit a Hungarian summary thereof to the Institute by 31 December 2012 at latest. Regarding procedures where Hungary acted as a CMS, the schedule of submission and content of the summary shall be agreed upon by the RMS, and a Hungarian summary should be submitted thereafter. As for the summary of the RMP for centrally authorized medicinal products, the guidance of the EMA shall be followed.
The summary of the RMP will follow the new format and content as set out in the Commission Implementing Regulation and as detailed in the relevant GVP module.
Pharmacovigilance System Master File (PSMF) and the summary of the pharmacovigilance system
4.1 Submission of the summary of the pharmacovigilance system in the marketing authorization application (and introduction of the PSMF)
After 2 July 2012 (for CAPs) and 21 July 2012 (for NAPs), instead of a Detailed Description of Pharmacovigilance System (DDPS) applicants are required to include a summary of the pharmacovigilance system in the initial marketing authorization application in Module 1.8.1 of the dossier. The PSMF will take the role of the DDPS, and even if the PSMF will not be provided on a routine basis for assessment, the document itself and the system behind it must be established by the time of the submission of the initial marketing authorization application.
The new requirement (summary of the pharmacovigilance system included in the dossier and the establishment of the PSMF) will replace the old regulation (DDPS) according to the following schedule:
· An initial marketing authorization application can only be initiated according to the new requirement
· For existing and pending marketing authorizations (MAs), the switch from the DDPS to the PSMF shall take place according to the following timeline, whichever is the earlier
- At the time of submission of the renewal application,
- At time of the annual renewal for a conditional marketing authorization through the centralized procedure,
- By 2/21 July 2015 at the latest.
These requirements apply to all existing MAs with or without a detailed description of the pharmacovigilance system (DDPS) in their dossier.
Applicants or marketing authorization holders may introduce the PSMF before the aforementioned deadlines, provided that the PSMF fully complies with the new legal requirements.
For pending initial marketing authorization applications and renewal applications on 2/21 July 2012, there is no obligation to replace the DDPS with the summary of the pharmacovigilance system and introduce the PSMF during the course of the evaluation procedure.
A variation shall be submitted when introducing the PSMF and the summary of the pharmacovigilance system (except for initial MAAs and renewals), the classification of which will be defined in the revised classification guideline that will be published soon. It is expected to be a Type IAin variation – for further information please refer to the CMDh website.
Please be informed that the 'master file' introduced temporarily on a national level in 2010, by the Institute, does not correspond either in content, or in format to the PSMF that comes into effect on 2/21 July 2012.
Introduction of changes to the summary of the pharmacovigilance system
From those elements included in the pharmacovigilance system summary, changes to the QPPV and/or QPPV contact details and/or to the PSMF location will require the submission of a variation application in accordance with the variation classification guideline. It is expected to be a Type IAIN variation. For further information please refer to the CMDh website.
Introduction of the PSMF and the summary of the pharmacovigilance system for traditional herbal and homeopathic medicinal products
The requirement to operate a pharmacovigilance system and to maintain and make available on request a pharmacovigilance system master file also applies to traditional herbal and homeopathic medicinal products. However, the requirement to submit a summary of the pharmacovigilance system in the application dossier does not apply to them.
For other herbal medicinal products not falling within the scope of the traditional use registration, are not exempted from submitting a summary of the pharmacovigilance system.
Post Authorisation Safety Studies (PASS)
Information on the authorization of PASS can be requested from the Clinical Trials Unit.
Adverse drug reactions originating from non-interventional PASS that need to be submitted on an expedited basis shall be reported to EudraVigilance, simultaneously to the IDs OGYIP and EVHUMAN.
The obligation to submit the renewal application 9 months before the expiry of the marketing authorization applies to medicinal products for which the marketing authorization expires after 2/21 April 2013.
The new requirements on the content and procedure for a renewal which are set out in the updated guideline will apply as of 2/21 July 2012. Therefore any renewal applications submitted after 2/21 July 2012 will have to comply with the new requirements and will follow the new procedure.
PSUR, PSUR addendum, Summary Bridging Report and line listing should no longer be submitted as part of the renewal application. Therefore, in the first months of implementation it is particularly critical that the clinical overview includes relevant information to support the benefit-risk re-evaluation of the medicinal product.
Local Pharmacovigilance Contact
Please note that the Hungarian Decree of the Ministry of Human Resources on Pharmacovigilancestates that a Hungarian pharmacovigilance contact shall be appointed whenever the EU-QPPV does not reside in Hungary. The qualification requirement for the local contact is a diploma in life sciences, chemistry or chemical engineering. Furthermore, the local contact shall be adequately trained in pharmacovigilance (either by the MAH or receive an equivalent training acknowledged by the MAH) to regularly report to the EU-QPPV in pharmacovigilance matters.
Please notify the Institute via firstname.lastname@example.org the appointment or any changes of the local pharmacovigilance contact person.
The same notification procedure should be followed regarding the person of the EU-QPPV (irrespective of his/her country of residence), along with the submission of the appropriate variation application.
Further information on the transitional arrangements of the new pharmacovigilance legislation can be found in the Question and Answer document of the EMA. First wave of GVP modules already finalized have been published and are available at the EMA website.