COVER LETTER BFARM

The cover letter should include the e-mail address of the person in charge. We provide consulting and training regarding eCTD and xEVMPD requirements and support the implementation of electronic submission and tracking systems in the pharmaceutical industry. Navigation and service Go to: Electronic submission of clinical trial applications Structure of the contents of the electronic data medium. Worksharing procedures have to be applied for at the CMD h. Notice to Applicants should be followed. This new Variation Regulation establishes new rules for the examination of variations to the terms of marketing authorisations for medicinal products for human use and veterinary medicinal products, granted in Centralised Procedures CP , Decentralised Procedures DCP or the Mutual Recognition Procedures MRP.

Templates for Summary of Product Characteristics and Package Leaflet Based on the 14th Amendment of the German Medicines Act, Sections 11 and 11a AMG , the structure and details of the user information for patients and healthcare professionals have been revised. Since both competent authorities are changing over to purely electronic processing of the documents step by step, the format of the electronic data carrier is becoming increasingly more important. 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. Retweet on Twitter exalon Retweeted. This revision has brought them in line with European requirements.

cover letter bfarm

The amended German texts are not needed before the national phase is started. If ionising radiation treatment is used during manufacture, an Application for marketing authorisation xover view of treatment with ionising radiation during manufacture Section 1 subsection 2 sentence 1 No.

Navigation and service

This Page Recommend page. Navigation and service Go to: This structure shows a major similarity to the submission formats of other European authorities. This new Variation Covwr establishes new rules for the examination of variations to the terms of marketing authorisations for medicinal products for human use and veterinary medicinal products, granted in Centralised Procedures CPDecentralised Procedures DCP or the Mutual Recognition Procedures MRP.

  HOW TO PROMOTE 1MALAYSIA CONCEPT ESSAY

Notice to Applicants, Module 1. The cover letter should include the e-mail address of the person in charge.

Sample folder for the electronic submission size: When filled in completely, with due regard to the European requirements valid at the time as stated in Eudralex Vol. Welcome to Exalon Your partner for high bfaarm eCTDs, regulatory submission services and EVMPD support Our highly experienced team of regulatory affairs, documentation and IT professionals coverr a comprehensive set of services covering all aspects of the electronic drug regulatory affairs business.

While the first guideline provides detailed operational advice as well as information on the documentation to be submitted, the second provides details of the variation categories i. Further current information is available on the CMD h Web page: Several annotations have been integrated so that it will not be necessary to constantly consult the information published on the EMEA website by the QRD group.

Consequent use of these templates will encourage a consistent and smooth implementation. Electronic cver of clinical trial applications Structure of the contents of the electronic data medium.

cover letter bfarm

Further current information is available on the CMD h Web page:. Not a very wise move: 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.

BfArM – Clinical Trials – Electronic submission of clinical trial applications

Navigation and service Go to: 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. Regarding the formal arrangement of the dossier Modules 1. If Type IA or IB variations include alterations of the German texts, submit highlighted and clean versions along with the initial application; this applies to electronic submissions as well see the AMG -Submission Ordinance.

  DISSERTATION 2011 MHH

This revision has brought them in line with European requirements. We provide consulting and training regarding eCTD and xEVMPD requirements and support the implementation of electronic submission and tracking systems in the pharmaceutical industry. Petter following remarks may be helpful: The ZIP archive contains the following folder structure: 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 bfar, the future.

These templates btarm also be used for the compilation of core texts as well as for the notice of marketing authorisation. This Page Recommend page. In addition to our electronic publishing services we support the registration of your medicinal products in xEVMPD in acc.

Worksharing procedures have to be applied for at the CMD h.

Retweet on Twitter exalon Retweeted. Notice to Applicants – “User guide for the application form”.