Further current information is available on the CMD h Web page:. Our services include submission hosting, processing of individual submission documents as well as consultancy in all questions of electronic drug regulatory business. Regarding the formal arrangement of the dossier Modules 1. The following remarks may be helpful: Our highly experienced team of regulatory affairs, documentation and IT professionals provides a comprehensive set of services covering all aspects of the electronic drug regulatory affairs business. Structure of the electronic data carrier. If a licence is sought in a purely national authorisation procedure, the application form needs to be filled out in German in accordance with Section 22 sub-section 1 AMG.
If ionising radiation treatment is used during manufacture, an Application for marketing authorisation in view of treatment with ionising radiation during manufacture Section 1 subsection 2 sentence 1 No. Structure of the electronic data carrier. When filled in completely, with due regard to the European requirements valid at the time as stated in Eudralex Vol. In the variation application form, use the full German name of the medicinal product as it is authorised, and indicate the German marketing authorisation holder as well as the Germanmarketing authorisation number. The cover letter should include the e-mail address of the person in charge. Notice to Applicants, Module 1.
Our highly experienced team of regulatory affairs, documentation and IT professionals provides a comprehensive set of services covering all aspects of the electronic drug regulatory affairs business. These templates will also be used for the compilation of core texts as well as for the notice of marketing authorisation.
Our services include submission hosting, processing of individual submission documents as well as consultancy in all questions of electronic drug regulatory business.
Structure of the contents of the electronic data medium. If Type IA or IB variations include alterations of the German texts, submit highlighted and clean covr along with the initial application; this applies to electronic submissions as well see the AMG -Submission Ordinance.
Navigation and service
In addition to our electronic publishing services we support the registration of your medicinal products in xEVMPD in acc. This Lettr Recommend page. The set of forms is available via the above mentioned link as a template that can be completed. Consequent use of these templates will encourage a consistent and smooth implementation. Worksharing procedures have to be applied for at the CMD h. Not a very wise move: Notice to Applicants should be followed.
This Page Recommend page. Navigation and service Go to: This structure shows a major similarity to the submission formats of other European authorities.
Retweet on Twitter exalon Retweeted. Information on how to fill in the application form is published in Eudralex Vol. Templates for Summary of Product Characteristics and Package Leaflet Based on the 14th Amendment of the German Medicines Act, Sections 11 and 11a AMGthe structure and details of the user information for patients and healthcare professionals have been revised.
Section 7 1 of the Ordinance on GCP lays down that applications for the authorisation of a clinical trial must be submitted in a paper version and the application form as well as the documents to be attached mustin addition, also be submitted to the federal competent authority on an electronic data carrier.
In order to ease implementation of these new requirements, BfArM provides templates for Package Leaflets for over-the-counter and prescription-only products as well as for SPCs. Structure of the electronic data carrier.
Further current information is available on the CMD h Web page: These German templates have been drawn up in accordance with the QRD Templates stands for Quality Review of Documents so that there should be no major structural differences in the future.
We are publishing eCTD submissions for of all types of applications e. If this is the case, the submission of the original of the application bearing the applicant’s signature and one electronic data carrier will suffice. The cover letter should include the e-mail address of the person in charge.
The ZIP archive contains the following folder structure: Navigation lettdr service Go to: When filled in completely, with due regard to the European requirements valid at the time as stated in Eudralex Vol. The amended German texts are not needed before the national phase is started.
BfArM – Clinical Trials – Electronic submission of clinical trial applications
The two guidelines are available on the Web page of the European Commission. Several annotations have been integrated so that it will not be necessary to btarm consult the information published bfarj the EMEA website by the QRD group. We provide consulting and training regarding eCTD and xEVMPD requirements and support the implementation of electronic submission and tracking systems in the pharmaceutical industry. Electronic Common Technical Document. Sample folder for the electronic submission size: