A PDF version of the entire post-authorisation guidance is available: The data presented in the submissions should be intended exclusively for the purposes of the concerned procedure. The review of proposals for the summary of product characteristics, package leaflet and labelling is an integral part of the documentation assessment. Requests for a reduced timescale should be made to variationqueries mhra. For products authorised nationally since with the PMA-MA process transitional arrangements , and which therefore had been on the market in Malta for a number of years before accession, the granting of the first MA in accordance with the Acquis Communautaire can be considered as a re-assessment of the benefit-risk of the product.
The Medicines Authority will still, however, issue a renewed licence with unlimited validity, when authorising other post-authorisation processes. The reference member state, where the product has been authorised via national procedure is forwarding its assessment report to other member states in the procedure. Depending on the result of the review, the marketing authorisation may be renewed for an unlimited period or the marketing authorisation is to be renewed after the following five years. It is an internal document of the Agency, where information on the content review of every documentation part is documented with a critical overview on the essential data for adopting an opinion. However, they shall provide case narratives in the relevant risk evaluation section of the PSUR where integral to the scientific analysis of a signal or safety concern in the relevant risk evaluation section. This form is a guide only.
The explanatory note highlights and addresses challenges specific to the EU single assessment for nationally authorised products. This will apply to all procedure types, including national procedures.
The review of proposals for the summary of product characteristics, package leaflet and labelling is an integral part of the documentation assessment. An advice note will be generated at the data lock point DLP date and sent accordingly to the relevant QPPVs in order to ensure the accurate identification of the chargeable units for the products involved in cover letter renewal cmdh procedure.
Medicines Database After granting a marketing authorisation, basic information on the authorised medicine, including the approved summary of product characteristics and package leaflet and the public assessment report for medicines whose applications were submitted after Croatia’s cover letter renewal cmdh to the EU 1st July are being published in the Medicinal Products Database of the HALMED webpages and are publically available.
You can apply for: How to identify the official contact person for the PSUR? Yes this page is useful No this page is not useful Is there anything wrong with this page? For the assessment of the full non-clinical and clinical documentation, or all applications encompassing proper non-clinical and clinical trials, or those published in the literature, in addition to HALMED’s assessors, external experts mostly doctors specialists in certain therapeutic areas, having specific practical knowledge and experience in the treatment of indications concerned are appointed, thus contributing to the quality of assessment.
The decentralised procedure DCP for granting a marketing authorisation means that cover letter renewal cmdh marketing authorisation procedure starts at the same time in the reference member state and other EU member states cover letter renewal cmdh in the procedure.
If a translation is considered not to be of an acceptable quality, the Member State concerned will inform the MAH and the Agency within 3 days of receipt of the translation.
MHRA needs to approve major variations before they are made. After the co-ordinator has collected all reports in a single marketing authorisation procedure, the dossier is forwarded to the Committee for medicinal products composed cover letter renewal cmdh HALMED staff members and depending on the occasion, from external experts.
One example of a major change is adding a new therapeutic indication to a product or updating the current indication the medical needs the product is used for.
If, howeverthe dossier of a medicinal product authorised through the PMA-MA process is being renewed in another Member State, a renewal application should be submitted to the Medicines Authority for the dossier to be kept up to date with the latest information, regarding, in particular the efficacy and safety of the product.
For information regarding renewals of parallel import licences please refer to this link. Proposals for worksharing applications should be sent to:. The request and its grounds should be considered cover letter renewal cmdh the PRAC and the CHMP if it concerns at least one marketing authorisation granted in accordance with the centralised procedure or the CMDh otherwise, which will either approve or cover letter renewal cmdh the request. You can see details of this in the annex of the EU guidelines.
This is a legally binding requirement from the EU pharmaceutical legislation. Relevant Information Information on submission requirements with respect to electronic cover letter renewal cmdh paper copies required can be found here. After granting a marketing authorisation, the marketing authorisation holder is obliged to report to HALMED all variations to the previously authorised documentation throughout the medicinal product life cycle. The EMA has published further guidance on how the fees are calculated and collected.
For generic products or others not directly involved in the PSUSA procedure itself, the changes have to be submitted via a variation procedure according to the timelines indicated in the table below. Meetings of the Committee are held every week in permanent assembly and depending on the need in extended assembly.
The documentation for centrally authorised medicinal products is scientifically cover letter renewal cmdh by the European Medicines Agency EMA and the marketing authorisation valid in all EU Member States is granted by the European Commission.
Medicines: apply for a variation to your marketing authorisation
In cover letter renewal cmdh no changes to the product information are being proposed as part of the PSUR, the MAH should not include any product information within the EU regional appendix. It is the responsibility of the marketing authorisation holder to check regularly the list of EU reference dates and frequency of submission published in the European medicines web-portal to ensure compliance with the PSUR reporting requirements for their medicinal products.
In this case, the reference member state is assessing the product documentation for the first time with active participation of all member states concerned. The Agency will inform the MAH of the insufficient quality of the translations and the transmission to the Commission will be delayed until receipt of the amended translation which would be expected within 1 week.
After granting a marketing authorisation, basic information on the authorised medicine, including the approved summary of product characteristics and package leaflet and the public assessment report for medicines whose applications were submitted after Croatia’s accession to the EU 1st July are being published in the Medicinal Products Database of the HALMED webpages and are publically available.
Conclusions on deficiencies After the meeting and endorsement of minutes, according to the Committee’s conclusions, individual co-ordinations prepare the Conclusion on deficiencies in the documentation and an official letter to the applicant containing questions and comments with regard to the submitted documentation and request for additional documentation, if the submitted data is not sufficient for a positive quality, safety and efficacy assessment of the medicinal product.
If the data contained in the PSUR contribute meaningfully to the scientific assessment, these data should be included in the scope of the PSUR procedure. Standards of translation of Annexes The structure of the English Annexes has to be strictly followed and should be exactly translated as per the adopted English version i. Back cover letter renewal cmdh top 1.
Proposals for worksharing applications should be sent to: Cover letter renewal cmdh and clinical assessors review the documentation on non-clinical investigations in animals and clinical investigations in humans carried out during the medicinal product development phase in order to prove the safety and efficacy.
Related content Explore the topic Marketing authorisations, variations and licensing guidance Policy Patient safety. In cases where the wording has cover letter renewal cmdh be adapted, cover letter renewal cmdh type IB under category C.
The last, fourth procedure for granting a marketing authorisation in the EU is the national procedure, that is being carried out when the applicant wishes to market the product in only one member state and the marketing authorisation is granted nationally and valid only on this country’s territory. You will be able to contact this PM throughout the procedure. The MHRA will take up to 30 cover letter renewal cmdh to process your application.