Variations to medicinal products can be classified in different categories, depending on the level of risk to public health and the impact on the quality, safety and efficacy of the medicinal product concerned. Such applications may be required when the product in full compliance with the details of the marketing authorisation cannot be sourced for a short, defined period of time maximum of 6 months. No paper applications should be submitted. According to this Directive, the requirements for national applications are similar to those for European procedures and work sharing and grouping of variations is possible. For veterinary medicinal products, the RMS can still allocate variation procedure number upon request. Grouping including more than one MA in the mutual recognition procedure type IA only Worksharing In these cases, the variation procedure number needs to be obtained from the Reference Authority.
To ensure continued availability of a medicinal product on the market in Malta, batch specific requests can be submitted. No other changes that are not covered by the variation application are to be included in the product information. A formal letter with the work-sharing applicant and contact person for the work-sharing procedure should be provided with the work-sharing application. The cover letter should include the e-mail address of the person in charge. The following remarks may be helpful: Marketing authorisation holders are strongly discouraged from applying for a BSR when a batch does not comply with the registered finished product specifications.
Day 90 is the commencement of national phases. In this case these variations cannot be submitted with an approval from another country since legal classification is at the discretion of each Member State.
For further information on electronic submissions see “Electronic submissions “in the left margin. This guideline is for use by marketing authorisation holders applying for a national change in the legal classification for supply of a medicinal product from dover to a medical prescription” to “not subject to a medical prescription”.
Human medicines – Regulatory and procedural guidance – Post-Marketing Authorisation. Guideline on categorisation of extension applications EA versus variation.
Two Commission guidelines have been issued in connection with the a. Guideline on fast track procedure for human influenza vaccines. Electronic submissions and the use of the gariation application form are outlined in the section on Submission Requirements. The MAH must submit the variation application for work-sharing at the latest by the recommended submission dates published under submission dates.
When PL and labelling are affected, these should also be submitted in the same format. Please note that review articles, core data sheets and extracts from texts books are not considered detailed enough for the scientific assessment. Classification of Variations Variations to medicinal products can be classified in different categories, depending on cober level of risk to public health and the impact on the quality, safety and efficacy of the medicinal product concerned.
In the national procedure, the procedure is re-started upon receipt of the response. Retweet on Twitter exalon Retweeted. Guideline on stability testing for applications for variations to a marketing authorisation.
The following is a list of mandatory documents to be submitted to the Medicines Authority for a variation to a nationally authorised product: This excludes variations to change legal classification prescription status.
Our varjation include submission hosting, processing of individual submission documents as well as consultancy in all questions of electronic drug regulatory business. The amended German texts are not needed before the national phase is started.
For European variation procedures, no further approval letter will be issued by the Medicines Authority and variations can be considered approved in Malta following approval confirmation by the Reference Member State without prejudice to any other national legislation in place e. To ensure continued availability of c,dh medicinal product on the market in Malta, batch specific requests can be submitted. No other changes that are not covered by the variation application are to be included in the product information.
Q&A about Variations -The Worksharing Procedure – Acorn Regulatory
Where changes to the outer pack, immediate pack and package leaflet are being proposed, mock-ups with all the differences highlighted should be submitted.
A copy of the ticked conditions met and documents submitted as per the categorisation guideline if applicable. The Medicines Authority follows coveg following system for issuing of approvals for variations, notifications and renewals.
If the applicant finds it necessary to implement IA and IAIN variations in the product information before the MPA has sent out approval letters, applicants can enter a new date of revision in the product information.
For the applicant to respond to questions or provide updated CMC documents there is a clock- lettdr. Total evaluation time excluding clock stop is given within the parenthesis.
Navigation and service
If the applicant has a harmonised dossier in more than one EU market they could request the dossier to be converted to a de-centralised rather than nationally approved dossiers in the relevant markets. Requests for variation procedure numbers should be sent to email address: We work with clients assisting them with issues just like this all of the time. It is important that application forms for variations are filled in correctly and that all the documents that should be appended to the application form are submitted in accordance varition the categorisation guidelines.
For the assessment of Type 1B and Type II variations which are submitted nationally many competent authorities in the EU do not have a time-table and varaition can make the implementation of a change which impacts a lot of markets very difficult from a supply chain perspective. Further current information is available on the CMD h Web page:. In all other cases, we ask the applicant to await the approval letter with updated product information prior to the amendment in question is implemented in the product information.